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North Carolina CRO Collaborative

NC's Contract Research Organizations

Research. Patients. Data. Results.

Contract research organizations (CROs) operate in many capacities to support the work of healthcare innovators and help move therapies from idea to market. CROs support pharmaceutical, biotech and medical device companies and research institutions with a wide range of services, including:

Clinical Trials Management
Patient Recruiting
Project Management
Regulatory Affairs

NCBiotech is working with partners from around the state to drive strategy and support of North Carolina's CRO industry. By working together to expand the clinical-based workforce and awareness of NC's CRO community, North Carolina will continue to be a global leader in this key life science sector.

About NC's CRO Industry
The NC CRO Collaborative
Academic Programs
Explore Career Options
Industry News

North Carolina Clinical Trial Management Companies and Support Organizations — *Clinical Trial Management Companies and Support Organizations in North Carolina*

North Carolina: The Birthplace of CROs

In the early 80s, contract research pioneers Quintiles, now IQVIA, and PPD were both founded in North Carolina.

Today, CROs are dispersed throughout the state, with major clusters in the Research Triangle region and southeastern NC, providing easy access to life science companies who are ready to move into the next stage of commercialization.

North Carolina's CRO industry includes companies and support organizations that have a strong focus in clinical trial management. The functions of these companies include clinical study management and monitoring, project management and patient recruitment.

View of complete list of clinical trial companies in the NCBiotech Company Directory.

Clinical Trial Management Landscape in NC

4,500+

open clinical trials

250+

companies & support orgs.

13,000+

employees

Currently in North Carolina, there are more than 4,500 open clinical trials. This includes trials that are active as well as enrolling by invitation and preparing to recruit.

The state's clinical trial management industry includes over 250 companies that are specialized in clinical trial management and support organizations that offer a variety of services. The companies that are specialized in clinical trial management employ more than 13,000 people.

The North Carolina CRO Collaborative

NCBiotech has convened a group of industry and academic partners in this sector, called the North Carolina CRO Collaborative, to address challenges and develop solutions that will strengthen the CRO industry in North Carolina. One goal of this dedicated initiative is to grow the clinical trial management workforce in North Carolina. Learn more about the Collaborative.

CROs with NC Headquarters

North Carolina CRO Collaborative

The North Carolina CRO Collaborative was brought together to address and support the needs of the CRO industry. The immediate goals of the CRO Collaborative are to improve and expand clinical-based workforce development in North Carolina through curriculum enhancement and development as well as increase awareness of CRO industry trends and career opportunities throughout the state.

The committee is comprised of representatives from eight CROs, eight academic institutes (both clinical research training programs and university-affiliated clinical site programs), and one hospital system.

The CRO Collaborative has recently developed ten job profiles which can be used to educate students about career opportunities in the CRO industry.

Industry Partners

Cato Research

Cato Research provides contract research services, including preclinical and clinical study design and management, regulatory assessments, data management and statistics, CMC program management, medical writing and submission of regulatory documents.
Covance

Covance, the drug development business of LabCorp, provides a wide range of early-stage and late-stage product development services primarily to the pharmaceutical and biotechnology industries.
Duke Clinical Research Institute

Duke is one of the largest biomedical research enterprises in the country, with nearly $798 million in sponsored research expenditures annually. The Duke University School of Medicine includes the research efforts of more than 2,500 basic science and clinical faculty members who strive to transform medicine and health, locally and globally, through innovative scientific research and rapid translation of breakthrough discoveries. Their research, which extends from the bench to the bedside, has resulted in some of the world’s most significant medical and biological discoveries and has resulted in innovative new treatments for a wide range of human diseases.
IQVIA

IQVIA provides technology-enabled healthcare services to help biotech, medical device and pharmaceutical companies develop new therapies, identify unmet treatment needs and understand the safety, effectiveness and value of pharmaceutical products.
NCBIO

NCBIO is the trade association for the North Carolina life science industry. Its members include clinical research organizations, pharmaceutical, biologics, and medical device companies, and other life science and supporting businesses.
PPD

PPD is a global contract research organization that provides comprehensive, integrated drug development, laboratory and lifecycle management services to pharmaceutical, biotechnology, medical device, academic and government organizations.
PRA Health Sciences

PRA Health Sciences partners with biotech and pharmaceutical companies to conduct clinical research and trial services for all phases of drug clinical development. In short, PRA does our part to ensure life-saving drugs get to market.
PSI

PSI is a privately-owned, full-service clinical research organization operating globally. PSI’s global reach supports clinical trials across multiple countries and continents, and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its employees, sponsors, sites, and vendors.
Syneos Health

Syneos Health is an end-to-end, fully integrated biopharmaceutical solutions company that works differently – bringing together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.

Academic Programs and Clinical Sites

Cabarrus College of Health Sciences

Cabarrus College of Health Sciences is a robust educational institution that offers degrees in seven health science disciplines. The state-of-the-art campus is located on the grounds of Atrium Health Cabarrus where students learn in immersive healthcare environments.
Campbell University Clinical Research

Campbell University provides foundational and advanced knowledge of Clinical Research through its Bachelor’s and Master’s Degree programs. Our programs include study and application in product development, clinical trial operations, study design, data management, regulatory affairs, medical ethics, scientific writing, and biostatistical literacy. The curricula represents a combination of scholarly theory and real-world experience. Graduates are qualified to work as clinical investigators, clinical research associates, clinical research coordinators, data research coordinators, project support, project managers, data managers, safety specialists, regulatory managers, and other relevant positions.
Durham Tech Community College

Durham Tech offers a Clinical Trials Research Associate curriculum- accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP)- that includes its AAS degree and several certificate program offerings. Durham Tech’s AAS degree remains the only clinical research AAS program in the nation to achieve CAAHEP accreditation. The Clinical Trials Research program was established at Durham Tech in 1998 and has evolved with the growth of the industry to prepare students to assist physicians and clinical researchers in the initiation, administration, coordination, and management of clinical research studies for the development of new drugs, clinical products, and treatment regimens. The majority of the AAS degree program and all of the certificate programs can be completed through online or on-campus classes.
University of North Carolina Wilmington (UNCW)

UNCW offers multiple nationally ranked clinical research programs within the College of Health and Human Services. Students gain a broad understanding of the science, regulatory, and business aspects of developing new therapies whether they are new to the field, looking for a career change, or seeking career advancement. UNCW provides students flexible, online learning experiences to complete a Bachelor of Science in Clinical Research, Post-Baccalaureate Certification in Clinical Research Operations, or Master of Science in Clinical Research and Product Development. Also, UNCW provides the clinical research community: FuseCR and the Center for Clinical Research Workforce Development.
NC Central University (NCCU)

NCCU's Biomanufacturing Research Institute and Technology Enterprise (BRITE) offers students the knowledge and tools needed to function at a high level in clinical research positions in local and global industry.
Duke University

Duke is one of the largest biomedical research enterprises in the country, with nearly $798 million in sponsored research expenditures annually. The Duke University School of Medicine includes the research efforts of more than 2,500 basic science and clinical faculty members who strive to transform medicine and health, locally and globally, through innovative scientific research and rapid translation of breakthrough discoveries. Their research, which extends from the bench to the bedside, has resulted in some of the world’s most significant medical and biological discoveries and has resulted in innovative new treatments for a wide range of human diseases.
Wake Forest University

The Wake Forest University School of Medicine Office of Clinical Research focuses on protocol implementation, study coordination, data and regulatory management, clinical trial budget development, internal auditing and clinical trial education.
The University of North Carolina at Chapel Hill

The North Carolina Translational and Clinical Sciences Institute (TraCS) is the academic home of the NIH-funded Clinical and Translational Science Awards at UNC Chapel Hill. Through improving the efficiency of research, training the research workforce, and sharing successful research methods, TraCS supports its mission to accelerate clinical and translational research from health science to discovery to dissemination to patients and communities. TraCS partners with the UNC Network for Research Professionals in efforts to improve knowledge about clinical research careers. The network promotes excellence in the conduct of clinical, social, and translational research at UNC through a forum of education, professional development and mentoring programs.

Clinical Sites

Atrium Health

Atrium Health medical faculty, affiliated physicians, residents and fellows are involved in clinical research targeting specific illnesses, from cancer and emergency medicine, to pediatrics and surgery, and more.

Supporting Institutions

NCBIO

NCBIO is the trade association for the North Carolina life science industry. It’s members include clinical research organizations, pharmaceutical, biologics, and medical device companies, and other life science and supporting businesses.
North Carolina Biotechnology Center

The North Carolina Biotechnology Center is a private, nonprofit corporation that transforms North Carolina’s life science opportunities into economic prosperity through innovation, commercialization, education and business growth. NCBiotech fosters growth in the life sciences through funding, research services, and targeted initiatives in addition to economic development and recruitment activities.

Academic Programs: Clinical Research

Clinical research is an integral part of the CRO industry. Whether you are just getting started in field of clinical research, or want to expand your expertise, North Carolina's academic institutions have a number of programs that can help advance your career in this growing industry.

Cabarrus College of Health Sciences

Certificate

Cabarrus College of Health Sciences is a robust educational institution that offers degrees in seven health science disciplines. The state-of-the-art campus is located on the grounds of Atrium Health Cabarrus where students learn in immersive healthcare environments.
Campbell University Clinical Research

BS | MS

The Campbell University Clinical Research programs equip students with the knowledge and training to pursue careers as clinical researchers in the contract research organization industry. Campbell University offers a bachelors and masters of science in Clinical Research, as well as dual master degree programs.
Durham Technical Community College

Certificate | AAS

Durham Tech offers a Clinical Trials Research Associate curriculum- accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP)- that includes its AAS degree and several certificate program offerings. Durham Tech’s AAS degree remains the only clinical research AAS program in the nation to achieve CAAHEP accreditation. The Clinical Trials Research program was established at Durham Tech in 1998 and has evolved with the growth of the industry to prepare students to assist physicians and clinical researchers in the initiation, administration, coordination, and management of clinical research studies for the development of new drugs, clinical products, and treatment regimens. The majority of the AAS degree program and all of the certificate programs can be completed through online or on-campus classes.
Duke University

MS

Duke is one of the largest biomedical research enterprises in the country, with nearly $798 million in sponsored research expenditures annually. The Duke University School of Medicine includes the research efforts of more than 2,500 basic science and clinical faculty members who strive to transform medicine and health, locally and globally, through innovative scientific research and rapid translation of breakthrough discoveries. Their research, which extends from the bench to the bedside, has resulted in some of the world’s most significant medical and biological discoveries and has resulted in innovative new treatments for a wide range of human diseases.
Forsyth Technical Community College

Certificate

The Clinical Trials Certificate at Forsyth Technical Community College prepares individuals to assist with research studies in a variety of settings including medical centers, hospitals, pharmaceutical industries, clinics, research facilities, nanotechnology and biotechnology companies, and physicians’ offices. To enroll in this certificate program the student must have already completed a science or health related degree, certification, or license.
NC Central University (NCCU)

Certificate | BS

NCCU's Biomanufacturing Research Institute and Technology Enterprise (BRITE) offers students the knowledge and tools needed to function at a high level in clinical research positions in local and global industry.
University of North Carolina Wilmington (UNCW)

Certificate | BS | MS

UNCW offers multiple nationally ranked clinical research programs within the College of Health and Human Services. Students gain a broad understanding of the science, regulatory, and business aspects of developing new therapies whether they are new to the field, looking for a career change, or seeking career advancement. UNCW provides students flexible, online learning experiences to complete a Bachelor of Science in Clinical Research, Post-Baccalaureate Certification in Clinical Research Operations, or Master of Science in Clinical Research and Product Development. Also, UNCW provides the clinical research community: FuseCR and the Center for Clinical Research Workforce Development.
Wake Forest University

CRM

The Wake Forest University Master of Science in Clinical Research Management (CRM) program provides a holistic approach for students in clinical research. Designed for those working in or entering the clinical research field, this degree program expands participants’ knowledge of both the macro and micro aspects of the clinical research ecosystem and is focused on an overarching vision to shape and impact the future of healthcare.

Explore Careers in the CRO Industry

From foundational roles in clinical operations and research to biometrics and financial analysis, there are multiple ways to get started with a career in North Carolina's CRO industry. View the careers below to get more information on salary, on-the-job duties and educational requirements.

Job Title(s): Associate Biostatistician (Intern), Biostatistician I, Biostatistician II
Department: Biometrics, Health Economics & Outcomes
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Exempt and Salaried (Range $65,000–$86,000)

The Biostatistician is responsible for intermediate-level statistical analyses and programming for clinical trials
and/or research projects. The Biostatistician will provide statistical support for the production and review of both derived analysis
datasets and statistical outputs, and assist in the development of statistical analysis plans. This position will assist in trial design and data management review and consultation.

A Biostatistician II role requires elevated statistical programming skills, among others.

ESSENTIAL DUTIES
- Assist with the preparation of statistical analysis plans; independently generate descriptive and basic test statistics, analyze basic data requests, and generate statistical modeling results
- Contribute to the design and validation of analysis data sets, programs, and statistical output products (e.g., tables, listings, figures, etc.)
- Document analyses, create summaries/reports, and present results in written and verbal form
- Participate in most statistical aspects of a clinical trial/project, with consultation or assistance when needed
- Attend applicable internal project team meetings and teleconferences
- May design analysis data set specifications through writing own code, find errors, correct, and validate output and results
KNOWLEDGE, SKILLS and ABILITIES
- Familiarity with basic statistical methods that apply to Phase I-IV clinical trials
- High proficiency with full Microsoft applications; strong aptitude for SAS and/or SPSS programming skills preferred
- Strong spoken and written communication skills to include
- grammatical/technical writing; fluency in English
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Bachelor's degree in biostatistics and 2 years’ related experience/advanced education, or
- Master’s degree or PhD in biostatistics and 0–2 years’ related experience preferred
- Some clinical experience is required
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Biostatistician 2, biostatistician 3, senior biostatistician, principal biostatistician role
- Manager

Job Title(s): Clinical Research Associate, Clinical Research Associate I
Department: Clinical Operations
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Exempt and Salaried (Range $58,000–$89,000)

The Clinical Research Associate is responsible for assigned aspects of clinical monitoring and site management in accordance with applicable Standard Operating Procedures (SOPs) and the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of test subjects. The Clinical Research Associate represents the organization in a professional and collegial manner.

ESSENTIAL DUTIES
- Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials
- Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification, as required
- Ensure the integrity of data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPs
- Perform key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation
- Participate in audit preparation and follow-up activities, as needed
- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations
- Verify proper management and accountability of Investigational Product
- Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
- Manage essential documents as required by local regulations and ICH GCP before, during, and after a clinical study; assist with resolution of investigational site/data queries
KNOWLEDGE, SKILLS and ABILITIES
- General knowledge of regulatory requirements & GCP
- Ability to multi-task and deal with shifting priorities
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent
- 2 years’ experience in a clinical trials research environment required
- Valid driver’s license required
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 60% to 85%
CAREER PATHWAYS

Foundational role that leads to many others within CRO industry, including:
- Clinical research associate 2, senior/principal clinical research associate
- Clinical trial/team lead/manager (CTM); project management
- Quality control/quality analytics (QC/QA)
- Data analytics, data management, safety

Job Title(s): Clinical Research Coordinator, Clinical Research Specialist, Coordinator–Research, Clinical Studies Coordinator, Medical Research Associate
Department: Clinical Operations or Project Management
Organization Type: Contract Research Organization (CRO)-based and Site-based
Status/Salary: Exempt and Salaried or Non-Exempt and Hourly (Range $56,000–$85,000)

The Clinical Research Coordinator is responsible for the support and coordination of all aspects of clinical research including subject screening and recruitment, regulatory maintenance, data collection, and data management activities. These positions manage protocols to ensure the safety of patients and quality of clinical trial data.

Some Clinical Research Coordinator positions are more senior and may have increased responsibilities for patient care, protocol design, implementation, and training junior staff. These senior positions require additional experience and/or education.

ESSENTIAL DUTIES
- Develop or assist in the development of protocol-specific systems and documents including process flows, training manuals, and Standard Operating Procedures (SOPs); order supplies and equipment
- Recruit, screen, schedule, consent, and collect adverse events information for participants in a variety of studies; maintain documentation, including consent
- Perform technical procedures on clinical subjects under the direction of the principal investigator or their designee; collect, prepare, process, maintain, and ship collected samples
- Maintain appropriate patient records, as necessary, including charting the condition of the patient and determining their continued eligibility in the study
- Assist in providing patient education on the benefits and risks of participating in a clinical trial
- Assist with or develop data collection documents and instruments
- Review and document trends, problems encountered, patient adverse events, and subject progress
KNOWLEDGE, SKILLS and ABILITIES
- Understanding of medical terminology
- General knowledge of regulatory requirements & Good Clinical Practices (GCP)
- Data evaluation skills
- Ability to multi-task and deal with shifting priorities
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; extremely accurate and detail-oriented
EDUCATION and EXPERIENCE
- Associate’s degree in related field and 2 years’ experience in a medical and/or research setting, or
- Bachelor’s degree in related field and 0–1 year of experience in a medical and/or research setting
- Phlebotomy and/or venipuncture experience preferred
- Dual roles involving patient care may prefer a Bachelor of Science Degree in Nursing
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Clinical research coordinator 2, clinical research coordinator 3
- Clinical research associate path

Job Title(s): Research Technician, Clinical Research Technician
Department: Clinical Research Unit
Organization Type: Site-based
Status/Salary: Exempt and Hourly (Range $32,000–$58,500)

The Clinical Research Technician supports ongoing clinical research processes by following protocol requirements.

ESSENTIAL DUTIES
- Carry out major experimental protocol events, such as EKGs, phlebotomy, urine collection, standard measurements, vital signs, and blood pressures
- Set up and monitor data collection equipment
- Follow universal/standard precautions and maintain clean and safe work and subject areas; report unsafe work areas to appropriate leadership
- May serve as a lead worker
KNOWLEDGE, SKILLS and ABILITIES
- Knowledge of applicable laboratory procedures, tests, techniques, and terminology
- Ability to maintain the safety and wellbeing of participants at all times
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- High school diploma with 2 years’ clinical research experience, or
- Associate’s degree with no experience, or
- Bachelor’s degree preferred
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10% depending on protocol requirements
CAREER PATHWAYS

Foundational role that leads to many others within contract research organization (CRO) industry, including:
- In-house clinical research associate or clinical research associate
- Clinical research coordinator
- Data research coordinator
- Clinical research specialist

Job Title(s): Data Technician, Clinical Data Associate, Clinical Research Associate Assistant, Assistant Project Coordinator, Data Coordinator, Research Data Abstractor
Department: Biometrics, Clinical Research
Organization Type: Contract Research Organization (CRO)-based and Site-based
Status/Salary: Non-Exempt and Hourly (Range $40,000–$60,000)

The site-based Data Research Coordinator is responsible for clinical data review and query generation, resolution, and reconciliation to support the delivery of clinical data. Under general supervision, the position may also perform administrative and coordinative work directed toward the design, implementation, evaluation, and review of the assigned project(s).

ESSENTIAL DUTIES
- Enter study data into appropriate database and perform review of discrepancy output and validation listings
- Review and respond to queries to address problematic data identified during data review activities; apply proper correction/modification
- Apply quality control procedures and ensure data quality standards are achieved
- Create, update, track, and maintain study-specific trial management files, tools, and systems
- Maintain awareness of contract and scope of work for assigned project(s)
- Assist local team members with administrative activities as required, including filing, document maintenance, and ordering and maintaining adequate supplies for project
- Track site performance metrics (e.g., patient screening, enrollment, retention, etc.)
KNOWLEDGE, SKILLS and ABILITIES
- Knowledge of clinical data and Good Clinical Practices; knowledge of medical terminology
- High proficiency with full Microsoft applications; relational database management software systems experience
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Bachelor's degree in a life science-related field preferred
- 0–2 years’ experience in a data management, medical, and/or research setting
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Data manager
- Clinical research coordinator
- Project assistant

Job Title(s): Project Financial Analyst, Operations Financial Analyst
Department: Project Management, Clinical Operations, or Finance
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Exempt and Salaried (Range $47,500–$74,500)

The Financial Analyst contributes to the achievement of financial and project objectives through accurate and timely reporting of revenue and costs. The Financial Analyst prepares, reconciles, analyzes, and reports revenue, contracts, projects, and associated metrics for assigned projects and contracts. This position interfaces with management on requests for financial information and addressing compliance issues, while ensuring that all reporting activities are accurate and prepared within established timelines.

ESSENTIAL DUTIES
- Perform project analysis using different sources of information to support the financial decision-making process
- Identify and highlight potential issues related to project financial risks that impact profitability
- Monitor the overall health of assigned projects, including, but not limited to, revenues, gross profit, receivables, and unbilled amounts, as well as project close-outs and reconciliations
- Make appropriate recommendations that will positively impact operational effectiveness
- Prepare special reports and financial studies for management and provide findings and variances to plan
- Provide required financial reports within required deadlines, as requested
KNOWLEDGE, SKILLS and ABILITIES
- Solid understanding of accounting/financial principles and regulations/legal requirements
- Ability to handle sensitive information and make sound recommendations
- High proficiency with full Microsoft applications; proficiency with accounting software packages
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Bachelor’s degree or its international equivalent in accounting, finance, or business administration
- 0–2 years’ related experience
- Pharmaceutical or contract research organization (CRO) experience preferred
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Senior financial analyst
- Assistant project management
- Business proposals/contracts

Job Title(s): Remote Site Manager, In-house Clinical Research Associate, Central Monitoring Associate
Department: Clinical Operations
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Exempt and Salaried (Range $42,000–$65,000)

The In-house Clinical Research Associate is responsible for the assigned aspects of clinical monitoring and site
management that can be accomplished remotely in accordance with applicable Standard Operating Procedures (SOPs) and the
International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP).

ESSENTIAL DUTIES
- Liaise with management staff to ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring
- Collect documents, review data points/findings from electronic data capture (EDC) and file review
- Review and appropriately escalate site key risk/performance/quality indicators; provide trial status reports to project management, as required
- Write, follow, and resolve clinical queries and issues
- Assist with investigator recruitment activities utilizing phone scripts, questionnaires, study site materials, and other tools for evaluating investigative sites
- Document site management contacts according to the monitoring plan
- Assist in ensuring audit-ready files; contribute to company, client, and federal/local regulatory requirements/audit responses, as needed
KNOWLEDGE, SKILLS and ABILITIES
- General knowledge of regulatory requirements & GCP
- Ability to multi-task and deal with shifting priorities
- Data evaluation skills
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; highly accurate and detail-oriented
EDUCATION and EXPERIENCE
- Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent
- 1+ year of experience in clinical research trial environment preferred
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS

Foundational role that leads to many others within CRO industry, including:
- Clinical research associate pathway
- Data management
- Site start-up

Job Title(s): Consultant Nurse, Nurse
Department: Medical Communications, PVG (pharmacovigilance)
Organization Type: Contract Research Organization (CRO)-based or Site-based
Status/Salary: Exempt and Salaried or 1099 Consultant (Range $53,500–$86,500)

The Nurse Consultant is a full-time role that provides expert medical information that is delivered with a high level of customer service to a variety of audiences, both internal and external.

ESSENTIAL DUTIES
- Research and respond to inquiries and documents according to applicable guidelines
- Identify and record adverse events and product complaints, and provide clinical trial information
- May provide technical expertise and guidance in assessing, developing, and implementing educational research
- Provide after-hours on-call support, as needed (e.g., on-call pager coverage)
KNOWLEDGE, SKILLS and ABILITIES
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of policies and procedures including client products, Standard Operating Procedures, protocols, Good Clinical Practices, and all applicable regulatory requirements
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Associate’s degree and Nursing Diploma plus 2 years’ nursing experience, or
- Bachelor of Science in Nursing plus 0 to 2 years’ nursing experience
- Possession of a current North Carolina license to practice as a registered nurse (RN)
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Medical science liaison, pharmacovigilance, quality assurance/quality control, regulatory
- Study start-up

Job Title(s): Project Coordinator, Project Associate, Program Assistant, Project Specialist, Clinical Trial Assistant
Department: Clinical Operations
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Exempt and Hourly (Range $38,500–$58,000)

The Project Assistant and Clinical Trial Assistant are junior roles responsible for administrative tasks—both simple and complex—in support of project or department goals. These positions work with team members to ensure that projects and assignments are completed in accordance with contract, customer, and/or organizational expectations.

Project Coordinators, Associates, and Specialists are more senior positions that assume additional responsibilities such as Trial Master File updates and overall document and regulatory management. These positions may also train junior staff and have increased responsibilities for project team support in the areas of initiation, planning, execution, control, and/or closure.

ESSENTIAL DUTIES
- Responsible for the coordination and completion of simple and complex administrative tasks in support of project or department management, such as file creation and maintenance, phone coverage, and the creation of status reports, presentations, and graphics
- Coordinate, attend, and participate in project meetings; prepare and distribute meeting minutes and action items
- Regularly facilitate team communication and liaise with sponsors, investigate sites, and third-party contractors, as requested
- May update or coordinate updates to Trial Master File
- May provide support for quality assurance activities, including preparation for audits and internal review, preparation of documentation, and resolution on actionable issues
- May create and track budgets, and assist in the preparation of work order requests
KNOWLEDGE, SKILLS and ABILITIES
- High proficiency with full Microsoft applications
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Associate’s degree in related field and 2 years’ experience in a medical and/or research setting, or
- Bachelor’s degree in related field and 0–1 year of experience in a medical and/or research setting
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Project management
- In-house clinical research associate (CRA) > CRA pathway
- Remote monitor
- Clinical research coordinator
- Regulatory specialist

Job Title(s): Safety Assistant, Drug Safety Assistant, Safety Data Coordinator
Department: Safety
Organization Type: Contract Research Organization (CRO)-based
Status/Salary: Non-Exempt and Hourly (Range $47,500–$73,500)

The Safety Assistant performs a variety of safety monitoring duties within the department. Responsible for assisting with the smooth function of the pharmacovigilance department to ensure all adverse events are processed to the required standard and submitted to the client and regulatory agencies (if applicable) within agreed upon timelines. The Safety Assistant must adhere to all data protection guidelines, the Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures.

ESSENTIAL DUTIES
- Manage all adverse event and endpoint source documentation in accordance with Standard Operating Procedure (SOP) specifications; escalate issues to management, as needed
- Scan received documents for unrequested personal identifiers and initiates appropriate actions to protect data privacy
- Perform file creation, tracking, retention, and maintenance—both paper and electronic; maintain industry reference documentation
- Assist in the preparation of safety-related meetings and prepare minutes
- Provide simple and complex administrative support, such as the appropriate distribution of incoming paperwork/inquiries and assisting in production of queries of safety data for clients
KNOWLEDGE, SKILLS and ABILITIES
- Medical terminology knowledge strongly preferred
- Ability to multi-task and deal with shifting priorities
- High proficiency with full Microsoft applications; database experience
- Strong spoken and written communication skills; fluency in English
- Strong interpersonal, collaborative, and time management abilities
- Excellent organizational skills; accurate and detail-oriented
EDUCATION and EXPERIENCE
- Associate’s Degree in Nursing plus 1-2 years’ experience, or
- Bachelor’s degree in a life science-related field and 1+ year of related safety experience preferred
TRAVEL and PHYSICAL REQUIREMENTS
- Travel can range from 0 to 10%
CAREER PATHWAYS
- Safety manager 1 > safety manager 2 > senior safety manager
- Regulatory, post-marketing surveillance

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Find Your Element

There are hundreds of reasons a career in clinical research will help you find your element. Learn why clinical research is a great career choice, hear from professionals in the field, and sign up for more information about careers in clinical research on the Find Your Element website.

About the Find Your Element Campaign

Thanks to the support of the ACRP Partners in Workforce Advancement, the Association of Clinical Research Professionals launched ‘Find Your Element’ to help raise awareness of the clinical research profession among college students.

Chimerix’s Potential Smallpox Therapy Gains FDA Priority Review

Chimerix, a Durham-based biopharmaceutical company that’s developing medicines to treat cancer and other diseases, has received good regulatory news for its potential antiviral treatment for smallpox.

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December 8, 2020

Syneos Bolsters Contract Research Reach With $400M Synteract Buyout

Syneos Health, one of the biggest contract service providers in the sector is getting even bigger through the acquisition of Synteract.

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October 30, 2020

Grifols Produces First Batches of Potential COVID-19 Therapeutic for Testing

Grifols, a global biotherapeutics company with major operations in North Carolina, has delivered the first batches of a therapeutic product manufactured in Clayton that could help prevent and treat COVID-19 infection.

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July 31, 2020

IQVIA Initiative Gives COVID-19 Researchers Free Access to Global Data

RTP-based contract research giant IQVIA has launched a program that waives licensing and access fees for approved academic researchers as part of its efforts to accelerate research on how COVID-19 is impacting the healthcare industry and related treatment.

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July 28, 2020

Avior Bio Launches Clinical Trial of Chronic Itch Therapy

Less than two years after launching, Avior Bio is kicking off its first human trial for a novel drug therapy treating pruritus, or chronic itchy skin

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July 27, 2020

Grifols Begins Producing First COVID-19 Drug in Clayton

Grifols, a global biotherapeutics company with major operations in North Carolina, has begun producing the first specific COVID-19 drug at its manufacturing campus in Clayton.

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June 11, 2020

Collaborations Pharmaceuticals, Built Around Collaborations, Now Targets COVID-19

Raleigh's Collaborations Pharmaceuticals is partnering with universities, foundations and other companies to develop drugs that treat rare and neglected diseases, but it's also targeting COVID-19 now.

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June 10, 2020

Q2 Solutions Partnership Deal Will Make Oncology Clinical Trial Enrollments Faster

Morrisville's Q2 Solutions has inked a partnership deal with Thermo Fisher Scientific tol speed up enrollment of patients in oncology clinical trials.

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June 3, 2020

LabCorp Helps People Connect with COVID-19 Research Trials

If you’re interested in participating in a clinical trial to solve some of the riddles of COVID-19, LabCorp can help you make that connection.

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June 2, 2020

Durham-based IQVIA to Manage Clinical Trial of Hydroxychloroquine Vs. COVID-19

Durham-based IQVIA is managing an Australian clinical study of hydroxychloroquin to prevent a COVID-19 infection

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May 21, 2020

For more information, contact:

Vivian W. Doelling, Ph.D.
Vice President, Emerging Company Development
Emerging Company Development
919-549-8859 | vivian_doelling@ncbiotech.org

Laura Rowley, Ph.D.
Director, Life Science Economic Development
Life Science Economic Development
919-549-8864 | laura_rowley@ncbiotech.org

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