Clinical Research Coordinator
Durham, NC, US, 27710
Be You. Be Bold. Choose Duke.
Clinical Research Coordinator II
Be You.
Be Bold.
What You'll Do:
Lead Research Operations
- Coordinate day-to-day activities for clinical research studies, including studies involving greater than minimal risk and complex interventions.
- Manage all aspects of investigational products, including receipt, storage, tracking, accountability, and participant dispensing.
- Serve as a primary liaison among sponsors, investigators, regulatory offices, research support services, and study teams.
- Prepare and maintain study documentation, regulatory files, standard operating procedures, and protocol submissions.
- Support study monitoring visits, audits, inspections, and closeout activities while addressing findings and implementing corrective actions.
- Coordinate participant recruitment, screening, enrollment, retention, and study visit activities.
- Collect, process, maintain, and ship research specimens according to protocol and regulatory requirements.
Advance Participant Safety and Research Ethics
- Conduct informed consent discussions and documentation for a wide range of research studies.
- Collaborate with investigators to identify, evaluate, document, and report adverse events and safety concerns.
- Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports.
- Ensure adherence to ethical principles, clinical research regulations, Duke policies, and participant protections.
- Educate participants regarding study procedures, risks, benefits, and distinctions between clinical care and research activities.
Support High-Quality Data Management
- Collect, enter, validate, and maintain research data using approved systems and procedures.
- Ensure data quality, completeness, accuracy, and regulatory compliance.
- Develop tools, workflows, and processes that improve data collection and quality assurance.
- Support data lifecycle management, data sharing activities, open science initiatives, and repository submissions.
- Create reports, dashboards, summaries, visualizations, and study metrics that support informed decision-making.
- Utilize research technologies and statistical tools to assist with quantitative and qualitative analyses.
Contribute to Scientific Discovery
- Conduct literature reviews and support development of research protocols and funding proposals.
- Assist with scientific presentations, posters, manuscripts, and dissemination of research findings.
- Apply knowledge of research methodology and study design to support successful study execution.
- Collaborate across disciplines to advance clinical and translational research initiatives.
Drive Study and Site Excellence
- Utilize clinical research systems, electronic health records, OnCore, eREG, and related platforms to manage study activities.
- Assess study feasibility and support operational planning efforts.
- Coordinate study resources, supplies, equipment, and participant scheduling.
- Ensure studies are conducted according to protocol, institutional requirements, sponsor expectations, and regulatory guidelines.
- Prepare studies for completion, closeout, and long-term document retention.
Grow as a Research Professional
- Provide guidance, training, and support to less experienced research staff as appropriate.
- Participate in professional development opportunities, research education programs, and institutional initiatives.
- Stay informed of emerging clinical research regulations, best practices, and industry developments.
- Foster collaborative relationships while demonstrating adaptability, accountability, and strong organizational awareness.
What You'll Bring:
Education
- Associate's degree required.
Experience
- Minimum of two years of relevant clinical research experience.
- Completion of the DOCR North Carolina State-Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
Knowledge, Skills & Abilities
- Knowledge of clinical research principles, regulatory requirements, and Good Clinical Practice (GCP).
- Ability to manage multiple priorities in a dynamic research environment.
- Strong organization, communication, problem-solving, and collaboration skills.
- Experience with electronic research systems, data management platforms, and Microsoft Office applications.
- Ability to maintain confidentiality and uphold ethical research standards.
Choose Duke.
Ready to Make a Difference?
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.
Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh