Clinical Research Specialist, Sr
Durham, NC, US, 27710
Be You. Be Bold. Choose Duke.
Clinical Research Coordinator I
Be You.
Be Bold.
What You'll Do
Research Operations
- Assist with managing investigational products, including receipt, storage, handling, inventory management, and reordering activities.
- Support study monitoring visits, sponsor audits, and regulatory reviews.
- Recruit and retain research participants according to study protocols and established procedures.
- Screen potential participants in person, by phone, or through record review for eligibility determination in non-complex studies.
- Collect participant information and maintain study documentation in accordance with study requirements.
- Schedule participant visits and coordinate study activities.
- Prepare study materials, supplies, equipment, and documentation required for participant visits.
- Conduct and document non-complex research visits, interviews, questionnaires, and scripted assessments.
- Collect, process, prepare, ship, and maintain inventories of research specimens.
- Manage participant reimbursement activities when required.
- Participate in study team meetings and provide operational support throughout the study lifecycle.
Research Ethics & Regulatory Compliance
- Recognize and report protocol-defined adverse events and participant safety concerns to the study team.
- Conduct and document informed consent processes for minimal-risk and non-complex studies.
- Assist with development and maintenance of participant consent documents and consent plans.
- Support preparation and submission of regulatory documentation to the Institutional Review Board (IRB).
- Adhere to Good Clinical Practice (GCP), institutional policies, and study-specific standard operating procedures.
- Support ongoing regulatory compliance activities and audit readiness.
Data Management & Quality Assurance
- Collect, enter, review, and maintain research data for assigned studies.
- Correct and document incomplete, inaccurate, or missing data according to study procedures.
- Perform quality assurance activities to ensure data integrity and protocol compliance.
- Run data summaries and reports to support investigators and study teams.
- Follow established processes to ensure data security, privacy, and regulatory compliance.
- Identify and report vulnerabilities related to research data security.
- Support data sharing initiatives and repository submissions in accordance with sponsor and institutional requirements.
- Utilize research data standards and controlled terminology when applicable.
- Learn and use research databases, software applications, and emerging technologies.
- Assist with dataset management activities including merging datasets, recoding variables, and managing scoring scales.
- Support development of study reports, data visualizations, participant summaries, and progress updates.
- Assist with system testing, validation activities, and electronic research system enhancements.
Scientific Support
- Conduct literature reviews and research-related information gathering.
- Assist investigators and study teams with development of study protocols for registries, survey studies, and other straightforward research projects.
- Support preparation of research presentations, abstracts, posters, publications, and dissemination efforts.
- Contribute to the communication of research findings to stakeholders and participants.
Study & Site Management
- Coordinate or schedule study-related meetings and site visits.
- Maintain study records, protocol documentation, and participant accrual information within clinical research management systems.
- Ensure study supplies and equipment are available, maintained, and functioning properly.
- Follow protocol-specific workflows and operational processes.
- Assist with study startup and study closeout activities, including records management, storage preparation, and return of study materials to sponsors when applicable.
- Support ongoing study organization and documentation activities to ensure operational readiness.
Professional Development & Collaboration
- Partner with supervisors and research leaders to identify development opportunities and create individualized learning plans.
- Participate in educational programs, training activities, and professional development opportunities.
- Apply newly acquired skills and knowledge to research operations.
- Share knowledge and assist with training colleagues when appropriate.
- Stay current with clinical research regulations, best practices, and emerging technologies.
- Attend departmental meetings, research forums, and educational sessions.
- Collaborate effectively with investigators, sponsors, research staff, and multidisciplinary teams to support successful study implementation and problem resolution.
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Choose Duke.
At Duke, you'll find more than a job. You'll join one of the nation's leading academic research institutions, where innovation, discovery, and collaboration drive meaningful change. Duke's clinical research enterprise is committed to advancing knowledge, improving patient outcomes, and shaping the future of medicine.As a Clinical Research Coordinator I, you'll support research that improves lives while building expertise in clinical operations, regulatory compliance, participant engagement, and data quality. Whether you're beginning your research career or expanding your experience, Duke offers opportunities for professional growth, mentorship, and meaningful work that makes a difference.Minimum Qualifications
Education
Work requires an Associate's degree.Experience
One year of relevant experience.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $23.00 to USD $34.50. 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 goes beyond 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 on collaboration, 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