Clinical Research Coordinator
Department of Obstetrics & Gynecology-Division of Urogynecology
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine, Division of Urogynecology; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff.
Clinical Research Operations:
- Screen participants for all studies independently. Maintain subject level documentation for all studies independently. Schedule participants and conduct visits for all studies independently.
- Train others to conduct and document visits and protocol-specific testing/interviews.
- Assist with development and follow procedures and documentation of study payment in timely fashion.
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
- Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
- Conduct and document consent for participants in a variety of studies independently
- Prepare for study monitoring and study audit visits.
- Collect, prepare or process adverse event information independently. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision.
- Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Ethical and participant safety considerations:
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications. Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction.
- Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.
- Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
- Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
- Train others on study team in use of technologies and software, and in completion of ECRFs.
- Assist with the development of data collection documents to standardize process.
- Use EDC systems and enter data accurately.
- Use required processes, policies, and systems to ensure data security and provenance.
- Recognize and report vulnerabilities related to security of physical and electronic data.
- Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
- Run summaries and reports on existing data Follow SOPs for data QA. Recognize when data agreements are necessary
Study and Site Management:
- Collect information to determine appropriate feasibility, recruitment and retention strategies.
- Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.).
- Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
- Take part in site initiation/closeout visits as directed.
- Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
- Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
- Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate.
- Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Requisition Number 401482753
Duke Entity MEDICAL CENTER
Job Code 1201 CLINICAL RESEARCH COORDINATOR
Job Family Level 52
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
- Completion of a Bachelor's degree..
- Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).
Computer skills such as Microsoft Excel and Microsoft Word. MAESTROCare/EPIC experience preferred. Prior research experience and/or training related to health science/clinical research with OBGYN experience preferred.
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