Clinical Research Coordinator
OBGYN-Division of Maternal-Fetal Medicine Clinical Research Coordinator
- Screen participants for all studies independently. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. May conduct study visits independently.
- Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Describe the various steps involved in handling IP.
- Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering 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. Evaluate processes to identify issues related to recruitment and retention rates.
- Conduct and document consent for participants in a variety of studies independently.
- Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently.
- Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications.
- 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. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
- Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role.
- Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. 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.
- Leadership: Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.
Study and Site Management:
- Take part in site initiation/closeout visits as directed. Take part in or lead closeout and document storage activities Communication: 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.
Type of Research
- This position will involve the recruitment of pregnant women for various clinical research studies across the health system both in the clinical and inpatient settings.
- These studies primarily follow women through their pregnancy, delivery and postpartum and involve a wide range of observational and interventional aims.