Clinical Research Coordinator

Clinical Research Coordinator

Participates in or leads day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Operations:
Screen participants for all studies independently. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.

Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. 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 Assist with addressing and correcting findings from study monitoring and study audit visits.

Collect, prepare or process adverse event information under supervision. 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. Ethics:
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. 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 Leadership:
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

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.

Take part in or lead closeout and document storage activities Communication:
Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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.

Knowledge,

Skills and Abilities

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers). Level Characteristics Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers). Preferred Qualifications Bachelors Degree in biology, zoology, any closely related degree. Minimum Qualifications Education Completion of an Associate's degree Experience Work requires a minimum of two years of relevant research experience.

Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. Degrees, Licensures, Certifications Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research…