CLINICAL RESEARCH NURSE COORDINATOR
CLINICAL RESEARCH NURSE COORDINATOR
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff.
- 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.
- 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 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. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA. Recognize when data agreements are necessary
- 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.
- Collect information to determine appropriate feasibility, recruitment and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. 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 and closeout meetings independently Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Coordinate operational plans for multiple research studies. Take part in or lead closeout and document storage activities
- 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.
1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, genderidentity, national origin, race, religion, sexual orientation, orveteran status.*******************************************************Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires graduation from an accredited BSN or Associate's Degree inNursing or Nursing Diploma program.All registered nurses without a Bachelor's degree in Nursing (or higher)will be required to enroll in an appropriate BSN program within twoyears of their start date and to complete the program within five yearsof their start date.Experience: Twelve months of appropriate clinical experience isrequired.
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.