CLINICAL RESEARCH NURSE COORDINATOR
CLINICAL RESEARCH NURSE COORDINATOR
Participate in 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, and documentation, of clinical research data.
1.Clinical research operations. Screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. 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.
Provide IV therapy as described in study protocol.
Participate in care (both clinically and research related) of medically high-risk patients
Collect, prepare, process, ship, and maintain inventory of research specimens.
Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.
Provide input for Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.
Collect, prepare, or process adverse event information per protocol. May complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
2.Ethical and participant safety considerations. Maintain familiarity 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.
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. May recognize when patients are having difficulties with this distinction.
3.Data management and informatics. Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Enter data accurately. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance.
Use required processes, policies, and systems to ensure data security and data provenance.
Study and site management. Participate in sponsor-required training.
Ensure participant care expenses have appropriate financial routing in a timely manner.
Prepare for, take part in monitoring and closeout visits and document storage activities. Collect information to determine 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.).
Maintain Delegation of Authority log.
1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level
Full Time / Part Time
Regular / Temporary
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 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.
Work requires graduation from an accredited BSN or Associate's Degree in Nursing 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 two years of their start date and to complete the program within five years of their start date. Experience: Twelve months of appropriate clinical experience is required.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Auto req ID
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.