CLINICAL RESEARCH NURSE
Duties: The main role of the position will be to operationalize, oversee and participate in the clinical trials that are part of the MFMU network. Duties for this role include but are not limited to:
1) Participating in the review and preparation of protocols for original and government clinical trials
2) Regulatory involvement: preparing and processing all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting; collect and report timely, valid accurate data, maintain individual patient records
3) Traveling to and attending meetings for the MFMU network at NIH. Duties including preparing statistics for each study and presenting them at these meetings.
4) Be responsible for registering and maintaining clinicaltrials.gov site for all interventional trials
5) Recruitment and retention: Interview and evaluate participants as potential candidates for various studies enrollment. Coordinate scheduling of trial participants visits with study investigators and clinical research coordinators as per protocol. Provide clinical services, including phlebotomy and pelvic exams at time of participant visits and when necessary. Provide oversight of administration of medications, study drugs, or study interventions, as appropriate.
6) Nursing duties: It is expected that the nurse will be able to perform routine obstetrical procedures such as phlebotomy, pelvic exams, and basic sonogram. (Teaching of these duties can be done if there is not proficiency)
7) Data abstraction and quality: Overall data quality will be the responsibility of the research nurse. Responsible for data collection and management in accordance with trial protocol. Responsible for maintenance of source documents and case report forms.
8) Collaboration with MCHRP research team. Plan, direct, and assess overall study management of patient in collaboration with providers and clinical research coordinators. Intercept and respond to trial participants phone calls. Perform telephone follow-up per study protocol.
9) Maintain study compliance and integrity through close collaboration with investigators and clinical research coordinators as well as the patient. Participate in the conduct of audits by study sponsors, the FDA, and other groups. Adhere to all University of Pennsylvania, Informed Consent Form (ICF), and FDA guidelines. Provide ongoing service education updates to all investigators and HUP staff that have eligible participants for clinical research studies.
Position is contingent on continued funding.
Qualifications: Registered Nurse, current PA license required and 2-3 years of clinical experience required. BSN degree preferred. Prior clinical research experience is considered favorable. Position prefers an articulate individual with a strong background in women's health. Must possess excellent oral and written communication skills as well as the ability to work independently and also as part of a team. Strong planning and organizational capabilities along with problem solving skills desired. Must be able to communicate comfortably and effectively with regulatory authorities/sponsors/investigators; knowledge of IRB and human research protection regulations, preferred.
Must be able to work flexible hours
Reference Number: 40-25889
Salary Grade: 027
Employment Type: Exempt
Org: WM-Ctr for Res on Reprod and Women's Health
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: J-Technical/Professional Medicine/Health