Duties: The primary role of Clinical Research Nurse Coordinator is the organization, coordination and implementation of Phase I-IV clinical research trials. The essential functions of the position include but are not limited to: Participate in the review and preparation of protocols for original, pharmaceutical and government sponsored clinical trials. Assist in the preparation of regulatory documentation as required for amendments, continuing reviews, and adverse event reporting.
Organize and participate in site visits, both initiation and otherwise. Attend Investigator meetings for Clinical Research Trials if necessary. Be actively involved in planning and implementation of patient recruitment into studies. Review patient charts and evaluate as potential candidates for various studies as requested. Discuss identified participants with investigator and the need for necessary baseline exams. Coordinate scheduling of trial participants visits with study investigators and nurse practitioners as per protocol. Provide clinical services, including phlebotomy and vital sign assessment at time of participant screening visits and when necessary. Provide oversight of administration of medications, study drugs, or study interventions, as appropriate. Provide oversight and coordination of radiographic imaging and laboratory findings. Conduct assessment and collect medical history. Monitor patient care, assess patient status, and monitor treatment side effects. Coordinate scheduling of trial participants visits with study investigators and nurse practitioners as per protocol. Plan, direct, and assess overall study management of patient in collaboration with investigator. Intercept and respond to trial participants phone calls. Perform telephone follow-up per study protocol.
Responsible for data collection and management in accordance with trial protocol. Responsible for maintenance of source documents and case report forms. Collect and report timely, valid accurate data, maintain individual patient records. Maintain study compliance and integrity through close collaboration with investigator as well as the patient. Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups. Process and ship blood, urine and serum specimens for each trial. Obtain diagnostic materials such as slides from pathology and/or scans from radiology and ship to sponsor/independent review per protocol guidelines.
Attend investigator and site initiation meetings. 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. Work independently under limited supervision, and together with team members. Report directly to Director of Clinical Research Operations.

Qualifications: Registered Nurse, current PA license without restriction or limitation and 1 year of experience required. BSN degree preferred. Position prefers an articulate individual with a strong background in women's health and patient education. 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 work flexible hours. Must be able to communicate comfortably and effectively with regulatory authorities/sponsors/investigators; knowledge of IRB and human research protection regulations, preferred. Requires strong attention to detail in composing and proofing written materials for scientific publication..

Reference Number: 40-26419

Salary Grade: 026

Employment Type: Exempt

Org: WM-Ctr for Res on Reprod and Women's Health

Special Requirements:

Job Family: J-Technical/Professional Medicine/Health

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