Clinical Research Coordinator A/B (Department of Rehabilitation Medicine)

University of Pennsylvania Perelman School of Medicine•Cherry Hill, AR

22h•Onsite

About The Position

This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.

Requirements

Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required (for Clinical Research Coordinator A).
Bachelor of Science and 2 to 4 years of experience or equivalent combination of education and experience is required (for Clinical Research Coordinator B).

Responsibilities

Assist in the management of multiple clinical trials and responsibilities in specific research area.
Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data.
Assist with Institutional Review Board (IRB) filings and inquiries.
Assist in the preparation of manuscripts, grant proposals, and research related presentations.
Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions.
Implement approved changes to procedures as needed and monitor results.
Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.
Prepare and process all Institutional Review Board (IRB) submissions through the IRB and other regulatory groups as appropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events.
Coordinate, organize and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders).
Assist in the coordination of Phase I-IV clinical trials.
Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required.
Schedule patient visits and any necessary testing.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Process and ship blood, urine and tissue as required per trial.
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation.
Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies.
Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions.
Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures.
Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests).
Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events.
Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up.
Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC).
Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow.
Other duties and responsibilities as assigned.

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition assistance for employees, spouse, and dependent children at Penn.
Tuition assistance for dependent children at other institutions.
Generous retirement plans (Basic, Matching, and Supplemental) to save for your future on a pre-tax or Roth basis, with a wide variety of investment options through TIAA and Vanguard.
Substantial amount of time away from work (vacations, personal affairs, illness or injury, family time).
Long-term care insurance (in partnership with Genworth Financial) for faculty and staff (and eligible family members).
Wide variety of programs and resources to help care for your health, your family, and your work-life balance (Wellness and Work-life Resources).
Array of resources to help you advance yourself personally and professionally (Professional and Personal Development).
Access to a wide range of University resources, cultural and recreational activities (libraries, athletic facilities, arboretum, art galleries, Penn Museum, Annenberg Center, Penn Relays).
Discounts and special services (arts and entertainment, transportation, mortgages, new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks).
Flexible work options for non-traditional work hours, locations, and/or job structures.
Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia (Penn Home Ownership Services).
Reimbursement for qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions (Adoption Assistance).