Clinical Research Coordinator A/B

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

9d•$47,313 - $56,275•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. This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors coordinators and research assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multisite trials.

Requirements

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required. (for CRC-A)
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. (for CRC-B)

Responsibilities

Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
Oversee study preparation and blood sample processing and analysis
Database management and analysis
Ordering and stocking supplies, maintaining equipment
Educate patients and family members
Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
Prepare and process all Institutional Review Board (IRB)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

excellent healthcare
tuition benefits for employees and their families
generous retirement benefits
wide variety of professional development opportunities
supportive work and family benefits
wealth of health and wellness programs and resources
comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
flexible spending accounts
tuition assistance here at Penn for employee, spouse, and dependent children
tuition assistance at other institutions for dependent children
generous retirement plans
pre-tax or Roth basis retirement savings
substantial amount of time away from work
long-term care insurance
wellness and work-life resources
professional and personal development resources
access to a wide range of University resources as well as cultural and recreational activities
free or discounted admission and memberships to University arts and cultural centers and museums
substantial savings on other goods and services
flexible work options
forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
adoption assistance