Clinical Research Coordinator A/B

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

110d•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

CRC-A Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
CRC-B Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Position is contingent upon continued funding.

Responsibilities

CRC-B 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
Other duties and responsibilities as assigned
CRC-A 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

Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.