Clinical Research Coordinator B

University of Pennsylvania

1d•Onsite

About The Position

Manages phases of complex clinical trials under general supervision, ensuring compliance with good clinical practice. Oversees study operations, mentors junior staff, and contributes to budget preparation and expense management for multi-center trials. Coordinates with partnering institutions, supports monitoring of external sites, and participates in study and protocol training meetings.

Requirements

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Responsibilities

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
a wide variety of professional development opportunities
supportive work and family benefits
a wealth of health and wellness programs and resources
Health, Life, and Flexible Spending Accounts
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
Retirement plans
Time Away from Work
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development
University Resources
Discounts and Special Services
Flexible Work Hours
Penn Home Ownership Services
Adoption Assistance