Clinical Research Coordinator A/B

The University of Pennsylvania is hiring a Clinical Research Coordinator A/B to coordinate clinical trials and patient-oriented research. The role manages study operations, regulatory documentation, participant enrollment and follow-up, data and sample handling, and compliance with clinical research requirements.

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

Other duties and responsibilities as assigned

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

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 for eligible health care and dependent care expenses with pre-tax dollars.

Tuition assistance for you, your spouse, and your dependent children at Penn; dependent children are also eligible for tuition assistance at other institutions.

Basic, Matching, and Supplemental retirement plans, with pre-tax or Roth savings and investment options through TIAA and Vanguard.

A substantial amount of time away from work during the course of the year.

Long-term care insurance for faculty and staff and eligible family members. If you apply when newly hired, you will not have to provide proof of good health or be subject to underwriting requirements; eligible family members must provide proof of good health and are subject to underwriting.

Wellness and work-life programs and resources to support health, family, and work-life balance.

Resources to advance personally and professionally.

Access to University libraries, athletic facilities, arboretum, art galleries, and cultural and recreational activities; many activities are free for you and your family.

Discounts and special services, including free and discounted admission and memberships at Penn arts and cultural centers and museums, and savings on other goods and services such as cars, cellular phone plans, movie tickets, and theme park admission.

Flexible work options involving 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, usable for closing costs or home improvements.

Reimbursement for eligible employees’ qualified legal adoption expenses, such as travel or court fees, for up to two adoptions in your household.

Company

Ivy League university offering undergraduate and graduate education

Philadelphia, Pennsylvania, USA

http://www.upenn.edu/

Founded in 1740

10001+ employees

Qualifications

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required

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

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

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

Required skills

Represents the skills you have, click on the tags, Bachelor of Science

Experience

1+ years