Clinical Research Coordinator B-Regulatory (Department of Radiation Oncology)

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and 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, and much more.

Posted Job Title

Clinical Research Coordinator B-Regulatory (Department of Radiation Oncology)

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

The primary role of the Clinical Research Coordinator B (Regulatory Coordinator) is to assist with regulatory needs and ensure compliance of the Department of Radiation Oncology’s portfolio of clinical trials and research studies with University of Pennsylvania, FDA, GCP, and other sponsor, federal, state, and local regulations and guidelines.
Position is contingent upon funding.

Job Description

Job Responsibilities

• Assist the Regulatory Affairs Specialist in preparing, submitting, and processing approvals from the IRB and other Penn review entities for new research studies as well as for continuing reviews, modifications, reportable events, and study closures throughout the life of a study

• Under supervision, prepare, submit, and process approvals of Confidential Disclosure Agreements, Data Use Agreements, and other agreements between Penn’s legal office and external entities

• Participate in resolution of regulatory-related queries for Site Initiation Visits, audits and monitoring visits, Close-Out Visits, and as needed with Penn entities, industry sponsors, and external institution coordinating centers

• Assist the Regulatory Affairs Specialist in managing sites for the department’s multi-site trials by tracking essential documents, personnel credentials, and institution credentials from the sites

• Assist with registering and updating study records in Penn’s Clinical Research Management System (CRMS) and in departmental online portals such as SharePoint

• Assist with setting up and maintaining regulatory files in the departmental Shared Drive, study e-regulatory binders in PennVault, and in physical binders

• Attend CRU weekly team meetings and other meetings as required

• Administrative duties will include but are not limited to: maintaining the CRU’s weekly team meeting training log and taking meeting minutes; ordering and tracking office supplies; tracking the department’s personnel credentials (CVs, licenses, CITI trainings) and institution credentials (lab certificates, etc.); coordinate the CRU’s submissions to the department’s quarterly newsletter; assist the Regulatory Affair Specialists in creating and updating the CRU’s guidance and administrative documents; and assist the Regulatory Affairs Specialist in planning regulatory trainings and events for the team.

• Other duties and responsibilities as assigned

Qualifications

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

Preferred

• Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

This position is hybrid eligible after successful completion of intro period and 6 months of service.

Position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania