Regulatory Affairs Specialist

Inside Higher Ed

Philadelphia (Philadelphia County)

On-site

USD 50,684 - 91,232

Full time

14 days+

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Job summary

A leading educational organization is seeking a Regulatory Affairs Specialist in Philadelphia. This role involves coordinating regulatory documentation for clinical trials, resolving queries, and supporting study teams. Ideal candidates will have a Bachelor's degree, 3-5 years of experience, and strong communication skills. The position offers a salary range of $50,684 to $91,232 annually.

Qualifications

3-5 years of related experience or equivalent.
Ability to work independently and as part of a team.
Demonstrated flexibility and multi-tasking abilities.

Responsibilities

Prepare and process regulatory documentation for clinical trials.
Resolve regulatory and data queries as required.
Participate in study team meetings and compliance training.

Skills

Effective problem solving

Effective communication

Organizational skills

Time management skills

Teamwork

Knowledge of IRB regulations

Education

Bachelor's degree

Job description

Overview

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The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 13 Research Teams that support disease/discipline specific cancer programs within the ACC.

Job Description

The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Specialist to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close-out visits. He/she will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist is expected to facilitate the development of investigator-initiated research protocols, the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to facilitate direct regulatory/compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site trials.

Qualifications

Bachelor's degree and 3-5 years of related experience or an equivalent combination of education and experience required. 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.

Job Location

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$50,684.00 - $91,232.00

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements

Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

To apply

To apply, visit the listing at the provided job site.

Note

Seniority level