Clinical Trials Regulatory Lead (Grant-Funded)

Temple University; Philadelphia (Philadelphia County); On-site; USD 50,000 - 55,000; Full time

Benefits offered by this job

Full medical, dental, vision coverage

Paid time off 11 holidays

Tuition remission for employees and/or

A generous retirement plan

Job summary

Temple University, Lewis Katz School of Medicine, seeks a Regulatory Program Coordinator to support regulatory oversight for Phase I–IV trials. On-site position in Philadelphia with responsibilities including IRB submissions, regulatory documentation, and site monitoring.

The role requires a Bachelor’s degree and at least three years of regulatory/compliance experience in research settings. Grant-funded work with clerical and coordination duties across study teams.

Qualifications

• Bachelor’s degree and at least three years of experience in research and/or regulatory compliance in a research or clinical setting.
• Equivalent combination of education and experience may be considered.

Responsibilities

• Assist to maintain oversight of all regulatory compliance monitoring including internal and external progress reports.
• Prepare and process regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events.
• Organize and maintain regulatory affairs documentation/files.
• Support compliance and quality assurance activities.
• Participate in site visits, monitoring, audit and close out visits.
• Train research personnel on consent processes/forms and regulatory documents.

Skills

Federal regulations

MS Word

MS PowerPoint

MS Access

Education

Bachelor’s degree

Tools

MS Word

MS PowerPoint

MS Access

Job description

Temple University, Lewis Katz School of Medicine, seeks a Regulatory Program Coordinator to support regulatory oversight for Phase I–IV trials. On-site position in Philadelphia with responsibilities including IRB submissions, regulatory documentation, and site monitoring.

The role requires a Bachelor’s degree and at least three years of regulatory/compliance experience in research settings. Grant-funded work with clerical and coordination duties across study teams.