Senior Clinical Trials Regulatory Lead

Temple University; Philadelphia (Philadelphia County); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

11 holidays

Tuition remission

Retirement plan

Job summary

Temple University is seeking a Sr. Regulatory Program Coordinator in the Lewis Katz School of Medicine.

You will coordinate IRB submissions and regulatory actions for phase I–IV clinical trials, interfacing with sponsors, PIs, and clinical staff. The role requires a Bachelor’s degree with at least five years in research or regulatory compliance, strong communication, documentation, and organizational skills, and willingness to travel for study training and meetings.

Qualifications

• Bachelor’s degree and at least five years of experience in research and/or regulatory compliance.
• Equivalent combo of education and experience may be considered.

Responsibilities

• Coordinate IRB submissions, protocol changes, and continuing review.
• Review documents for validity, readability and consistency.
• Negotiate consent forms for standard language and clarity.
• Maintain timelines and communicate progress to investigators.
• Track metrics to support program growth and efficiency.
• Assist sponsor monitoring visits and audits as needed.

Skills

Detail oriented

Interpersonal skills

Analytical skills

Organizational skills

Prioritization

Effective communication

Teamwork

Independent work

Travel readiness

MS Office proficiency

Written communication

Education

Bachelor's degree

Tools

MS Office

Job description

Temple University is seeking a Sr. Regulatory Program Coordinator in the Lewis Katz School of Medicine.

You will coordinate IRB submissions and regulatory actions for phase I–IV clinical trials, interfacing with sponsors, PIs, and clinical staff. The role requires a Bachelor’s degree with at least five years in research or regulatory compliance, strong communication, documentation, and organizational skills, and willingness to travel for study training and meetings.