Regulatory Program Coordinator

About the role

Temple University's Lewis Katz School of Medicine's Pulm/Critical Care/SleepMed Department is seeking a Regulatory Program Coordinator to join the team. The role supports the coordination of active Phase I‑IV clinical trials, interacts with study sponsors, principal investigators, and research staff, and works under the supervision of the Regulatory Manager within the Thoracic Medicine & Surgery department. This is an on‑site, grant‑funded position that requires a cash handling background check.

Responsibilities

• Maintain oversight of regulatory compliance monitoring, including internal and external progress reports
• Prepare and process all regulatory documentation through the IRB (new submissions, continuing reviews, amendments, adverse events, reportable events)
• Organize and maintain regulatory affairs documentation/files
• Support compliance and quality assurance activities
• Participate in site visits, monitoring, audits, and close‑out visits
• Attend study team meetings, required group meetings, and ongoing protocol training/compliance meetings
• Assist in developing investigator‑initiated protocols, IND applications, and annual reports
• Provide regulatory compliance guidance for investigator‑initiated multi‑center trials
• Train research personnel on consent processes/forms and regulatory processes/documents
• Perform other duties as assigned

Requirements

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

Skills

• Knowledge of complex federal regulations, ethical issues, institutional policies, and federal agency requirements governing human subjects research
• Understanding of quality assurance or auditing functions
• Proficiency with MS Word, MS PowerPoint, MS Access or similar software
• Excellent interpersonal and customer service skills; ability to collaborate with a diverse population
• Excellent verbal and written communication skills, including training skills
• Strong organizational and time management skills; ability to work under tight deadlines
• Detail‑oriented
• Ability to work independently and as part of a team
• Maintain working knowledge of current regulations, guidelines, and trends influencing human subjects research
• Ability to travel to off‑site locations that may not be accessible via public transportation
• Preferred: experience with biomedical human research

Benefits

• Full medical, dental, and vision coverage
• Paid time off
• 11 paid holidays
• Tuition remission – eligible employees and dependents can obtain a degree tuition‑free
• Generous retirement plan

Pay

Salary Grade: T25; Salary Range: $60,000.00 – $65,000.00

Schedule

On‑site position