Senior Clinical Research Regulatory Lead

University of Pennsylvania; Philadelphia (Philadelphia County); Sur place; USD 76 000 - 86 000; Plein temps

Avantages offerts par ce poste

Health benefits

Tuition benefits

Retirement plans

Flexible work hours

Wellness programs

Résumé du poste

The University of Pennsylvania’s Perelman School of Medicine seeks a Clinical Research Regulatory Specialist C to lead regulatory operations for clinical research, including submissions to IRBs, committees, sponsors, CROs, and agencies. You will oversee regulatory documentation and quality, guiding study initiation, monitoring, audits and close-out visits.

Ideal candidates have a Bachelor's degree with 5–7 years of experience and at least 2 years in regulatory roles; RAC/CCRP/CIP preferred.

Qualifications

• Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.
• At least 2 years of regulatory experience preferred. Associated credentialing (RAC, CCRP, CIP, etc.) preferred (or to be completed within 1 year of employment).

Responsabilités

• Lead the coordination of unit clinical research, including but not limited to Phase I-IV clinical trials.
• Independently prepare and process all regulatory documentation/applications through the IRB and requisite ancillary review committees.
• Independently prepare and process all required regulatory documentation for pharmaceutical companies, CROs, and required governmental agencies, as well as organize and maintain all regulatory affairs documentation/investigator site files (ISF).
• Resolve regulatory and data queries as required, and lead initiation, monitoring, audit and close-out visits related to the conduct of the research at the site.
• Lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings.
• Lead the development of unit guidance/process documents including work tools, and development/maintenance of study specific case report forms, and provide direct regulatory/compliance guidance.
• Serve as a mentor and/or trainer to more junior members of the regulatory research team/study team.
• Assist with the purchasing and requisition of supplies needed to conduct and operate clinical trials.
• Perform additional regulatory duties as assigned.

Connaissances

IRB submissions

Regulatory documentation

Regulatory guidance

Mentoring junior staff

Formation

Bachelor's degree

Description du poste

The University of Pennsylvania’s Perelman School of Medicine seeks a Clinical Research Regulatory Specialist C to lead regulatory operations for clinical research, including submissions to IRBs, committees, sponsors, CROs, and agencies. You will oversee regulatory documentation and quality, guiding study initiation, monitoring, audits and close-out visits.

Ideal candidates have a Bachelor's degree with 5–7 years of experience and at least 2 years in regulatory roles; RAC/CCRP/CIP preferred.