Clinical Research Regulatory Specialist C

Opportunity for Health; Philadelphia (Philadelphia County); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health, Life, and Flexible Spending

Tuition benefits

Long-Term Care Insurance

Wellness and Work-life Resources

Résumé du poste

The University of Pennsylvania's Perelman School of Medicine seeks a regulatory research professional to coordinate unit clinical research, manage regulatory submissions through the IRB and review committees, and maintain regulatory documentation andISF files for sponsors and agencies.

You will lead initiation, monitoring, audits, and close-out visits; supervise junior staff, develop study tools, and assist with procurement of trial supplies.

Qualifications

• Experience coordinating regulatory aspects of clinical trials (Phase I–IV).
• Ability to prepare regulatory submissions and maintain ISF/documents.
• Strong knowledge of IRB/ethics review processes and sponsor interactions.

Responsabilités

• Coordinate unit clinical research including Phase I–IV trials.
• Prepare and process regulatory documentation through the IRB and review committees.
• Maintain regulatory documentation/ISF files for sponsors and governmental agencies.
• Lead initiation, monitoring, audit and close-out visits.

Connaissances

Regulatory documentation

IRB submissions

Regulatory compliance

Clinical research coordination

Team leadership

Mentoring/Training

Vendor coordination

Description du poste

* 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. Regulatory applications may include new study submissions, continuing reviews, amendments, adverse events, and reportable events.* Independently prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), and required governmental agencies, as well as, organize and maintain all regulatory affairs documentation/investigator site files (ISF) as required.* Resolve regulatory and data queries as required, and lead the conduct of 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, as well as, to 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.**Health, Life, and Flexible Spending Accounts**: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.**Tuition**: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.**Long-Term Care Insurance:** In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.**Wellness and Work-life Resources**: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.The Perelman School of Medicine's mission is to advance knowledge and improve health through research, patient care, and the education. Our inclusive culture embraces diversity, fosters innovation, stimulates critical thinking, supports lifelong learning, and sustains our legacy of excellence.The University of Pennsylvania seeks talented faculty and staff for our vibrant community. Our institution is committed to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.