What are the responsibilities and job description for the Clinical Research Regulatory Coordinator position at Children's Hospital of Philadelphia?
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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.
A Brief Overview
This role will support sponsor oversight of investigator-initiated CAR T cells studies in the Cell Therapy and Transplant Section. The role will support the sponsor and principal investigators by drafting protocol, consent, and IND application documents, liaise with regulatory authorities (including FDA, IRB, and DSMB), create reports for regulatory stakeholders (CRs, IND annual reports, periodic study reports), create and maintain regulatory binders, assist in study start up, submit regulatory correspondence, facilitate internal and external monitoring and auditing of site investigator/regulatory files, and perform other duties as assigned.
This role assumes a central, key role for all studies conducted under the auspices of assigned studies. This position will create and maintain site investigator/regulatory binders, submit correspondence to the relevant group including Institutional Review Boards and/or Pediatric Protocol Review Committee, track study approval and expiration dates, facilitate internal and external monitoring and auditing of site investigator/regulatory files and perform other duties as assigned.
What you will do
- Author/edit protocols, informed consent forms, IND applications, and other study documents for CAR T cell clinical trials.
- Serve as the liaison on behalf of the sponsor and study PI to regulatory bodies like the Food and Drug Administration, CHOP Institutional Review Board, Data Safety Monitoring Board, and other stakeholders.
- Develop study reports for active CART T cells studies for regulatory bodies and stakeholders
- Support protocol start up, which includes submissions to relevant groups, development of databases, case report forms, etc.
- Submit new and amended studies including new protocols, amendments, continuing reviews, serious adverse events, safety reports, unanticipated problems and deviations; serve as the liaison for the Study PI regarding regulatory issues
- Facilitate internal and external monitoring and auditing of regulatory files by stakeholder entities
- Work collaboratively and effectively with study team, collaborators, and other institutions
Education Qualifications
- Bachelor's Degree Required
- Master's Degree Preferred
Experience Qualifications
- At least two (2) years of clinical research, regulatory or related experience Required
- At least three (3) years of clinical research, regulatory or related experience Preferred
Skills and Abilities
- Intermediate knowledge of clinical research and regulatory protocols
- Intermediate proficiency with office software (Microsoft Office) including word processing and spreadsheet software (Word, Excel)
- Excellent written and verbal communication skills
- Strong interpersonal skills
- Strong organizational skills
- Strong time management skills
- Ability to be flexible and adaptable to change
Licenses and Certifications
- Certified Clinical Research Associate (CCRA) - Association of Clinical Research Professionals (ACRP) - upon hire - Preferred and
- Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA) - upon hire - Preferred
To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.
Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.
EEO / VEVRAA Federal Contractor | Tobacco Statement
Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
