Under the direction of the Assistant Director of Clinical Research Operations and the supervision of the Regulatory Manager, the Regulatory Coordinator will assist in the start-up and management of clinical studies in the CPDM Office. The Regulatory Coordinator will assist with IRB/FDA submissions and preparing/maintaining protocol-specific regulatory documents for the initiation, implementation, ongoing monitoring, and formal closure of assigned clinical trials. Will serve as a primary regulatory contact for studies (for both internal and external stakeholders); ensuring that regulatory compliance is met and that regulatory files are audit ready. This position is primarily based out of 400 Kelby Street, Fort Lee, NJ.

 

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed

during the interview process.

Responsibilities include, but are not limited to:

• Coordinates all aspects of protocol submission for research projects.
  • Prepares and submits all necessary documents to the Institutional Review Board (IRB) and Protocol Review Monitoring Committee (PRMC), and ancillary committees

• Ensures regulatory approvals for all required components of human subject research/clinical trials are obtained and maintained accordingly.
  • Annual IRB renewal submissions and ancillary review committee annual reports
  • FDA annual reports (as needed)
  • Timely submission of all required documents
  • Official reporting of Unanticipated Problems to the IRB of record (as applicable)

• Coordinates assigned study monitoring and auditing visits with the study coordinator, investigator, industry sponsors, and internal/external auditors.
  • Assists in preparations for routine monitoring and audit visits for assigned clinical trials

• Serves as an integral part of disease-specific research teams.
  • Attend and present at recurring research team meetings
  • Maintains and disseminates accurate listings of active and potential studies to participating investigators
  • Serves as the resource for current regulatory information/statuses for assigned protocols

• Performs other miscellaneous tasks as needed.
• Coordinator performs other related duties and participates in special projects as assigned.

• Excellent interpersonal and organizational skills.
• Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
• Preferred certification as a Clinical Research Professional through a national accrediting body such as
  ACRP, RAPS, PRIM&R CIP, and/or SOCRA.