Senior Regulatory Affairs Research Coordinator

2 weeks ago

Providence, Rhode Island, United States Lifespan Full time

Position Overview:
The Senior Regulatory Affairs Research Coordinator plays a crucial role in overseeing clinical trials by managing the regulatory aspects of the trial submission process, ensuring compliance from initiation to conclusion. This position is pivotal in maintaining the regulatory integrity of assigned clinical studies and involves a variety of tasks to meet research compliance standards.

Key Responsibilities:
The Senior Regulatory Affairs Research Coordinator is accountable for a range of duties, including but not limited to:
• Collaborating with the Principal Investigator to develop research protocols and providing strategic recommendations.
• Coordinating the submission of regulatory documents to the Institutional Review Board (IRB), including communication with ancillary committees, study teams, and sponsors.
• Preparing and maintaining study-specific regulatory binders and documentation.
• Serving as the regulatory subject matter expert throughout all phases of clinical studies, ensuring adherence to regulatory processes.
• Initiating and leading special projects focused on process enhancement and regulatory training.
• Ensuring compliance with all regulatory requirements as mandated by sponsoring agencies.
• Liaising with sponsors, investigators, and team members to provide updates and trial information in a timely manner.

Additional Duties:
The Senior Regulatory Affairs Research Coordinator will also:
• Facilitate the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications.
• Manage the preparation of annual reports to regulatory bodies as required.
• Oversee the maintenance of clinical trial information on relevant platforms.
• Ensure the collection and upkeep of credentialing information for study personnel, including conflict of interest forms and training documentation.
• Coordinate audits and site visits, ensuring compliance with regulatory documentation.
• Prepare for institutional, federal, and sponsor audits, assisting in drafting responses.
• Mentor new regulatory affairs personnel and enhance the department's mentorship initiatives.
• Collaborate with department leadership to explore opportunities for regulatory innovation and implement novel solutions to challenges.

Qualifications:

  • Bachelor's degree in a health-related or scientific discipline is required; a Master's degree is preferred.
  • Certification from the Society of Clinical Research Associates (SoCRA) or eligibility within 18 months of hire.
  • Comprehensive understanding of federal, state, and local regulations governing clinical research.
  • Ability to work independently and exercise sound judgment regarding regulatory matters.
  • Demonstrated leadership and organizational capabilities.

Skills:
• Detail-oriented with exceptional organizational skills.
• Strong self-starter with effective interpersonal abilities.
• Excellent problem-solving skills and a team-oriented mindset.
• Proficient in Microsoft Office and various database applications.
• In-depth knowledge of FDA guidelines and the ability to foster effective communication among clinical research teams.

Experience:
• 3-5 years of direct experience in clinical trial administration or relevant regulatory roles.
• Previous experience with compliance in federal, state, and local regulations.

Work Environment:
This role is primarily sedentary, requiring the ability to transport paperwork and perform filing tasks. Standing may be necessary for copying documents.

Supervisory Responsibilities:
This position may involve overseeing one to three regulatory staff members.

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran status, or marital status.

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