Job Description:
We are seeking a detail-oriented and highly organized Clinical Research Regulatory Coordinator to join our research team. This role is responsible for overseeing the regulatory aspects of clinical trials, ensuring compliance with all regulatory requirements, and maintaining essential study documentation. The ideal candidate will play a critical role in supporting the research team, ensuring the ethical conduct of studies, and safeguarding patient rights and safety.
Key Responsibilities:
- Regulatory Document Preparation: Prepare, submit, and maintain regulatory documents, including IRB submissions, amendments, safety reports, and renewals for all clinical trials.
- Compliance Monitoring: Ensure that all studies adhere to local, state, and federal regulations, as well as institutional policies and Good Clinical Practice (GCP) guidelines.
- Protocol Review and Approval: Manage the submission and tracking of study protocols, amendments, and consents through regulatory and ethics committees.
- Study Start-Up and Close-Out: Coordinate regulatory requirements during study start-up, maintenance, and close-out phases, ensuring all documentation is current and complete.
- Informed Consent Documentation: Review and verify informed consent forms to ensure compliance with regulatory and protocol-specific requirements.
- Audit and Inspection Preparation: Support preparation for audits and inspections by regulatory authorities and sponsors, ensuring all regulatory documents and records are inspection-ready.
- Education and Training: Train study team members on regulatory requirements and compliance policies; serve as a resource for regulatory questions and issues.
- Record Maintenance: Maintain up-to-date regulatory binders and study files, ensuring documentation accuracy, accessibility, and compliance with retention policies.
- Reporting and Communication: Facilitate communication between the study team, investigators, sponsors, and regulatory bodies; report protocol deviations, adverse events, and safety information as required.
Qualifications:
- Education: Bachelor’s degree in a health science field; certification in clinical research (e.g., SOCRA, ACRP) preferred.
- Experience: Minimum of 2-3 years of experience in clinical research with a focus on regulatory compliance.
- Knowledge: Strong knowledge of clinical research regulatory requirements, including FDA regulations, GCP guidelines, and IRB processes.
- Skills: Exceptional organizational skills, attention to detail, and proficiency in regulatory documentation software and clinical trial management systems.
- Communication: Strong written and verbal communication skills, with the ability to manage multiple tasks and meet regulatory deadlines.
What We Offer:
- Competitive Salary commensurate with experience
- Comprehensive Benefits Package including health, dental, and retirement options
- Professional Development Opportunities for continuing education and certification
- Supportive Team Environment dedicated to ethical and impactful research
If you are passionate about regulatory compliance and clinical research, we invite you to apply for this essential role.
