Full job description Job Description:
The Regulatory Coordinator coordinates regulatory requirements integral to the conduct of clinical research. Ensures regulatory and organizational compliance in the compilation of complete, accurate, organized critical documents for physicians, study sponsors, Contract Research Organizations, and Institutional Review Boards. Routinely works with sensitive or confidential information, documents and issues.
Primary Duties:
Facilitates the protocol approval process and maintains regulatory compliance for all Research projects submitted to the Central Research Office (CRO). Prepares and maintains regulatory documents and Institutional Review Board (IRB) submissions for all Central Research Office's managed protocols. Plans, prepares and manages timelines for assigned regulatory documentation including initial submissions, meeting requests, protocol assistance and annual reports. Initiates, collects and coordinates information to prepare regulatory documentation packages for review and Monitors and tracks status of pending protocols for Research Oversight Committee (ROC) and IRB review and approval Prepares and submits initial protocol, informed consent form, FDA Form 1572 and the investigator brochure and any revisions throughout the course of the study Prepares and submits all study related recruitment materials to the sponsor & IRB for review and approval Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor Ensures safety letters are reviewed by the Principal Investigator and submitted to the IRB Prepares and submits interim status reports and final summaries to the sponsor and IRB describing study activity Oversees preparation of all closed study files for archiving in long term storage Serves as contact for research projects and maintains records and corresponds with all parties involved Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatory compliance Additional Skills & Required Qualifications:
Bachelor's Degree required, preferably in a healthcare / health sciences related field with 2 years experience in clinical research or IRB functions OR Master's Degree with 1 year experience in clinical research or IRB functions. Knowledge about clinical research administration, regulatory requirements. Knowledge of key research regulations (e.g., FDA / OHRP / ORI / DHHS / NIH) General understanding of human subject protection and Institutional Review Board regulation and operation Computer proficient in Microsoft WORD, EXCEL, ACCESS and PowerPoint applications. Strong attention to detail and ability to adhere to policies and procedures Effective organizational skills, effective follow-through and commitment to excellence Strong interpersonal skills; ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment Ability to work collaboratively in a team environment Must be flexible and adaptable as conditions and environment are unpredictable and change frequently Able to track multiple projects simultaneously Effective professional communication skills; ability to communicate with others in a clear, understandable and professional manner About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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