Applicants must be able to work on site around Atlanta, GA. This is a direct hire opportunity. Position Summary: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. Responsibilities:
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 & 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
Strong interpersonal skills
Ability to work collaboratively in a team environment
Able to track multiple projects simultaneously
Must haves:
Oncology experience required
Strong understanding of GCP guidelines and FDA requirements
Experience handling high volume studies (50+) and knowledgeable end to end (start up, maintenance, and close out)
Experience handling IRB submissions to a centralized system
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.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.