Actalent Hiring for Research Regulatory Coordinator (REMOTE) at Atlanta, GA Full Time

Description:
The Clinical Research Regulatory Coordinator will support clinical research teams (physicians, nurses, etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies involving human subjects. Will be responsible for ensuring that all research studies are compliant with regulations as well as maintain accurate and up-to-date regulatory files. Will serve as a central resource for staff conducting clinical research. This position reports to the Director, Clinical Research. Essential Functions:

• Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
• Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
• Remains informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
• Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
• Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
• Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.

Additional Skills & Qualifications:
2+ years of experience in regulatory

Experience editing ICF (Informed consent forms)

Experience with local/commercial IRBs (commercial is preferred; commercial = central, that is what Hoag uses)

Experience with initial IRB applications, amendments, continuing reviews

Can be 100% remote with occasional travel as needed to Beverly Hills, CA

must reside in one of these approved states: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia

About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.