Clinical Trials Regulatory Specialist III- Winship Cancer Institute

Emory•Atlanta, GA

1d•Onsite

About The Position

Winship Cancer Institute of Emory University is seeking qualified candidates for the Clinical Trials Regulatory Specialist position. This is an advanced level role supporting regulatory affairs in clinical trials research. The specialist will handle all trial complexities, manage the study activation process, and serve as an internal project manager for assigned oncology disease groups. This role involves providing timely updates on submission status and regulatory guidance, acting as a liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments. Incumbents may also supervise and train junior specialists, lead task forces, and contribute to project/process improvements.

Requirements

Bachelor's degree and five years of experience in a research environment, or an equivalent combination of experience, education and training.
Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
Must obtain all required training courses within one month of hiring date.
Must possess an applicable research certification within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).

Responsibilities

Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Responsible for managing a trial load of 35+ trials per year, including NCTN, industry, and investigator-initiated trials.
Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
Reviews processes involving regulatory documentation, including but not limited to NCTN/NCI informed consent review, to assure appropriate timelines are followed.
Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents (e.g. DSMC review) are in place.
Disseminates information and coordinates or conducts training.
Researches and analyzes problems and takes a leadership role in resolving.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
Actively participates in designated committees within the unit and Emory University.
Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
Perform internal audit and quality assurance checks on regulatory documents.
Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
Completes protocol renewal applications and amendment applications.
Attends research team meetings to report on regulatory updates and issues.
Responsible for administrative duties corresponding to budgets and contracts.
Single patient/compassionate use submission and maintenance across disease types.
Performs related responsibilities as required.