Clinical Trials Regulatory Specialist III- Winship Cancer Institute

Emory University•Brookhaven, GA

20h•Onsite

About The Position

Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and inspiring hope. Winship researches, develops, teaches, and provides novel ways to prevent, detect, diagnose, treat, and survive cancer, offering care that includes leading cancer specialists, innovative therapies, clinical trials, comprehensive patient and family support, and a personalized care experience. Winship is seeking qualified candidates for the Clinical Trials Regulatory Specialist III position, an advanced level role supporting regulatory affairs in clinical trials research. This position involves managing the study activation process for all trial complexities, from basic to multiphase, and serving as an internal project manager for specific oncology disease groups.

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

Support regulatory affairs in clinical trials research.
Support all trial complexities (basic to multiphase) and manage the study activation process.
Serve as the internal project manager for assigned specific oncology disease group(s), providing timely updates on the status of submissions and regulatory guidance on study development.
Act as a liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.
Supervise/train Specialist Is and IIs, lead project specific task forces, and/or serve as project/process improvement leads (may apply to incumbents in this job class).
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 35+ trial load per year of NCTN, industry and investigator-initiated trials.
Establish and maintain processes and monitor practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
Review 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 communicate to allow for enrollment to start and maintain once regulatory documents (e.g. DSMC review) are in place.
Disseminate information and coordinate or conduct training.
Research and analyze problems and take 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.
Participate 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 participate 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.
Complete submission applications, and other required documentation, prepare protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Serve as lead contact for each assigned trial, maintain records and correspond with all parties involved (institutional, federal, pharmaceutical).
Complete protocol renewal applications and amendment applications.
Attend research team meetings to report on regulatory updates and issues.
Responsible for administrative duties corresponding to budgets and contracts.
Perform single patient/compassionate use submission and maintenance across disease types.
Perform related responsibilities as required.