1. Processes new protocols by preparing submission documents to the institutional review board (IRB). 2. Acts as a liaison between the Yale Cancer Center (YCC) and IRB to streamline the approval process by staying current with IRB requirements and addressing requests for revisions to protocol documents. 3. Processes all protocol amendments; prepare and submit protocol amendments to the Protocol Review Committee, ancillary review committees and to the IRB, update the clinical trial tracking system with submission and approval information, update the regulatory binders, and communicate with the appropriate YCC research, laboratory and pharmacy staff regarding amendment submissions and approvals, and track completion of amendment training of all study staff. 4. Processes annual renewal of IRB approval and updates as follows: prepare and submit request for annual renewal and provide updates to the IRB, update the clinical trial tracking system with submission and approval information, update the regulatory binders, and communicate with the appropriate Yale Cancer Center research, laboratory and pharmacy staff regarding annual review submissions and approvals. 5. Processes study status changes, such as study closure notices as follows: prepare and submit protocol status changes to the IRB, update the clinical trial tracking system with study status changes, submission and approval information, update the regulatory binder for YCC studies, communicate with the appropriate research, laboratory and pharmacy staff regarding study status changes. 6. Maintains the YCC clinical research regulatory files (IRB approvals, amendments submissions and approvals, serious adverse event reports, safety reports, annual renewals, etc.). Provides regulatory files to study monitors and auditors and ensures compliance with study specific requirements, YCC and University policies and procedures and appropriate regulations. 7. Acts as a liaison for communication regarding regulatory matters between YCC and the study sponsor including meeting with study monitors and auditors to review regulatory files and responds to issues and queries. 8. Receives and reviews safety reports. Provides principal investigator or designee with reports as required and may assist in reporting external adverse events to the Yale IRB. Maintains log of safety reports and obtains principal investigator oversight as required. 9. Runs special database reports for grants and other reports as requested. 10. Assists the Lead Clinical Research Coordinator with the development and implementation of related policies and procedures to ensure regulatory compliance and efficiency of the regulatory affairs operation. Ensure compliance with all federal and state requirements for the conduct of clinical research. 11. Registers or ensures registration of clinical trials on NIH and NCI designated websites, updates and amends trial information and assists the Principal Investigator in reporting study results. 12. Complies with all YCC policies, procedures, objectives, quality assurance, safety, environmental, and infection control. 13. Advises, screens, and refers callers and visitors.
Preferred Education: Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred. Fundamental knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Education, Experience and Skills: Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred. Fundamental knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Required Skill/ability 5: Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment.
Posting Position Title: Research Assistant 2 HSS, Regulatory Affairs
Required Skill/ability 3: Ability to communicate with the appropriate Yale Cancer Center staff regarding protocol submissions and approvals. Impeccable interpersonal skills and the ability to work as part of a team and independently. Proven ability to communicate effectively, both verbal and written.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Regulatory Coordinator
Required Skill/ability 1: Ability to read and comprehend complex clinical trial protocols and other related documents. Ability to extract key elements for the development of committee applications and consent forms.
Required Skill/ability 4: Proven ability to draft, proofread, and amend complex documents. Proven ability to be meticulous with details.
Required Skill/ability 2: Proven ability to work well in a clinical or research environment, specifically in the areas of quality assurance and/or regulatory affairs. Working knowledge of medical terminology.
Two years of related work experience in the same job family and a Bachelor degree in a related field; or an equivalent combination of education and experience.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.