Coordinates the regulatory affairs activities of the Clinical Trials Office. These activities include, but may not be limited to preparation of documents for submission to the Institutional Review Board (IRB) and ancillary review committees for initial approval, changes in research and continuing review, review unanticipated problems to determine if prompt reporting is required, compile promptly reportable submissions for review committees, maintain the site regulatory files, prepare for and participate in site monitoring visits, internal and external audits and inspections and review and appropriately handle new information related to protocols funded by Yale Cancer Center, Cooperative Groups or pharmaceutical sponsors.
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. 14. May perform other duties as assigned.
Required Education and Experience
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.
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 2:
Proven ability to work well in a clinical or research environment including but not limited to animal research, human research, quality assurance or regulatory affairs. Working knowledge of medical terminology.
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.
Required Skill/Ability 4:
Ability to draft, proofread, and amend complex documents. Proven ability to be meticulous with details.
Required Skill/Ability 5:
Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment.
Preferred Education, Experience and Skills:
Advanced computer proficiency with Microsoft Office programs and online databases. Prior experience with research regulatory requirements. Knowledge of medical and oncology terminology.
Ability to sit for prolonged periods of time.
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at [email protected], or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: [email protected]
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