Provide Yale Cancer Center Clinical Trials Office team with regulatory affairs support in the coordination and submission of regulatory activities. These activities include, but may not be limited to preparation of documents for submission to the Protocol Review Committee, Institutional Review Board, and maintenance, submissions of regulatory files, interactions with study team members, industry sponsors, and others. |
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1. Provides specialized information on administrative, academic, financial aid, and procedural matters to students, prospective students, faculty, and staff.
2. Assists staff, faculty and students with the completion of forms. Identifies and resolves errors through contact with students and University departments. Maintains logs and records of activities.
3. Compiles statistical data and information. Establishes and maintains filing systems.
4. Uses computer terminal to input and retrieve data. Merges and manipulates filing systems. Uses computer terminal to input and retrieve data. Merges and manipulates data to generate complex reports. Monitors and reconciles financial data.
5. Keyboards letters, memoranda and other materials. Composes general written material.
6. Schedules and coordinates conferences, meetings, appointments, and classrooms.
7. May oversee and instruct support staff.
8. Performs clerical functions incidental to office activities.
Required Education and Experience
Four years of related work experience, two of them in the same job family at the next lower level, and high school level education; or two years of related work experience and an Associate's degree; or an equivalent combination of experience and education.
Required Skill/Ability 1:
Ability to prepare initial submissions and amendments for submission to the PRC/HIC/IRB, update the Yale Cancer Center protocol.
Required Skill/Ability 2:
Ability to obtain and ensure completion of applicable study start-up documents (i.e., delegation of authority, Form FDA 1572s, protocol/investigator’s brochure (IB) signature pages, CVs, Financial Disclosure Statements, Laboratory Certificates, applicable Lab Normals/Reference Ranges, etc.).
Required Skill/Ability 3:
Ability to communicate with the appropriate Yale Cancer Center staff regarding protocol submissions and approvals.
Required Skill/Ability 4:
Ability to prepare, process, and submit protocol status changes to the HIC/IRB, update the protocol database shared drive with submission and approval information, update the regulatory binders for Yale Cancer Center studies, communicate with study team members with regulatory updates.
Preferred Education, Experience and Skills:
Experience coordinating and planning or working in a high volume multi-task setting; experience working in a research or clinical trials setting; experience with regulatory filing and upkeep; certification as a Clinical Research Associate; knowledge of federal regulations concerning clinical research reporting requirements; knowledge of HIPPA and IRB. Expert with use of computer applications.
Ability to lift 30 lbs. Ability to sit for long periods of time. Ability to travel on foot to locations within the medical school campus within roughly a mile radius of the office.
Weekend Hours Required?
Evening Hours Required?
Background Check Requirements
All external candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle and credit checks based on the position description and job requirements. All offers are contingent on successful completion of a 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.
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