Clinical Trials Program Specialist
4 weeks ago
Essential Duties
1. Manages processing, tracking, and filing of study documents and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, and Instructions for Use. 2. Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents. 3. Collates aggregate study data into reports for external audiences including data and safety monitoring groups, regulatory authorities, and project funders. 4. Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 5. Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems, and regulatory document systems. 6. Assists in implementation of improvements and, solutions and assistance as needed under the supervision of senior team members. 7. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 8. Assists in the development and preparation of budgets. 9. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 10. Ensures compliance with University and federal regulations as they apply to the assigned departments. 11. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 12. May perform other duties as assigned.
Required Education and Experience
Bachelor's Degree in related field and two year of related experience or an equivalent combination of education and experience.
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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Position Focus:
An Associate Professor/Principal Investigator in the Reproductive Sciences Division, Department of Obstetrics, Gynecology & Reproductive Sciences, seeks a Clinical Trials Specialist to assist in a new clinical study start up and two ongoing clinical-translational studies in metabolic and gynecology research. The activities of this position include direct patient and participant contact, coordinating a re-contacting campaign, recruiting and consenting participants, and liaising with the Yale Institutional Review Board (IRB) and the Yale Centers for Clinical Investigation (YCCI).
Preferred Education, Experience and Skills:
Experience with communicating through social media. Management skills in implementing large projects. Ability for conversational Spanish, or fluency in Spanish.
Posting Disclaimer
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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