Our Ability Jobs

Employer Name: Yale University

1. Ensures policies and procedures are being followed and met on a day-to-day basis in accordance with established department guidelines. 2. Advises faculty and administrators seeking external funding for research and other sponsored programs on format, regulatory compliance, submission policies, pre and post award requirements and University, School, Federal and State regulations governing sponsored research. 3. Provides assistance to investigators and department staff in the development of proposals, budgeting, interpretation of sponsor terms and policies and University policies and procedures. 4. Reviews, authorizes, and transmits grant and contract proposals to sponsors; consults with appropriate managerial staff on any exceptions to University policy. 5. Review terms and conditions on award documents; negotiate terms as necessary for interdisciplinary, complex and non-standard proposals and agreements, including subcontracts, clinical trials and state agreements to ensure conformity with University policies. 6. Ensure key personnel are compliant with Conflict of Interest, Human Subject, Animal, Safety, HIPPA and other training mandates. 7. Keep abreast of laws, regulations, external and internal policies and procedures governing the administration of grants and contracts and serve as a resource to faculty and staff. 8. Obtain, evaluate and communicate information on sponsor electronic research processes and procedures. 9. Coordinate filing of sponsor required reports (financial, technical and patent) in conjunction with other University departments. 10. May perform other duties as assigned. Required Skill/ability 1: Knowledge of the drug development process, prevention, detection, treatment, and clinical trial designs. Knowledge of federal regulations and guidance documents governing the conduct of clinical trials. Required Skill/ability 2: Proven ability to manage and evaluate orientation, education, and professional developmental needs for research staff using the CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts. Required Skill/ability 3: Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Proven experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance. Required Skill/ability 4: Demonstrated clinical research skills and specialized knowledge of the unique needs of patients undergoing treatment in high acuity trials. Required Skill/ability 5: Ability to assess, prioritize and delegate critical research tasks to support team. Preferred Education: Bachelor's Degree and 5 years of clinical research experience with a minimum of 3 years in a management role supervising clinical research in a hospital/academic or industry setting. Degree in a medically related field (nursing, psychology, behavioral , biomedical sciences etc.) preferred. Advanced degree or certification is a plus. Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Manager 2, Research Res Support University Job Title: Clinical Research Project Manager-PRISMS Preferred Education, Experience and Skills: Bachelor's Degree and 5 years of clinical research experience with a minimum of 3 years in a management role supervising clinical research in a hospital/academic or industry setting. Degree in a medically related field (nursing, psychology, behavioral , biomedical sciences etc.) preferred. Advanced degree or certification is a plus. Minimum requirement of Bachelor's Degree in related field and three years of related experience or an equivalent combination of education and experience.