1. Manages and conducts recruitment and assessment study components of all clinical research studies. In conjunction with the PI, develops timelines and protocols. 2. Acts as project manager in studies involving multiple sites. Oversees quality and recruitment, and responsible for organizational planning for all sites. 3. Manages a team of research staff. 4. Develops protocols for sample collection and long term storage in biorepository in studies involving tissue collection. 5. Assists the PIs with budget preparation for grants, tracking of funds, and managing of subcontracts with participating sites. 6. Develops, implements procedures and data quality assurance standards and creates and maintains Manual of Operations for recruitment and assessment, and sample collection components of studies. Prepares and adjusts recruitment and assessment study plans by designing strategies and analyzing relevant data. 7. Prepares IRB submissions, annual re-approvals, and requests for amendments for the Yale IRB as well as applications to other IRBs and governing institutions involved in the studies. 8. Participates in the design of conduct of study reports. Evaluates recruitment and assessment study progress on an ongoing basis. 9. Determines subject's eligibility and acceptability to clinical studies based on the study inclusion and exclusion criteria from screening assessments. 10. Obtains and interprets medical outcome data and clinical test results from other sources: hospitals, physicians' office, and death certificates. 11. Establishes and implements an adverse monitoring protocol if necessary. 12. Prepares educational seminars and material to enhance staff knowledge and awareness of the purpose and value of the study. 13. Organizes retention events, including dinner and luncheon meetings. 14. May perform other duties as assigned.
Preferred Education: Master's degree preferred and at least five years experience in clinical research in an academic setting. Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring. Comprehensive knowledge of federal regulations for protection of human subjects and clinical trial design, implementation, analysis. Advance knowledge of auditing and monitoring techniques.
Preferred Education, Experience and Skills: Master's degree preferred and at least five years experience in clinical research in an academic setting. Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring. Comprehensive knowledge of federal regulations for protection of human subjects and clinical trial design, implementation, analysis. Advance knowledge of auditing and monitoring techniques.
Required Skill/ability 5: Demonstrated ability to assess safety concerns and provide risk analysis related to clinical research protocols. Demonstrated ability to triage and prioritize critical issues related to subject safety and/or compliance as identified in study summary reports, audits, patient complaints or inquiries from staff or faculty expressing concerns.
Posting Position Title: Manager 4, Clinical Research
Required Skill/ability 3: Advanced communication skills. Strong written, oral and presentation development and delivery. Ability to problem solve with input from stakeholders in non-homogeneous groups of university and external participants. Experience preparing budgets, forecasts, financial plans and integrating complex pieces of financial information to identify themes, trends, issues.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Assistant Director of Clinical Trial Project Mgmt
Required Skill/ability 1: Strong ability to inspire change and transform organizations. Strong interpersonal skills and ability to work well and communicate effectively with external organization and funders, faculty, and staff, one-on-one and in group settings. Strong organizational and analytical skills. Strategic planning and organizational assessment/evaluation skills.
Required Skill/ability 4: Extensive knowledge in federal and state regulations protecting human subjects in research, grants management and research regulation; eight or more years in a leadership position. Comprehensive technical knowledge of FDA and EMA data standards, regulations, management, coding requirements. Clinical trial prjct management. FDA electronic clinical trials data submission.
Required Skill/ability 2: Comprehensive and advanced communication skills, including strong written, oral and presentation development and delivery. Ability to problem solve with input from a variety of stakeholders and often in large, non-homogeneous groups of university and external project participants.
Bachelor of Science in Nursing or related field and six years of related experience or an equivalent combination of education and experience.
Internal Number: 62123BR
About Yale University
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.