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.
Required Skill/ability 1: Demonstrated experience in clinical or basic research and or scientific grant writing.
Required Skill/ability 2: Ability to interact with scientists at different levels across disciplines.
Required Skill/ability 3: Excellent writing and interpersonal skills.
Required Skill/ability 4: Outgoing personality who is motivated, reliable and flexible, and who can work both independently and within a team.
Preferred Education: Advanced degree or relevant certification (Ph.D., RN, PMP) with 3-5 years of experience in project management, with priority to candidates with clinical research or grant writing experience. Experience with fundraising.
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: Manager 4, Clinical Research
University Job Title: Manager YCII
Preferred Education, Experience and Skills: Advanced degree or relevant certification (Ph.D., RN, PMP) with 3-5 years of experience in project management, with priority to candidates with clinical research or grant writing experience. Experience with fundraising.
Bachelor of Science in Nursing or related field and six years of related experience or an equivalent combination of education and experience.
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.