Job Description
1. Supervises research within the scope of established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. 2. Responsible for reviewing, planning, and implementing study protocols and assessing the impact of program changes on research quality. Identifies and makes initial contact with potential funding sources to secure funds. 3. Oversees the planning of large multi-site or global studies. Establish goals and objectives, training requirements, productivity goals and financial parameters. Develops forms and questionnaires and manages the application of research techniques. 4. Works closely with research faculty and collaborators to identify quality and operational strategies and aspects of study that need to overcome. 5. Fosters and maintains cooperative relationships with principal investigators, collaborators, study coordinators, government officials, international partnerships, and study sponsors to ensure for the safe and timely progression of studies and adherence to all study/agency/government regulations. 6. Develops original HIC/IRB submissions for multi site research. Collaborate with various PI on major revisions and ensure changes are incorporated at each participating site. 7. Uses advanced statistical knowledge to provide support in managing and analyzing data. 8. Develops operational procedures for the collection, editing, verification and management of statistical data. Develops and implements relevant statistical programs to incorporate data from multiple projects. Designs comprehensive and rational databases with advance knowledge of the scientific applications impacting on the data analyses and reporting. 9. Develops protocols for collection of data. Designs data gathering instruments and related procedures. Tests, refines and finalizes instruments for use in research study. 10. Presents talks, seminars or other oral presentations on the methodology and analyses used in scientific studies. 11. Composes major abstracts/publications/manuscript. 12. May perform other duties as assigned.
Required Skill/ability 1: Demonstrated ability in managing large research projects, preferably a mix of industry and federal studies.
Required Skill/ability 2: Proven ability in managing all aspects of Yale and external IRB original submissions, modifications and renewals for multiple institutions, Certificates of Confidentiality, Data Safety and Monitoring Board preparation, and grant preparation.
Required Skill/ability 3: Ability to produce high quality work and track deliverables. Must demonstrate excellent organizational skills, attention to detail, efficiency, and critical thinking.
Required Skill/ability 4: Experience in training and supervision of research staff with high degree of emotional intelligence to recognize when escalation and de-escalation is appropriate.
Required Skill/ability 5: Ability to communicate effectively with research staff, physicians, sponsors, colleagues and other stakeholders. Demonstrable technical expertise with advanced ability to work across data platform such as Excel, Redcap, Powerpoint etc. Must have proficiency in use of EPIC.
Preferred Education: Bachelor's degree or equivalent with 3 years of professional clinical or clinical research experience at minimum. Advanced budget management and accounting experience is a plus.
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: Research Associate 3, HSS
University Job Title: Project Manager
Preferred Education, Experience and Skills: Bachelor's degree or equivalent with 3 years of professional clinical or clinical research experience at minimum. Advanced budget management and accounting experience is a plus.
Master's Degree in a related discipline and four years of experience or an equivalent combination of education and experience.
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.
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