Reporting to Principal Investigator for clinical studies at the West Haven VA with experience in clinical trials, candidate’s responsibilities will include recruiting and monitoring of study participants in compliance with good clinical practice guidelines. Will participate in the education of the medical staff regarding the purpose of clinical trials and potential benefits to veteran population. Will contact study participants with appointment reminders and for follow-up as necessary. Will participate in conference calls and maintain ongoing communication with the Chairman’s Office and with the Cooperative Studies Program Office. Department URL Address: Click here for more information Principal Responsibilities 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 Education and Experience Master’s Degree in a related discipline.
Four years of related experience or an equivalent combination of education and experience. Required Skill/Ability 1: Demonstrated experience in clinical trials. Required Skill/Ability 2: Proven experience with writing and publishing abstracts, publications and manuscripts. Required Skill/Ability 3: Demonstrated experience with recruitment of study participants. Required Skill/Ability 4: Ability to perform administrative tasks including accurate and timely completion of case reports. Required Skill/Ability 5: Proven experience with presenting talks, seminors or other oral presentations used in scientific studies. Weekend Hours Required? No Evening Hours Required? No Drug Screen No Health Screening No Background Check Requirements All external candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle and credit checks based on the position description and job requirements. All offers are contingent on successful completion of a background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process. Additional Background or Health Screening Requirements: Selected incumbent must have successful completion of a federal and/or state background check investigation, in addition to the University background check. 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.
Yale University - 17 months ago
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