STARS Requisition number
85101BR
Posting Position Title
Clinical Trials Program Specialist
Essential Duties
1. Manages processing, tracking, and filing of study documents and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, and Instructions for Use. 2. Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents. 3. Collates aggregate study data into reports for external audiences including data and safety monitoring groups, regulatory authorities, and project funders. 4. Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 5. Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems, and regulatory document systems. 6. Assists in implementation of improvements and, solutions and assistance as needed under the supervision of senior team members. 7. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 8. Assists in the development and preparation of budgets. 9. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 10. Ensures compliance with University and federal regulations as they apply to the assigned departments. 11. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 12. May perform other duties as assigned.
Required Education and Experience
Bachelor’s Degree in related field and two year of related experience or an equivalent combination of education and experience.
Weekend Hours Required?
Occasional
Evening Hours Required?
Occasional
Dept/Section URL
Click here for more information
Duration Type
Regular
Work Week
Standard (M-F equal number of hours per day)
University Job Title
Clinical Trials Project Specialist
Worksite Address
310 Cedar Street
New Haven, CT 06510
Work Location
Medical School Campus
Drug Screen
No
Health Screening
No
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Searchable Job Family
Clinical, Research/Support
Total # of hours to be worked:
37.5
Position Focus:
An Associate Professor/Principal Investigator in the Reproductive Sciences Division, Department of Obstetrics, Gynecology & Reproductive Sciences, seeks a Clinical Trials Specialist to assist in a new clinical study start up and two ongoing clinical-translational studies in metabolic and gynecology research. The activities of this position include direct patient and participant contact, coordinating a re-contacting campaign, recruiting and consenting participants, and liaising with the Yale Institutional Review Board (IRB) and the Yale Centers for Clinical Investigation (YCCI).
Preferred Education, Experience and Skills:
Experience with communicating through social media. Management skills in implementing large projects. Ability for conversational Spanish, or fluency in Spanish.
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.
EEO Statement:
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Compensation Grade
Administration & Operations
Compensation Grade Profile
Supervisor; Senior Associate (22)
Bargaining Unit
None - Not included in the union (Yale Union Group)
Supervisory Organization
Obstetrics & Gynecology - Endocrinology
Time Type
Full time
Required Skill/Ability 1:
Professionalism, good judgement, and ability to work with confidential material and protected health information. Strong interpersonal, oral and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.
Required Skill/Ability 2:
Self-directed with the ability to work, plan, research and manage multiple studies with minimal supervision, on a flexible schedule and with best practice expertise for low to moderately complex trials and non-therapeutic trials.
Required Skill/Ability 3:
Ability to manage multiple/diverse low to moderately complex trials and non-therapeutic trials studies simultaneously. Proven ability to multi-task and remain focused in a fast-paced environment.
Required Skill/Ability 4:
Analytical in nature and assignments range from low to moderately complex to co-support planning. Decisions are guided by clear to obscure guidelines and policies and can have a moderate short-term impact to the areas of which they are accountable.
Note
Yale University is a tobacco-free campus
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines
Wage Ranges
Click here to see our Wage Ranges
Work Model
Hybrid
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