YCCI Clinical Trials Project Specialist

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Overview
As a member of the clinical trials project management team for clinical research, the Clinical Trials Project Specialist position supports clinical research project management and assists with interdisciplinary research activities. The role supports a culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including assisting in coordinating initiatives which identify, prevent, and appropriately mitigate multisite trials and FDA 21 CFR Part 11 research system compliance risk, support efforts to ensure YSM, YM, YNHH compliance efforts align with the university’s broader compliance strategy and framework. The position works effectively with other team members and units/departments within the university such as biostats (YCAS), EHR research team (JDAT), Human Subjects Protections (HRPP), industry contracting team, and finance; clinical trials sponsors and vendors; and with research teams at other academic centers. This position will be partially funded by the sponsored awards it supports. 

Principal Responsibilities
1.    Manages processing, tracking, and filing of study documentation and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, Instructions for Use, and other essential study documents.  
2.    Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents within a Trial Master File (TMF). 
3.    Coordinates Data and Safety Monitoring Board (DSMB) operations for assigned studies, including developing timelines for report preparation, coordinating data collection and review, facilitating DSMB meetings, ensuring timely submission of materials, documenting outcomes, and monitoring implementation of DSMB recommendations and action items.
4.    Collates aggregate study data into reports for external audiences including Data and Safety Monitoring Boards (DSMBs), regulatory authorities, sponsors, and project funders. 
5.    Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 
6.    Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems (REDCap and Advarra EDC), and regulatory document systems (Advarra eReg).  
7.    Assists in the identification, development, implementation of process improvements and operational solutions and assistance as needed under the supervision of senior team members. 
8.    Manages technology resources, including system requirements, user access, and system requirements for the assigned departments. 
9.    Provides administrative and project coordination support across multiple projects to ensure timely completion of deliverables. 
10.    Ensures compliance with University and federal regulations as they apply to the assigned departments. 
11.    Assists in reviewing, implementing and maintaining University and departmental policies and procedures related to the research operations and administrative functions of the department. 

Required Education, Skills and Abilities

1. Knowledge of ICH Good Clinical Practice (GCP) guidelines, and federal, state, and local guidelines pertaining to clinical research.

2. Flexibility in work focus; ability to switch among several different projects without any adverse effects.

3. Strong interpersonal skills to interact effectively and represent the school well with faculty, and study team members. 

4. Excellent oral and written communication skills; very effective listening and feedback abilities.

5. Demonstrated organizational skills. Working knowledge of MS Office.

Preferred Education, Experience, Skills and Abilities

1. Bachelor’s degree in related field or equivalent combination of education and experience.

2. Work experience in regulatory affairs, clinical trials coordination and/or management.

Principal Responsibilities

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. Required License(s) or Certification(s) Required License(s) or Certification(s): Physical Requirements Physical Requirements:

Job Posting Date

09/15/2026

Job Category

Professional

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (22)

Salary Range

$61,500.00 - $91,875.00

Time Type

Full time

Duration Type

Staff

Work Model

Remote

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.

Health Requirements

Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.

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 position. Employees will be assigned specific job-related duties through  their hiring department.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy 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).

Note

Yale University is a tobacco-free campus.