Clinical Research Manager

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Overview
Working at Yale means contributing to a better tomorrow. The Yale Stress Center conducts cutting-edge interdisciplinary research that focuses on developing and testing novel treatments to reverse the destructive effects of stress on integrated brain, body and behaviors. Our goal is to develop new prevention and treatment strategies to decrease the harmful impact of stress on health and increase our ability to regulate stress, promote health and wellness, and have better self-control over addictive behavior.

The Research Associate 2 will manage, oversee and implement multi-faceted translational research projects operated through the Stress Center in the Department of Psychiatry. This position will serve as the primary interface between clinical and experimental studies and also for clinical trials in alcohol and substance use disorders. With a high degree of independence, the Research Associate 2 will coordinate with University and hospital departments as well as collaborating research laboratories to successfully collect, process, distribute and analyze multi-level subjective, biological, cognitive and outcome specimens and clinical outcome data.  Responsibilities will include patient recruitment, clinical diagnostic assessments and delivery of interventions, procurement and distribution of specimens, data management and analysis. The research associate will assist in development, implementation and maintenance of original research protocols and the related quality assurance and study monitoring procedures as well as preparation of manuscripts, presentations and publications.  The Research Associate 2 will be responsible for maintaining research records, including source documents and case report forms, entering data into electronic data capture systems, reporting adverse events, providing sponsors with requested clinical and regulatory information, and resolving data queries in a timely manner. Laboratory responsibilities include coordinating laboratory specimen collection, storage, and shipment and maintaining laboratory equipment and supplies. Other responsibilities include managing study supplies, drug accountability, and assisting with monitor visits. The Research Associate 2 will assist with the preparation of research protocols, and protocol renewals and amendments for submission to the institutional review board (IRB). Data management responsibilities are also included such as cleaning and verifying data, creating summary reports and tables, reporting on clinical trials.gov and FDA reporting and summary data for presentations.

The Yale Stress Center also has post-baccalaureate research associates. The Research Associate 2 will share in the training and supervision of these individuals and will generally serve as the lead coordinator of the existing clinical research studies at the YSC.

Required Skills and Abilities
1. Clinical Research Proficiency and Compliance: Proven experience with clinical studies.
2. Excellent oral, written, organizational and interpersonal skills, ability to work independently. Experience with computers, work processing, Excel and web-based data collection such as REDCAP.
3. Excellent oral and written communication skills.  Ability to interact with successfully with patients, staff and faculty in a clinical research and academic environment. .
4. Ability to work independently as well as function effectively within a team.
5. Strong attention to detail, excellent organizational skills, and the ability to prioritize and multitask.
 

Principal Responsibilities

 

1.Manages and monitors policies, practices and procedures of clinical research staff responsible for the implementation, management (including protocol updates / amendments), and quality conduct of clinical trials according to study protocols and Good Clinical Practice guidelines. 
2. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research staff. Assigns and manages workload and provides estimates for individual project staffing needs using the Staffing Acuity Tool. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters. 
3. Serves as a subject matter expert on protocol management and study subject recruitment. Provides support and guidance to the study team to develop and maintain study specific materials (e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals). 
4. Collaborates with CTO Clinical Trials Project Manager and Principal Investigator (PI) on assessment and operational implementation of highly complex trials clinical research protocols within Oncology Disease Group, including feasibility, identifying accrual targets, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Serves as a liaison to the study sponsor, regulatory agencies, investigators, and clinical teams. 
5. Ensures infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulations while ensuring participant safety. Includes assigning research support staff.
6. Manages oversight of protocol conduct and ensures that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements and follows directives that may be required to ensure University compliance with congruency review and reporting requirements. 
7. Develops, implements, and champions internal practices that ensure compliance with federal requirements. 
8. Serves as a critical resource before and during interim monitoring visits, internal audits and external audits/inspections. Works with study monitors to ensure compliance with study requirements. Analyzes and interprets reports/findings from retro/prospective audits with investigators and advises and monitors appropriate action plan. Responsible for contributing to formal responses to audit and inspection report findings that relate to clinical operations findings. 
9. Contributes to the review and refinement of CTO standard operating procedures (SOPs) and assists with SOP training. 
10. Coordinates with Clinical Trials Project Manager to liaise between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned Oncology Disease Group or Smilow Care Center. 
11. Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring 
12. Other duties as assigned 
 

Required Education and Experience

Bachelor’s degree in a health-related discipline, or other related field and a minimum of five(5) years of experience in clinical trials research or the equivalent combination of education or experience
 

Job Posting Date

06/10/2026

Job Category

Manager

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (M5)

Salary Range

$68,000.00 - $120,500.00

Time Type

Full time

Duration Type

Staff Fixed Duration (Fixed Term)

Work Model

On-site

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

This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air.  HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.

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.