Clinical Research Manager

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Overview

The Clinical Research Manager (CRM) oversees research staff in the Department of Emergency Medicine to ensure that clinical trials and other human subjects research projects are conducted in alignment with the study protocols and applicable policies and regulations while maintaining participant safety. Under the direction of the Assistant Director of Research and departmental research leadership, the CRM manages staff recruitment, training, retention, and performance to ensure quality and accountability. The CRM operates in a multidisciplinary environment, collaborating internally and externally with professionalism and respect.

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.

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. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters.

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).

Collaborates with departmental Principal Investigators(PI) on assessment and operational implementation of highly complex clinical research trial protocols, including feasibility, identifying accrual targets, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process.

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.

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.

Develops, implements, and champions internal practices that ensure compliance with federal requirements.

Contributes to the review and refinement of departmental standard operating procedures (SOPs) and assists with SOP training.

Coordinates, oversees and participates in meetings including but not limited to pre-study Visits, Site Initiation Visits, Monitoring, etc.

Other duties as assigned, including ability to cover ED recruitment shifts based on operational need.

Schedule: The Emergency Medicine Clinical Enroller program provides 24/7 recruitment and consenting services. This position  requires flexibility to support 24/7 support including evenings and weekends. The standard schedule is 37.5 hours Mon-Friday with on-call evening and weekend hours as needed to provide coverage for research staff.

Required Skills and Abilities

1. Demonstrated experience supervising staff in a clinical research environment.

2. Extensive knowledge of Good Clinical Practice guidelines and the ability to interpret federal, state, and institutional policies and complex clinical trial protocols. Proven experience obtaining informed consent and with participant recruitment. ACRP/SOCRA/CCRPS Certificate or willing to get within 1 year.

3. Ability to assess and ensure appropriate infrastructure for clinical trials, considering clinical, physical, technological, and staff resources.

4. Strong communication, leadership, and team-building skills, including resource management and effective problem-solving.

5. Ability to manage multiple projects simultaneously, balancing priorities and deadlines, and reporting on project deliverables effectively.

PLEASE DISREGARD PRINCIPAL RESPONSIBILITES BELOW. FOCUS ON OVERVIEW AND SKILLS ABOVE!

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

10/28/2026

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

Benefits

A general description of the benefits to be offered with this Managerial & Professional position is available at:

Yale Benefits

Time Type

Full time

Duration Type

Staff

Work Model

Hybrid

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 basedon 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 throughtheir 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.