Clinical Research Coordinator

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Overview

The Clinical Research Coordinator will be working in the Department of Psychiatry as the lead coordinator for an NIH funded studies and Industry Clinical Trials. The study coordinator will oversee all study aspects and manage all study goals and tasks, assuring all aspects of the research study are on track and meet all regulatory requirements. CRC will also be working on different studies including clinical trials for the PI that include screening, consent, blood drawing, hemodynamic monitoring, processing of blood drawing as specified in protocols, and follow ups. Study protocol may involve processing of blood samples as well as handling and shipment procedures. For additional study specific procedures and educational interventions, CRC will be trained in the study protocols before execution. Carries out research within the scope of the established study protocol. Adheres to all human subject’s regulations as defined by Yale University and the federal government that pertain to research studies. Develops criteria for admission of study subjects based on goals and objectives of project. Determines potential sources of funding and prospective partnerships. Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder. Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding. Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location. Works independently to develop manage and organize multi-site studies. Serves as primary coordinator between university, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources. Performs descriptive and multivariate statistical analyses of data, using computer software. Designs and implements quality control measures to ensure accurate collection and processing of data. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Skills and Abilities

1. Self-Motivation, Organization, and Detail-Orientation: Demonstrates self-motivation, independence, consistency, and reliability. Shows excellent attendance, punctuality, and organizational skills. Pays close attention to detail and communicate effectively.

2. Effective Under Pressure with Communication and Leadership: Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively. Demonstrates strong oral and written communication skills, along with leadership qualities.

3. Technical Proficiency in Research Tools: Exhibits proficiency in Microsoft Office and familiarity with electronic data collection tools such as iPads and software like Endnote and Adobe.

Preferred Skills and Abilities

1. Project management experience preferred.

2. Proven experience working in a VA setting.

3. Proven experience preparing IRB protocols, amendments, and progress reports.

4. Proven experience developing and managing original HIC/IRB submissions; collaborates with PIs on major revisions based on knowledge of science and research goals; plans and implements changes.

5. Proven experience with SPSS and REDCap.

Principal Responsibilities

1. Serves as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials. Serves as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies and non-therapeutic trials. 3. Contributes to study feasibility reviews and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes for low to moderately complex clinical trials and non-therapeutic trials. 4. Ensures low to moderately complex study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. 5. Identifies instances of noncompliance and deviations from protocol and works with manager to analyze and advises noncompliance and deviations to the appropriate parties. 6. Advises Principal Investigator oversight on low to moderately complex clinical trials and non-therapeutic trials by providing updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required. 7. Analyses, documents and conveys study data on low to moderately complex clinical trials and non-therapeutic trials. Coordinates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner. 8. Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations on low to moderately complex clinical trials and non-therapeutic trials. 9. Assesses trial execution for assigned low to moderately complex trials and non-therapeutic trials and identifies areas that need improvement or that require correction and provides education and/or recommendations, as needed. 10. Collaborates with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensures implementation and adherence to stated plan for low to moderately complex trials and non-therapeutic trials.  11. Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education. 12. Participates in interim monitoring visits and internal audits. 13. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies.  14. Performs other duties as assigned. Required Education and Experience Bachelor’s degree in a health-related discipline, or other related field and one (1) year of clinical research experience, or the equivalent combination of education or experience. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required.  Experience must indicate the ability to work with minimal supervision in a team environment. Required License(s) or Certification(s) Required License(s) or Certification(s): Physical Requirements Physical Requirements:

Job Posting Date

11/12/2026

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

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

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

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.