Clinical Research Coordinator 1

Yale University; West Haven (CT); On-site; USD 62,000 - 92,000; Full time

Job summary

Yale University in West Haven, CT is seeking a Research Associate I to support clinical research in a psychiatry/neuroscience lab. You will coordinate day-to-day activities, assist with participant recruitment, consent, and visits, and manage data and regulatory files.

The role requires strong organizational skills, experience with human subjects research, and proficiency in data management and reporting. This is an on-site position supporting IRB submissions and study documentation.

Qualifications

• 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.

Responsibilities

• Serves as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non-therapeutic trials.
• 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.
• 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.
• 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.
• Identifies instances of noncompliance and deviations from protocol and works with manager to analyze and advises noncompliance and deviations to the appropriate parties.

Skills

Organizational skills

IRB knowledge

REDCap

Data management

Communication skills

Education

Bachelor’s degree in health-related discipline

Tools

REDCap

Job description

950 Campbell Avenue, Bldg 34, West Haven, Connecticut

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!

Overview

The Research Associate I will support clinical research in the Ranganathan Research Lab at the intersection of psychiatry, neuroscience, and substance use. The position will contribute to studies examining psychiatric disorders, including schizophrenia and depression, and research involving cannabis, cannabinoids, ketamine, and other novel therapeutic approaches. Responsibilities include coordinating day-to-day research activities; assisting with participant recruitment, screening, scheduling, informed consent, and study visits; collecting, entering, managing, and reviewing research data; maintaining study documentation and regulatory files; supporting IRB submissions, amendments, continuing reviews, and other regulatory requirements; assisting with biospecimen and/or neurobehavioral research procedures as applicable; conducting literature reviews and contributing to data analyses and development of reports, presentations, and manuscripts; and collaborating with investigators, clinicians, research staff, and external partners. The Research Associate will help ensure that studies are conducted accurately, efficiently, and in accordance with approved protocols, institutional policies, and human subjects research requirements. They will demonstrate independent decision making by identifying issues, evaluating the available information (e.g. regulatory guidelines), and implementing appropriate solutions within the scope of the role.

Required Skills and Abilities

• 1. Strong organizational and project-management skills, with the ability to coordinate multiple research studies, priorities, deadlines, and study documents with close attention to detail.
• 2. Demonstrated ability to support human subjects research, including participant recruitment, screening, scheduling, informed consent, study visits, and professional communication with research participants.
• 3. Proven experience with clinical research regulatory and compliance activities, including preparation and maintenance of IRB submissions, amendments, study binders/files, and protocol documentation.
• 4. Proficiency with research data collection, entry, quality review, database management, and basic data analysis; ability to maintain accurate, confidential records and ability to work with REDCap or comparable systems.
• 5. Excellent written, verbal, and interpersonal communication skills, prepare reports and presentations, and collaborate effectively with multidisciplinary research teams.

Preferred Skills and Abilities

• 1. Master's-level coursework or degree in public health, psychology, neuroscience, or a related field preferred.
• 2. Proven experience in psychiatric, neuroscience, substance use, or clinical research.
• 3. Proven experience with IRB/regulatory submissions, participant recruitment and screening, informed consent, REDCap or similar research databases, and preparation of research reports or presentations.
• 4. Familiarity with EEG, VR, biospecimen workflows, or other clinical research technologies is a plus.
• 5. Strong interest in translational mental health research and the development of novel biomarkers and treatments.

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.

Job Posting Date 10/23/2026

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 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 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.

Note Yale University is a tobacco-free campus.

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