Clinical Research Coordinator 1

Yale University is hiring a Clinical Research Coordinator 1 to support clinical trials and non-therapeutic studies in psychiatry, neuroscience, and substance use. The role coordinates study operations, participant recruitment, regulatory compliance, data management, and collaboration with investigators and research teams.

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education
• Participates in interim monitoring visits and internal audits
• Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies
• Performs other duties as assigned

Preferred

• Master's-level coursework or degree in public health, psychology, neuroscience, or a related field preferred
• Proven experience in psychiatric, neuroscience, substance use, or clinical research
• Proven experience with IRB/regulatory submissions, participant recruitment and screening, informed consent, REDCap or similar research databases, and preparation of research reports or presentations
• Familiarity with EEG, VR, biospecimen workflows, or other clinical research technologies is a plus
• Strong interest in translational mental health research and the development of novel biomarkers and treatments
• Public Health
• Psychology
• Neuroscience
• Psychiatric Research
• Substance Use Research
• Regulatory Submissions
• Research Databases
• Research Report Preparation
• Research Presentations
• EEG
• Virtual Reality
• Biospecimen Workflows
• Clinical Research Technologies
• Translational Mental Health Research
• Biomarker Development
• Treatment Development
• Interest in Mental Health Research

Company

• Research university focused on education and knowledge advancement
• New Haven, Connecticut, USA
• https://www.yale.edu/
• Founded in 1701
• 10001+ employees

Qualifications

• Strong organizational and project-management skills, with the ability to coordinate multiple research studies, priorities, deadlines, and study documents with close attention to detail
• Demonstrated ability to support human subjects research, including participant recruitment, screening, scheduling, informed consent, study visits, and professional communication with research participants
• Proven experience with clinical research regulatory and compliance activities, including preparation and maintenance of IRB submissions, amendments, study binders/files, and protocol documentation
• 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
• Excellent written, verbal, and interpersonal communication skills, prepare reports and presentations, and collaborate effectively with multidisciplinary research teams
• 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
• Master's-level coursework or degree in public health, psychology, neuroscience, or a related field preferred
• Proven experience in psychiatric, neuroscience, substance use, or clinical research
• Proven experience with IRB/regulatory submissions, participant recruitment and screening, informed consent, REDCap or similar research databases, and preparation of research reports or presentations
• Familiarity with EEG, VR, biospecimen workflows, or other clinical research technologies is a plus
• Strong interest in translational mental health research and the development of novel biomarkers and treatments
• 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.

Required skills

• Clinical Practice (GCP), Clinical Research, Data Analysis, Federal Regulations, Human Subjects Research, IRB Submissions, Informed Consent, Psychiatric Research, REDCap, Research Data Management

Preferred skills

• (188), (287), (328), (413), *2026, 2022, 2023, 2024, 2025, 4.2, Accounting and Finance, Arts and Entertainment, Creatives and Design, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Education and Training, Engineering and Development, Glassdoor, H1B Sponsorship, Human Resources, Legal and Compliance, Management and Executive, Marketing, New Haven, Connecticut, USA, Public Sector and Government, Represents job field similar to this job, Sales, Trends of Total Sponsorships, https://www.yale.edu

Experience

• 1+ years