Clinical Research Coordinator 1 (Spanish Speaking)

About the role

The Clinical Research Coordinator I (CRC I) supports clinical trials in the Department of OBGYN and Division of Maternal-Fetal Medicine. This role involves overseeing clinical activities, managing patient recruitment, and ensuring compliance with protocols.

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.
• 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.
• Maintains awareness of federal and state regulations, and local policies for new guidance, updates, or policies.
• Performs other duties as assigned.

Requirements

• Demonstrated experience with patient recruitment and obtaining informed consent.
• Fluent in English and Spanish.
• Comfortable with learning/doing Phlebotomy and handling human specimens.
• Knowledge of clinical research terminology and regulatory requirements, including GCP, FDA regulations, and HIPAA.
• Self-directed with the ability to manage multiple studies independently.
• Strong professionalism, judgment, and ability to handle confidential information.
• Advanced interpersonal and communication skills, both written and oral.

Preferred Skills And Abilities

• Knowledge of clinical trial management systems and experience with electronic medical records (EMR).
• Women’s Health (OBGYN) experience preferred.
• Demonstrated experience in clinical trials coordination.
• Certification from ACRP/SOCRA or equivalent is preferred.
• Ability to manage multiple tasks in a fast-paced environment with strong attention to detail.

Education and Experience

A 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 License(s) or Certification(s)

Required License(s) or Certification(s): Physical Requirements: Job Posting Date 08/27/2026 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 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 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).