Clinical Research Coordinator 2

Overview The Clinical Research Coordinator II (CRC II) is responsible for providing research services to patients participating in clinical trials. Key responsibilities include overseeing, planning, tracking, and ensuring clinical activities for study participants are conducted in accordance with approved protocols. These activities include patient screening, eligibility determination, registration, and other protocol milestones. The position works within a multidisciplinary environment, collaborating with internal and external colleagues to ensure professionalism and effective communication. The CRC II will have direct patient contact and manage the clinical and operational aspects of moderately to highly complex study protocols. Required Skills And Abilities Strong professionalism, judgment, and ability to handle confidential information. Knowledge of clinical research terminology and regulatory requirements, including GCP, FDA regulations, and HIPAA. Self‑directed with the ability to manage multiple studies independently. Advanced interpersonal and communication skills, both written and oral. Ability to manage multiple tasks in a fast‑paced environment with strong attention to detail. Preferred Skills And Abilities Knowledge of clinical trial management systems and experience with electronic medical records (EMR). Oncology experience preferred. Bachelor’s degree in a scientific, health‑related, or business administration field preferred; advanced research training is a plus. Demonstrated experience in clinical trials coordination. Certification from ACRP/SOCRA or equivalent is preferred. Principal Responsibilities Serve as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols. Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration. Contribute to study feasibility reviews and make recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes. Ensure study protocols are adhered to, oversee the maintenance of accurate documentation, recruitment of study participants and regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. Identify instances of noncompliance and deviations from protocol and report and advise noncompliance and deviations to the appropriate parties. Advise Principal Investigator through updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required. Analyze, document and convey study data. Collaborate with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner. Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations. Assess trial execution program wide and identify areas that need improvement or that require correction and provide education and/or recommendations, as needed. Collaborate with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensure implementation and adherence to stated plan. Collaborate with the Quality Education Unit to contribute to the design of CRC trainings and continuing education. Participate in interim monitoring visits, internal audits, and external audits/inspections. Oversee the work and advise on protocol management and recruitment to CRC I development. Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies. Perform other duties as assigned. Required Education and Experience Bachelor’s degree in a health‑related discipline, or other related field and two (2) years of clinical research experience, or the equivalent combination of education or experience. Minimum of one (1) year experience in clinical trials coordination. 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. Salary Range : $65,000.00 - $101,000.00 Time Type : Full time 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. Note: Yale University is a tobacco‑free campus. EEO Statement 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). #J-18808-Ljbffr Yale University