Clinical Research Coordinator I

Responsibilities

Coordinate all aspects of assigned clinical trials from site initiation to study close-out Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs Manage subject recruitment, informed consent, and retention strategies Ensure timely data entry and resolution of EDC queries Report and follow up on all adverse events, serious adverse events, and deviations Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders Prepare for and participate in monitoring visits, audits, and inspections Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained) Attend investigator meetings and provide cross-functional support as needed Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control

Requirements

Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP Previous experience as a Clinical Research Coordinator Industry-sponsored trial experience strongly preferred (vaccine study experience a plus) Familiarity with electronic data capture (EDC), IVRS, and other trial platforms Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures Proficiency in medical terminology and clinical documentation practices Strong interpersonal, verbal, and written communication skills Organized, detail-oriented, and capable of managing multiple priorities Proficient in Microsoft Office and other clinical research systems Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind. Headlands Research is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Need Assistance? Headlands Research is committed to providing access and reasonable accommodation in its employment for individuals with disabilities. To request disability accommodation in the application process, contact recruiting@headlandsresearch.com for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.