Clinical Research Coordinator I

Clinical Research Coordinator I Under the general supervision of a physician and the clinical and clinical research team in an outpatient setting, the Clinical Research Coordinator I (CRC I) is responsible for executing study-related activities from study startup through closeout. All tasks are conducted in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and USDP standards. The CRC I supports the Principal Investigator in the conduct of clinical trial visits, ensuring that participants are appropriately scheduled and that all protocol-specified procedures are completed accurately and in a timely manner. Duties and responsibilities include: Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits Assist the PI, and team when applicable, the informed consent process with patients and their families Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trials Maintain all source documents and investigational drug accountability records Enter source data into EDC efficient and accurately Maintain regulatory documents related to ISF Follow SOPs, policies, and procedures as set forth by the company Review EDC for accuracy and completion, and resolve queries as they arise Assists with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasks Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programs Ensure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsors Scans correspondence into EMR Practices safety, environmental, and/or infection control methods Assist clinical research manager in delegated tasks Performs miscellaneous job-related duties as assigned Process blood and urine samples in accordance with IATA and OSHA standards Prepare necessary documentation for SIV, IMV, COVs and other sponsor related meetings Qualifications: At least 1 year of research experience, preferred At least 1 year of direct patient experience, preferred Knowledge, skills and abilities requirements include: Meticulously detail oriented, professional attitude, reliable Organizational skills to support accurate record-keeping Ability to follow verbal & written instructions Interpersonal skills to work as a team with patients and outside parties Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations Mathematical and analytical ability for basic to intermediate problem solving Basic to intermediate computer operation Proficiency with Microsoft Excel, Word, and Outlook Specialty knowledge of systems relating to job function Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines Supervisory responsibilities: This position has no supervisory responsibilities. Benefits: Medical, Dental, & Vision 401k PTO & Paid Holidays Company Paid Life Insurance Employee Perks Program

Created: 2026-03-10