Clinical Research Coordinator I

J ob Title: Clinical Research Coordinator I FSLA Classification: Non - Exempt Reports to: Site Operations Manager Job Summary/ Objective: The Clinical Research Coordinator I is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Site Operations Manager.

Essential Functions: Overseeing Clinical Trials: Ensure trouble-free running of clinical trials. Monitor study participants’ health throughout the trial. Compile reports summarizing the success or failure of drugs, technologies, or medical procedures. Oversee 1-2 trials Data Collection and Analysis: Collect data obtained from research. Analyze research data. Participant Interaction: Communicate with study participants regarding study objectives.

Administer questionnaires. Monitor participant adherence to study rules. Collaboration and Compliance: Liaise with laboratories Monitor study compliance with protocols and ethical standards. Ensure adherence to regulatory requirements. Record Keeping: Maintain research records, including case report forms and drug dispensation records. Direct specimen collection, labeling, storage, and transport. Logistics and Supplies: Ensure all necessary equipment and supplies are in stock and functional.

Education/Experience/Skills: Education: Bachelor's degree preferred in health-related field Experience: 1 year experience in Clinical Research Skills: (please refer to the Helios Upskilling Guide for the complete list of all skills required for this role) Regulatory Filing and accessing documents, Study Submission Assistant Finance Stipend payments Subject Interaction Recruit, interview, screen, enroll, and randomize subjects Obtain Informed Consent Collect medical history Conduct study visits Administrative Source documentation EDC Query resolution AE/SAE documentation and reporting Address protocol deviations Order supplies Clinical Skills Phlebotomy Vital Signs ECG Working Conditions / Physical Demands: Standard operating hours are Monday through Friday, 8:00 a.m.

to 5:00 p.m. May be required to complete job-related tasks outside of that time frame in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare, and communicate appropriate reports.

Travel required: as needed (travel to IM’s may be required)