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Clinical Research Coordinator

System One Holdings, LLC

Clinical Research CoordinatorJoin a busy, onsite clinical research site in Dallas, TX as a Clinical Research Coordinator, supporting vaccine and other clinical trials by coordinating study visits, assisting with informed consent, maintaining source documentation, and ensuring compliance with GCP/SOPs. You'll partner closely with the PI, research staff, and participants to support screening, data entry, safety reporting, and day-to-day study operations with a strong focus on quality and patient experience.Responsibilities:Assist in the coordination and execution of clinical research protocols under the supervision of the PI and senior research staff.Conduct screening visits to collect medical history & other information from study participants.Assist with informed consent and enrollment of study participants in accordance with protocol requirements and ethical guidelines.Coordinate and schedule study visits, procedures, and follow-up activities with study participants and clinical teams.Collect, record, and maintain accurate clinical research data and source documentation in compliance with regulatory and institutional standards.Communicate with study participants to provide education, answer questions, and support adherence to study requirements.Monitor study progress and report adverse events, protocol deviations, and other study-related issues to the research team.Adhere to site standard operating procedures (SOPs) and Good Clinical Practice (GCP) guidelines.Draw, process, and ship laboratory specimens, including the handling of dangerous goods, in accordance with regulations (if qualified.)Scan, upload, file, and maintain organized study records and documentation.Apply critical thinking skills to support efficient study operations and problem resolution.Perform other duties as assigned.Requirements:High school diploma or equivalent required; an associate's degree or higher in a health-related field preferred.Basic knowledge of clinical research strongly preferred.Medical terminology & patient care experience required.Strong organizational, time management, and attention-to-detail skills with the ability to manage multiple priorities.Ability to communicate clearly and professionally with diverse populations.Ability to work collaboratively in a fast-paced, team-oriented environment.Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines strongly preferred.Experience with participant screening and the informed consent process strongly preferred.Proficiency with electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, and PowerPoint) preferred.Medical Assistant (MA) certification preferred.Current CPR/BLS certification preferred.Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification preferred.

Vacancy posted 4 days ago
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