CRC - Clinical Research Coordinator

Revival Research Institute, LLC•Richardson, TX

7d•Onsite

About The Position

Revival Research Institute is hiring an experienced, site-based Clinical Research Coordinator to independently manage assigned industry-sponsored interventional trials from site initiation through close-out. This is not an entry-level position. Coordinators manage multiple concurrent studies and support Investigators and clinical staff with study-related work. The role includes screening, recruiting, and enrolling participants; obtaining informed consent; conducting protocol visits; collecting, processing, and shipping research specimens; maintaining source documents and entering data into EDC systems; hosting monitoring visits and resolving findings; managing regulatory documents and study quality; communicating with sponsors, CRAs, labs, and vendors; managing investigational product; and maintaining current regulatory knowledge and training. The coordinator also communicates with participants and their families, supports retention, and protects confidentiality under HIPAA. This position is based on-site in Denton, Texas.

Requirements

At least 2 years of experience as a Clinical Research Coordinator at a research site, serving as primary coordinator on industry-sponsored interventional trials; academic-only, registry-only, and observational or minimal-risk experience does not meet this requirement.
Demonstrated experience independently obtaining informed consent on interventional protocols.
Hands-on experience with EDC platforms.
Demonstrated experience hosting monitoring visits and independently resolving monitoring findings.
Working knowledge of ICH-GCP E6(R3), 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
Proficiency in conducting physical assessments, including vital signs and 12-lead ECG acquisition.
Master's degree in a health-related field or equivalent clinical research site experience.
Strong computer proficiency, including Microsoft Word, Excel, and Outlook.
Excellent verbal and written communication skills.
Ability to work independently, manage competing protocol deadlines, and take ownership of assigned studies.
Ability to work on-site in Denton, Texas.

Nice To Haves

Current phlebotomy competency.
IV certification.

Responsibilities

Screen, recruit, and enroll candidates by assessing them against inclusion and exclusion criteria.
Independently obtain informed consent for interventional protocols in accordance with ICH-GCP and 21 CFR Part 50.
Conduct study visits according to protocol and collect, process, and ship research specimens, including IATA-regulated shipments where applicable.
Obtain, review, and maintain contemporaneous source documents.
Enter data into EDC systems within sponsor-specified timelines and resolve queries within protocol guidelines.
Host monitoring visits and resolve CRA findings and follow-up letters.
Organize and maintain complete trial documents and correspondence in regulatory binders and eRegulatory systems.
Implement and maintain study-level quality control and assurance methods, keeping files inspection-ready.
Serve as the day-to-day contact for sponsors, CRAs, central labs, and IRT/IWRS vendors.
Prepare and submit regulatory documents, including amendments, continuing reviews, adverse and serious adverse event reports, and protocol deviation reports, within required reporting windows.
Manage investigational product receipt, dispensing, reconciliation, storage conditions, and temperature excursion documentation.
Maintain current working knowledge of ICH-GCP E6(R3), applicable FDA regulations, and evolving sponsor and site practices, as well as required certifications and training.
Communicate with participants and their families throughout the study, support retention across visit schedules, and protect participant confidentiality in accordance with HIPAA.