CRC - Clinical Research Coordinator

Revival Research Institute, LLC conducts industry-sponsored clinical trials across multiple U.S. sites. The Clinical Research Coordinator will independently manage assigned interventional study protocols from site initiation through close-out, coordinating screening, enrollment, study visits, data entry, regulatory submissions, monitoring activities, investigational product accountability, and participant communication.

Responsibilities

Screening, recruitment, and enrollment. Pre-screen candidates against inclusion/exclusion criteria, independently obtain informed consent on interventional protocols in accordance with ICH-GCP and 21 CFR Part 50, and conduct study visits per protocol. Collect, process, and ship research specimens, including IATA-regulated shipments, where applicable

Data and monitoring. Obtain, review, and maintain source documents contemporaneously. Enter data into EDC within sponsor-specified timelines and resolve queries within guidelines provided in the protocol. Host monitoring visits, and drive CRA findings and follow-up letters through to resolution

Regulatory and quality. Own the organization and completeness of all trial-related documents and correspondence across regulatory binders and eRegulatory systems. Implement and maintain quality control and assurance methods at the study level, and maintain inspection-ready files at all times

Sponsor and IRB communication. Serve as day-to-day point of contact for sponsors, CRAs, central labs, and IRT/IWRS vendors. Independently prepare and submit regulatory documents including amendments, continuing reviews, adverse and serious adverse event reports within required reporting windows, and protocol deviation reports

Investigational product accountability. Manage IP receipt, dispensing, reconciliation, storage conditions, and temperature excursion documentation in accordance with the protocol and sponsor requirements

Professional and technical knowledge. Maintain current working knowledge of ICH-GCP E6(R3), applicable FDA regulations, and evolving sponsor and site practices. Maintain certification and required training

Participant communication and confidentiality. Communicate with research participants and their families throughout the study lifecycle, support retention across visit schedules, and protect participant confidentiality in accordance with HIPAA

Preferred

Current phlebotomy competency, as well as IV certification, is preferred

Phlebotomy Competency

IV Certification

Company

Clinical research organization conducting phase I-IV trials

Southfield, Michigan, USA

https://revivalresearch.org/

Founded in 2015

201-500 employees

Qualifications

2+ years as a Clinical Research Coordinator at a research site, serving as primary coordinator on industry-sponsored interventional trials. Academic-only, registry-only, or observational/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 resolving monitoring findings independently

Working knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA

Proficiency in conducting physical assessments, including comfort with 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 Office (Word, Excel, Outlook); excellent verbal and written communication; ability to work independently, manage competing protocol deadlines, and assume ownership of assigned studies

Ability to work on-site in Denton, Texas

Current phlebotomy competency, as well as IV certification, is preferred

Required skills

Industry-Sponsored Interventional Clinical Trials, Informed Consent, Electronic Data Capture (EDC), Clinical Trial Monitoring, ICH-GCP E6(R3), HIPAA, Phlebotomy, Intravenous (IV) Certification, Physical Assessments, Vital Signs Measurement, 12-Lead ECG Acquisition, Microsoft Office

Preferred skills

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Experience

2+ years