Job Description
About Revival Research Institute Revival Research Institute, LLC has been conducting industry-sponsored clinical trials since 2015. Headquartered in Metro Detroit, we operate sites across Michigan, Texas, Illinois, New Jersey, and North Carolina, and have been recognized nationally for the quality of the data we deliver to our sponsors.
About This Role This is not an entry-level position. We are hiring an experienced site-based coordinator who has independently run industry-sponsored interventional trials and can take ownership of assigned protocols from site initiation visit through close-out.
Clinical Research Coordinators at Revival coordinate and manage multiple concurrent studies and support the Investigators and clinical staff with study-related tasks including, but not limited to:
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.
Required 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.
- Current phlebotomy competency, as well as IV certification, is preferred.
- 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.
Job Tags
Full time, Work at office