Clinical Research Coordinator

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Clinical Research Coordinator GEN MED Full Time New Carlisle, OH, US About Company: Tekton Research is a growth-oriented research company focused on excellent conduct of clinical trials. We are team-oriented and core value-centric. We value Focus, Discipline, and Accountability. We offer benefits and a competitive salary. At Tekton Research, we do excellent work and are Making Life Better. Position : Clinical Research Coordinator (Full-Time/Non-Exempt) The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of assigned Phase I–IV clinical trials, including participant, regulatory, and administrative activities. The CRC serves as a key point of contact between sponsors, CROs, investigators, study participants, vendors, and site management while ensuring compliance with sponsor protocols, site SOPs, ICH-GCP guidelines, FDA regulations, and IRB requirements. Reports to: Site Management Job Description: The Clinical Research Coordinator (CRC) manages the daily operations of assigned Phase I–IV clinical trials. It is the responsibility of the CRC to communicate all necessary study-related information to investigators, sponsors, CROs, study participants, and caregivers. The CRC is responsible for identifying and resolving issues that may arise while representing themselves and the site in a professional, ethical, and positive manner. The CRC may also perform unblinded investigational product (IP) management responsibilities, including investigational product accountability, temperature monitoring oversight, and pharmacy-related study coordination while maintaining strict separation of blinded and unblinded study functions when required by protocol. Inform study participants or caregivers about study procedures, risks, benefits, and expected outcomes Screen, recruit, consent, and schedule study participants per protocol requirements Assist with onboarding and training of study team members as assigned Prepare study participant source documents prior to visits and ensure all source documentation is completed contemporaneously during participant visits for optimal accuracy of data collection Complete and enter source documentation and electronic data capture (EDC/eCRF) entries within established study timelines Resolve sponsor-generated EDC queries in accordance with sponsor expectations and site standards Maintain investigator site files (ISF), regulatory binders, study delegation logs, training logs, enrollment logs, informed consent logs, and participant identification logs Maintain required records of study activity including case report forms, investigational product accountability logs, and drug dispensation records Record adverse events (AEs), serious adverse events (SAEs), and side effect data and ensure timely reporting to investigators, sponsors, and IRBs as required Maintain all safety reports for assigned studies and ensure PI review/signoff is completed in a timely manner Attend investigator meetings with Principal Investigators to obtain and discuss pertinent study information Attend site initiation visits (SIVs), monitoring visits, interim visits, audits, inspections, and closeout visits from sponsors and CROs Prepare for and participate in quality assurance audits and inspections Communicate with laboratories, sponsors, monitors, investigators, and vendors regarding laboratory findings, study procedures, and protocol requirements Confer with recruitment/business departments to determine effective recruitment strategies for studies Direct the requisition, collection, labeling, processing, storage, and shipment of laboratory specimens Perform protocol-specific procedures including interviewing participants, obtaining vital signs, performing electrocardiograms (ECGs), and collecting laboratory specimens Support investigational product dosing and participant compliance activities as delegated by the investigator and permitted by protocol Order investigational products, devices, laboratory kits, and study-related supplies necessary for study completion Inventory lab and study supplies and coordinate ordering as needed Other duties as assigned Unblinded (if applicable) / Investigational Product (IP) Responsibilities: Maintain strict separation of blinded and unblinded study responsibilities in accordance with protocol and sponsor requirements Receive, store, track, reconcile, and dispense investigational products in accordance with protocol, sponsor requirements, and pharmacy manuals Maintain accurate drug accountability records, chain-of-custody documentation, temperature logs, and investigational product inventory logs Label and organize investigational product storage areas and ensure all products are secured immediately upon receipt Monitor investigational product storage conditions using validated temperature monitoring systems and ensure compliance with 21 CFR Part 11 requirements and ALCOA+ data integrity principles Ensure proper calibration, maintenance, and documentation of refrigerators, freezers, and temperature monitoring devices Investigate, document, and report temperature excursions, deviations, and corrective/preventive actions (CAPAs) Perform investigational product reconciliation and coordinate product returns or destruction per sponsor guidelines Serve as the primary unblinded contact for sponsors, monitors, pharmacy vendors, and internal study teams when applicable Maintain limited access areas for Investigational Product storage and refrain from sharing any codes or keys to these areas with any other staff Required Skills/Abilities: Experience leading 3-5 studies preferred Ability to work independently and as a member of a team Education and Experience: High school diploma or equivalent required; associate or bachelor’s degree in a health science or related field preferred 2+ years of clinical research experience preferred Physical Requirements: Must be able to work primarily onsite and remotely on occasion if needed Occasional local or overnight travel may be requiredAvailability during business hours is required and occasionally outside of business hours may be required Must be able to lift up to 15 pounds at times #J-18808-Ljbffr ADP, Inc.