Clinical Research Coordinator

Job Description

Job Description

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 required
• Availability 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