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

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