Manages clinical research study tasks with a specialized focus on investigational product handling, administration, and subject safety. Coordinates trial activities in compliance with FDA regulations, GCP guidelines, and protocol-specific requirements.
Requirements summary
Requires an active, unrestricted clinical license such as an RN or LPN and at least one year of clinical or research experience. Must possess strong organizational skills and the ability to perform clinical procedures like phlebotomy and vital signs collection.
professional certificateRegulatory CompliancePhlebotomyMedical TerminologyPatient EducationMicrosoft OfficeSpecimen ProcessingClinical Research CoordinationFDA RegulationsGCP GuidelinesPatient RapportClinical Data CollectionInvestigational Product ManagementDose CalculationSAE ReportingALCOA+ PrinciplesIRT/IVRS/EDC Systems
Job description
Position Overview
The Licensed Clinical Research Coordinator I (Licensed CRC I) performs and manages tasks that are critical to clinical research studies while maintaining a specialized focus on Investigational Product (IP) management, accountability, and subject safety. This is a dual-role position responsible for full Clinical Research Coordinator responsibilities in addition to licensed duties related to IP handling, preparation, and administration in accordance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and protocol-specific guidelines.
The Licensed CRC I performs all responsibilities in accordance with the Delegation of Authority (DOA) log and within the scope of their professional licensure.
To consistently embody AMR Clinical’s Core Values
United We Achieve
Celebrate Diverse Perspectives
Do the Right Thing
Adapt and Persevere
The Licensed Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities
Ensure compliance with protocol deviations, SAE reporting, and informed consent
Coordinate clinical trials per FDA regulations and GCP guidelines
Manage and document Adverse Events (AE) and Serious Adverse Events (SAE) in accordance with FDA, IRB, and sponsor requirements
Develop understanding and ensure adherence to SOPs and study protocols
Develop and maintain detailed knowledge of protocol-specific requirements, including investigational product (IP) handling, dosing, preparation, and administration
Communicate effectively with sponsors, CROs, IRBs, monitors/CRAs, laboratories, and clinical team members
Establish and maintain patient rapport
Perform clinical data collection (vital signs, EKGs, height, weight, etc.)
Obtain and review medical records as required
Perform phlebotomy and specimen collection, processing, and storage
Transport clinical specimens per protocol requirements
Educate subjects and ensure compliance with study requirements, including diaries and visit expectations
Complete subject follow-up and phone visits within protocol-defined timelines
Ensure documentation follows ALCOA+ principles and is completed in real time or within required timelines
Ensure all required documents are accurate, complete, signed, and dated
Maintain study documentation and regulatory compliance
Manage study supplies and order inventory as needed
Prepare for and support monitoring visits, audits, and inspections
Maintain familiarity with all ongoing clinical research studies at the site
Promote team collaboration and support site operations as needed
Perform all duties in accordance with the Delegation of Authority (DOA) log and protocol requirements
Investigational Product (IP) Responsibilities
Receive, verify, and document investigational product (IP) shipments, ensuring accuracy against sponsor documentation
Maintain complete chain of custody for IP from receipt through final disposition
Ensure proper storage of IP per protocol requirements
Maintain accurate, complete, and audit-ready IP accountability logs at all times
Ensure accurate and complete source documentation for all IP-related activities, including preparation, dispensing, administration, and return
Utilize IRT/IVRS/EDC systems for randomization, IP assignment, and inventory tracking as required
Monitor temperature logs and temperature monitoring devices (e.g., TempTales) in accordance with protocol and site SOPs
Identify, document, and report temperature excursions; quarantine affected IP and notify sponsor/CRO per protocol requirements
Manage IP inventory and proactively request resupply to prevent shortages or overages
Monitor expiration dates and ensure expired or unusable IP is promptly quarantined and documented
Prepare IP doses or containers for subject visits in accordance with protocol and within scope of licensure
Assist the PI/Sub-I with dose calculations, titrations, and administration of IP as appropriate
Administer investigational product as permitted by licensure, protocol, and state regulations
Educate subjects on dosing regimen, storage (if applicable), and compliance expectations
Perform IP compliance review, including reconciliation of returned IP (e.g., Syringe/pill counts, device checks)
Maintain blinding integrity and adhere to protocol-specific blinding requirements, including separation of blinded and unblinded responsibilities as applicable
Ensure IP readiness to support efficient subject visit flow and prevent delays in dosing
Ensure ancillary supplies required for IP preparation and administration are available
Coordinate return or destruction of IP per sponsor/CRO instructions
Support and participate in IP reconciliation during monitoring visits and closeout visits
Ensure IP preparation areas and equipment (e.g., biosafety cabinets, if applicable) are maintained and cleaned per protocol and site SOPs
Monitor subjects for safety concerns related to investigational product and escalate appropriately
Assist in training site staff on IP handling, storage, and documentation procedures as directed
Ability to multitask in a fast-paced, evolving environment
Demonstrated Skills
Strong medical terminology knowledge
Willingness and ability to perform clinical procedures (vital signs, phlebotomy, specimen handling, etc.)
High attention to detail, particularly in regulated processes such as IP accountability
Experience with Microsoft Office and clinical systems
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex, national origin, disability, age, or other protected status.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
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This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
