Licensed Clinical Research Coordinator I

Licensed Clinical Research Coordinator I

The Licensed Clinical Research Coordinator 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

Desired Skills and Qualifications:

Required Qualifications:

• Active, unrestricted clinical license (e.g., RN, LPN)
• Minimum 1 year of clinical or research experience
• Strong organizational and communication skills
• 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.

** 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.