AMR Clinical · 19 hours ago
Clinical Research Coordinator - RN/LPN
AMR Clinical is seeking a Clinical Research Coordinator I to manage clinical research studies while ensuring compliance with federal regulations and protocol guidelines. The role involves coordinating trials, communicating with sponsors and clinical personnel, and maintaining documentation throughout the research process.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Coordinate clinical trials per FDA requirements and GCP guidelines per sponsor protocols
Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study
Basic understanding of medications per clinical trial
Acquire detailed knowledge of the protocol and procedures associated with each clinical research study
Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry
Advise Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study
Notify Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol
Maintain familiarity with each clinical research study’s requirements and apply all applicable regulations accurately
Complete all required documentation in a legible and timely fashion
Ensure all necessary documents are appropriately signed and dated
Travel to Investigator Meeting as needed
Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed
Other duties as assigned
Qualification
Required
Valid RN or LPN license
Successful completion of a formal medical/clinical educational program or in the alternative has a strong knowledge of medical terminology and the ability to learn quickly
Coordinate clinical trials per FDA requirements and GCP guidelines per sponsor protocols
Basic understanding of SOPs and ensure they are adhered to in the conduct of the clinical research study
Basic understanding of medications per clinical trial
Acquire detailed knowledge of the protocol and procedures associated with each clinical research study
Effectively communicate with clinical research sponsors, CROs, monitors/CRAs, IRBS, laboratories and clinical personnel within the research industry
Advise Investigator, Sub-Investigator and staff on protocols, procedures required for the successful implementation and completion of each clinical research study
Notify Investigator, monitor/CRA of any adverse events or serious adverse events per the protocol
Maintain familiarity with each clinical research study's requirements and apply all applicable regulations accurately
Complete all required documentation in a legible and timely fashion
Ensure all necessary documents are appropriately signed and dated
Travel to Investigator Meeting as needed
Possess a willingness to assume responsibility for tasks outside of your current role and to work flexible hours as needed
Other duties as assigned
Preferred
Clinical experience involving patient care in a healthcare environment preferred but not required
Ability to interpret and perform clinical, laboratory and diagnostic tests (such as vital signs, height, weight, temperature, etc.) preferred
Ability to function independently with minimal supervision, and to exercise discretion and a high level of good clinical and other professional judgement
Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing conditions and deadlines)
Exceptional written and verbal communication skills
Ability to work independently, lead clinical research studies and complete tasks
Calm, friendly, approachable, and presents a professional image
Excellent listening, written, and verbal communication skills
Committed, highly energetic, self-motivated and highly organized
Demonstrated proficiency in office equipment including (but not limited to) copy machines, facsimile machine, multi-line telephones and computers
Proficient in Microsoft Office products including Outlook, Word, and Excel
Professional and highly motivated 'self-starter' with the ability to exercise initiative
Excellent task management and prioritization skills