Clinical Research Coordinator 1

Position Overview 

The Clinical Research Coordinator I will perform multiple and varied tasks critical to the management of clinical research studies. The Clinical Research Coordinator I is expected to exhibit basic knowledge of clinical research activities and adhere to federal and other applicable regulations. The Clinical Research Coordinator I must ensure compliance with protocol guidelines, identify problems and/or inconsistencies and monitor subject process throughout the clinical research study.  

To consistently embody AMR’s Core Values: 

• Excellence and Consistency
• Collaborative Innovation
• Respect for our Subjects, Sponsors and Team Members
• Community
• Unimpeachable Ethics

The Clinical Research Coordinator reports to the Site Manager/Team Lead. 

Classification: Non-Exempt 

Primary 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

Desired Skills and Qualifications: 

• 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.
• 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.

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.