What are the responsibilities and job description for the Clinical Research Coordinator (Knoxville, TN) position at CEDENT?
Position Overview
The Registered Nurse/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.
Shift Details: Tuesday, Wednesday, Thursday from 6:30pm-7:00am
To consistently embody Client’s Core Values:
Classification: Non-Exempt
Primary Responsibilities:
The Registered Nurse/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.
Shift Details: Tuesday, Wednesday, Thursday from 6:30pm-7:00am
To consistently embody Client’s Core Values:
- Excellence and Consistency
- Collaborative Innovation
- Respect for our Subjects, Sponsors and Team Members
- Community
- Unimpeachable Ethics
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
- Valid RN 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.
- 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.
