Clinical Research Coordinator
1 week ago
PRIMARY RESPONSIBILITIES INCLUDE:
· Evaluating prospective patients for eligibility in clinical trials and effectively communicating trial information.
· Facilitating the informed consent process and ensuring patient enrollment in accordance with protocols.
· Overseeing patient care to align with protocol specifications.
· Collaborating with physicians to assess patient conditions, document adverse events, and ensure protocol adherence.
· Ensuring precise and timely data collection, documentation, and reporting, while participating in monitoring and auditing processes.
· Maintaining all necessary regulatory documentation.
· Engaging in mandatory training and educational initiatives, while educating clinic personnel on clinical research practices.
· Potentially supervising the preparation of physician orders to guarantee protocol compliance.
· Communicating study requirements with physicians effectively.
· Upholding a safe environment for patients, families, and clinical staff by adhering to all relevant federal, state, and professional regulations.
· Accurately managing and documenting the receipt and usage of Investigational Products from sponsors.
· Ensuring strict patient confidentiality in accordance with HIPAA regulations and applicable laws.
· Complying with GCP, ICH, HIPAA, NIH, FDA regulations, and SOP guidelines.
· Contributing to the company's growth with potential future supervisory responsibilities.
QUALIFICATIONS:
· Exceptional customer service skills.
· Self-motivated and proactive.
· Outgoing personality with strong recruitment abilities.
· Phlebotomy experience is essential.
· CCRC certification is advantageous.
· Solid background in the medical field.
· Comprehensive understanding of medical research.
· Excellent verbal and written communication capabilities.
· Proficient in computer use, particularly Microsoft Office.
· Familiarity with ICH Guidelines, GCPs, and FDA regulations.
· Ability to manage multiple protocols across various therapeutic areas.
· Detail-oriented with strong organizational skills.
· Willingness to travel as needed.
Educational Background:
· Bachelor’s degree required; Master’s degree preferred.
· Minimum of three years of experience in Clinical Research.
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