Clinical Trials Coordinator

POSITION SUMMARY

Under the direction and supervision of the Director of Clinical Trials and Senior Clinical Research Coordinator, this position facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Senior Clinical Research Coordinator in recruiting patients for clinical studies. The position works closely with the Senior Clinical Research Coordinator, members of the department, study sponsors and monitors, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies. 

ESSENTIAL FUNCTIONS

• Maintains communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including:
  • Completes case report forms
  • Maintains study-specific supplies
• Prepares for study closure and archiving

• Administratively and clinically manages an average of 4-5 clinical studies
• Adheres to Research SOP's
• Adheres to Good Clinical Practices and the study protocols
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials
• Discusses study protocols with patients and verify the informed consent documentation
• Provides patient with written communication of their participation (i.e. copy of the signed informed consent)
• Ensures patient's referring physician receives notification of patient's participation in studies as requested by the patient
• Meets with patient for each visit and maintains accessibility to discuss any questions/concerns regarding the study
• Dispenses study medication in a professional and accountable manner following protocol requirements
• Collects, processes, and ships blood/urine specimens at scheduled patient visits
• Performs ECGs and obtains vital signs of patients if required per study
• Schedules all patient research visits and procedures consistent with protocol requirements
• Completes and maintains case report forms per FDA guidelines, and reviews them against the patient's medical record for completeness and accuracy
• Administers questionnaires/diaries per protocol
• Submits regulatory documents to IRB and Sponsor
• Prepares for study initiation
• Obtains physician signatures
• Recruits subjects
• Screens and schedules subjects
• Obtains voluntary subject consent
• Teaches subjects about protocol expectations
• Performs study/protocol procedures in a detailed, accurate manner
• Maintains study files
• Tracks subjects, avoiding lost-to-follow-up
• Documents adverse events
• Processes and ships lab work
• May perform other job related duties as requested or required.

KNOWLEDGE, SKILLS AND EXPERIENCE

Minimum Education (or substitute experience) required:

• High School degree
• CCMA Certificate preferred

Minimum Experience required:

• Three years as a Medical Assistant
• Two years or more in a clinical research setting, preferably working as a clinical research coordinator on Industry-Sponsored clinical trials.
• Phlebotomy experience preferred

Skills required:

• Working knowledge and experience with regulations, GCP guidelines, HIPAA, institutional policies, and SOPs.   
• Excellent knowledge and skill with administrative processes related to clinical research. 
• Experience with monitoring and data collection procedures. 
• Demonstrated experience in use of medical terminology. 
• Excellent skill and knowledge in appropriate use of disease processes, anatomy, and physiology.
• Strong analytical skills to define problems, formulate logical solutions, and make recommendations.
• Excellent organizational skills and experience. 
• Excellent oral and written communication skills.
• Customer Service delivery experience and skill.
• Knowledge and experience with computer systems and programs (Windows or Mac OS, MS Office Suite, web browser applications, e-mail applications, EMR). 

Current Openings for Clinical Trials Coordinator Jobs at Sacramento Ear, Nose & Throat