Job Description

Duties a CRC is required to perform include the following core functions, but are not all inclusive of:

• Direct interaction with and caring for human research participants
• Evaluate patients for inclusion and exclusions criteria on multiple protocols
• Schedule and coordinate all subject visits from screening to final follow up
• Perform chart review to evaluate for inclusion/exclusion criteria
• Perform venipuncture using universal precautions
• Perform EKG, vitals and any required trial specific procedures
• Ensure accuracy of data at each visit
• Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs guidelines
• Understand and working knowledge of being “Audit Ready at all times”
• Maintain regulatory documents to ensure most current documents are being utilized
• Support team members and cross-train to maintain knowledge of all delegated trials
• Create and maintain project timelines
• Maintain good relationships with Principal Investigator, site staff, patients and Sponsor/CRO
• Coordinate, record and manage subject data by maintaining accurate and complete source
• Complete case report forms and queries in a timely manner, per SOP guidelines
• Maintain records of receipt, storage and distribution of investigational product
• Attend and facilitate sponsor visits and audits
• Maintain accurate records of subject visits, to complete monthly study invoicing, per CTA
• Complete budget and CTA initial negotiation and amendments as necessary

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