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
Salary is based on experience.'
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