We are looking for a Clinical Research Associate to join our growing, global pharmaceutical company. We are putting together a team of 4 CRA's (2 in Texas, 1 in the Northeast, and 1 in Florida) to drive the progress and compliance of our amazing trials. Please read below for more details and apply if you are interested.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
--- Data generated at site are complete, accurate and unbiased
--- Subjects' right, safety and well-being are protected
--- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
--- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
--- Communicates with PIs, Sub PIs and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
--- Identifies, assesses and resolves site performance issues
Reference number: 56794