The Sr. CRA provides critical support to the Clinical Affairs Team in the execution and control of clinical trials to ensure trial objectives are met. The Sr. CRA’s primary responsibility is to monitor the progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is being conducted in accordance with the protocol, standard operating procedures, ICH/GCP and other applicable regulatory requirements.
Site Management: serve as primary liaison for assigned study sites; manage all site communications and study-related activities to ensure compliance to protocol, ICH/GCP, and applicable local and regulatory authorities; accountable for data integrity, patient safety and regulatory compliance for assigned sites.
Source Document Verification: conduct a comparison of source documentation against data recorded on electronic Case Report Forms to ensure accuracy and completeness; review and collect regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies and other areas of non-compliance.
Site Compliance: identify areas of non-compliance and ensure issues are addressed, clearly communicated, documented and escalated as required through monitoring visits.
Training: ensure all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and all applicable regulations. Monitor and maintain site personnel list, qualification and training records.
Event Reporting: ensure all reportable events (AEs, SAEs, UADEs) are identified, clearly documented and reported as per protocol and as per applicable local and regulatory requirements.
Collaboration: participate in study-specific monitoring meetings, teleconferences and trainings.
Documentation: produce timely and comprehensive visit, status and follow-up letters.
Other duties as requested
Strong technical/analytical skills to identify and solve problems.
Proven ability to work with high level of integrity, accuracy, and attention to detail.
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
Excellent oral and written communication skills.
Resourceful, creative, enthusiastic and results-oriented.
Enjoys working in a fast-paced, small-company environment.
Must be willing to travel 80%+.
BA/BS degree or equivalent (preferably in a life science, nursing or related discipline)
Minimum 5+ years of direct monitoring and investigative site management experience
Clinical research experience in medical device and oncology trials preferred
Demonstrated computer skills (MS Office and EDC systems)
Working knowledge of FDA regulations and ICH/GCP guidelines
Professional certification (ACRP, SOCRA) desireable
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