CRA - MST
This position is responsible for performing both onsite and remote monitoring of clinical sites. The CRA ensures compliance with the ICH GCP, applicable regulatory guidelines and institutional SOPs.
- Assist with site selection activities, including site qualification visits and perform site initiation visits.
- Assist with the development of study-specific, risk-based monitoring plan, study operations manual, tracking forms, and other study related documents as required.
- Ensure the study sites adhere to the protocol, GCP, procedural documents and recommend necessary actions to bring about compliance or improve processes.
- Following Risk Based Monitoring, conduct on-site and remote monitoring to review clinical data for accuracy, completeness and discrepancy resolution.
- Submit monitoring visit reports and monitoring visit follow-up letters within required timelines.
- Anticipate/identify potential problems, implement corrective and preventive actions and escalate where appropriate.
- Assist with supply management and ensure proper storage, dispensation, and accountability of all investigational product(s) and trial-related material at study sites.
- Receive, review and track weekly enrollment updates during site/study enrollment period.
- Liaise with sites and data management or other departments, as requested, to resolve data queries.
- Coordinate with the sites to ensure proper and timely submissions to IRBs, review and assist in preparation of appropriate responses for re-submission if necessary.
- Participate in teleconferences, Investigator Meetings, GCP trainings, Study Close-Out visits and additional visits to sites, as needed.
- Ensure all documents are reviewed and approved prior to submission and implementation at the site.
- Ensure proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) per protocol.
- Ensure safety update reports and other new information are provided to and received by the sites for reporting to ethics, as needed.
- Ensure all Serious Adverse Events (SAE) reports are reviewed, signed off by the responsible physician and filed within required timelines.
- Create and maintain Trial Master Files in compliance with ICH guidelines.
- Contribute to Clinical Development Standard Operating Procedures for conduct of clinical trials based on templates and ensures adherence to regulations/guidelines for GCP.
- Perform site trainings, as needed.
- Perform other duties as assigned by the manager.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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