You are looking for a Sponsor dedicated CRA position. You have 1-2 years experience as a CRA and now wish to be part of a major pharmaceutical company as a Sponsor dedicated CRA.
The Sponsor dedicated CRA role offers you the opportunity to plan and progress your career in the direction you choose.
Whatever your career goals, we are here to ensure you get there! Read below and apply now!!!
benefits
Some of the advantages you can expect from your role as a Sponsor dedicated CRA are:
- A competitive compensation package is provided
- Consistent workload
- Career development opportunities
responsibilities
The Sponsor dedicated CRA will work independently on site, remote and risk based monitoring of clinical trials. Establish delivery of site qualification visits, start up activities, driving recruitment and ongoing maintenance including delivery of key study milestones, DBLs through to close out of sites
Primary Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and action items to resolution.
- Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
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