Clinical Research Associate II
2 months ago
We are seeking a highly skilled Clinical Research Associate II to join our team at ICON Strategic Solutions. As a key member of our clinical operations team, you will be responsible for ensuring the smooth conduct of clinical studies at sites.
Key Responsibilities- Evaluate, initiate, monitor, and close out clinical study sites to ensure compliance with protocols, Good Clinical Practice regulations, and regulatory requirements.
- Document all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines.
- Train and re-train site personnel on protocols, systems, and operational aspects of trials.
- Serve as primary contact for site personnel and liaison between site personnel and sponsor study team members.
- Develop patient recruitment strategies in conjunction with clinical sites to meet enrollment timelines.
- Ensure subjects' rights, safety, and well-being are protected.
- Ensure compliance with procedures for adverse events and serious adverse events.
- Evaluate the quality and integrity of reported data and ensure timely resolution of queries.
- Assist with data validation and cleaning procedures to ensure timely completion.
- Identify, assess, and resolve site performance, quality, or compliance problems and develop intervention plans.
- Communicate with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment, and overall site performance.
- Maintain audit-ready clinical trial documentation and collect, review, monitor, and file required regulatory documentation.
To be successful in this role, you will need:
- Strong understanding of clinical trials and Good Clinical Practice regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Ability to travel to clinical sites as required.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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Clinical Research Associate II
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