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Experienced CRA for Clinical Trials
hace 2 meses
The Senior Clinical Research Associate (Sr CRA) plays a pivotal role in overseeing and coordinating all facets of clinical monitoring and site management in compliance with industry standards and regulations.
Key Responsibilities:- Conduct site evaluations to ensure adherence to protocols and regulatory requirements.
- Maintain ongoing communication with investigative sites to verify compliance and address any issues that arise.
- Document findings and observations in a timely manner, adhering to established business writing standards.
- Participate in investigator meetings and collaborate with client companies to identify suitable investigative sites.
- Manage essential trial documents in accordance with local regulations and ICH GCP throughout the clinical trial lifecycle.
- Provide regular updates on trial status to the Clinical Team Manager (CTM) and ensure study systems are accurately maintained.
- Facilitate effective communication between investigative sites, client companies, and the project team.
- Respond to audits and regulatory inquiries as required.
To excel in this role, candidates should possess:
- A minimum of 4-5 years of experience in onsite monitoring.
- Strong organizational skills and attention to detail.
- Ability to travel frequently as required by project needs.
This position is integral to ensuring the integrity and success of clinical trials, contributing to advancements in medical research.
