Clinical Research Associate Manager
2 semanas atrás
A clinical research associate is responsible for overseeing the conduct of clinical trials to ensure compliance with regulatory requirements and patient safety.
The role involves on-site and remote monitoring activities, including qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study close out.
Clinical research associates verify the protection of study participants by confirming informed consent procedures and protocol adherence according to applicable regulations.
Responsibilities- Conduct on-site and remote monitoring activities as per ICH-GCP guidelines, regulatory requirements, SOPs, and study protocols.
- Ensure the integrity of clinical data and compliance with approved protocols, GCP, regulatory requirements, and SOPs.
- Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data submission.
- Verify proper management and accountability of investigational product (IP).
- Prepare and submit reports of investigational site findings and update tracking systems.
- Escalate observed deficiencies, issues, and corrective and preventative action plans as necessary.
- Manage essential documents before, during, and after clinical studies; assist with resolution of site/data queries.
- Perform key risk assessment and management responsibilities throughout the project.
- Participate in audit preparation and follow-up activities as needed.
- Independently perform various onsite and offsite monitoring visit types.
- Gather and review information for assigned sites and identify inconsistencies.
Requirements include:
- Graduation from an accredited institution with a degree in a clinical, science, or health-related field;
- Health care professional licensure;
- Previous experience supporting clinical trials, including solid on-site monitoring experience;
- Willingness to travel 50-80%;
- Equivalent education, training, and relevant experience may be considered;
- Fluency in English and host country language.
We prioritize building a diverse culture that rewards high performance and nurtures talent.
- Competitive salary and benefits package;
- Annual leave entitlements;
- Health insurance options;
- Retirement planning options;
- Global Employee Assistance Programme;
- Life assurance;
- Flexible country-specific benefits.
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