Clinical Research Associate
Há 4 dias
Job OverviewA research coordinator plays a pivotal role in drug/device/outcomes research by independently monitoring studies to ensure patient safety and data integrity.
The position offers a supportive work environment through an extensive co-monitoring approach, with frequent communication both internally and with clients to align on shared goals.
Key Responsibilities:
- Conduct onsite and remote monitoring activities according to ICH-GCP guidelines, regulations, SOPs, and study processes, including site qualification, trial initiation, file maintenance, site personnel instruction, and study close-out.
- Verify the protection of study participants by confirming informed consent procedures and protocol adherence.
- Ensure data integrity and compliance with the protocol, GCP, regulations, 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).
- Write and submit reports of site findings and update tracking systems; escalate issues as needed.
- Manage essential documents per regulations and ICH-GCP guidelines before, during, and after studies; assist with data queries.
- Perform risk assessments, site health analysis, process evaluation, and project escalation.
- Participate in audit preparation and follow-up activities.
Required Skills and Qualifications:
- Undergraduate degree or equivalent in a clinical, science, or health-related field; healthcare professional licensure (e.g., registered nurse).
- Previous clinical trial support experience, including solid on-site monitoring.
- Fluent in English and host country language (reading, writing, speaking).
Benefits:
This role offers a challenging and dynamic work environment, with opportunities for growth and development.
As a research coordinator, you will have the opportunity to work on complex projects, collaborating with cross-functional teams to achieve shared goals.
What We Offer:
We offer a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters collaboration and innovation.
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