Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate at Parexel working on clinical trials and study protocol adherence. Building relationships with sites and ensuring compliance with regulations and standards.
Responsibilities:
- Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol
- Build relationships with investigators and site staff
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
- Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis
- Conduct on-site visits for Qualification and Initiation visits
- Generate visit/contact report
- Evaluate overall compliance and performance of sites and site staff
- Ensure that assigned sites are audit and inspection ready
- Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships
Requirements:
- Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
- Sound problem solving skills.
- Able to take initiative and work independently
- Advance presentation skills.
- Client focused approach to work.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Developing ability to work across cultures.
- Holds a driver’s license where required.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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