Senior Clinical Research Associate
TFS HealthScience•Auburn, ME
•Remote
About The Position
As part of our Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
Requirements
- Degree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical field
- Strong knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirements
- Minimum 5 years experience working as a CRA
- 1 year experience in Ophthalmology
Responsibilities
- Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the applicable monitoring plan
- Oversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issues
- Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
- Review and maintain study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulations
- Collaborate cross-functionally with medical, project management, quality management, and data management teams, and support sites during audits and inspections
Benefits
- competitive compensation package
- comprehensive benefits
- opportunity for personal and professional growth
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
