Job description
Position: Clinical Research Associate
Summary: Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Oversees clinical site activities. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete, and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.
Responsibilities:
· Performs pre-study, initiation, interim monitoring, and close-out visits according to applicable SOPs, GCP, and FDA Guidelines.
· Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data.
· Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations, and data integrity.
· Provides technical, scientific, and operational guidance to study site personnel on the protocol.
· Assists with the tracking and reporting of enrollment and works with the site to identify enrollment issues, barriers, and strategies.
· Implements project-specific processes and tools.
· Responsible for maintaining or gathering site/project-specific information as directed by the sponsor and project management.
· Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation.
· Assists other team members with site-specific issues, acting as a liaison between study staff and project staff.
· Must be able and willing to travel as the project requires.
· Performs other tasks as directed by line management or project leadership.
Minimum Requirements:
§ This position requires a B.S./B.A. in a health-related or scientific field and a minimum of 2 years of experience in clinical research, or an equivalent combination of education and experience.
§ Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
§ Experience in ophthalmology preferred.
§ Some experience in field monitoring is preferred.
§ Ability to travel 60% to 70% of the time.
Skills & Attributes:
· Highly customer service oriented.
· Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally.
· Competent communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.
· Demonstrates analytical and problem-solving skills and appropriate judgment regarding issue identification and escalation.
· Strong attention to detail,
· Competent computer and organizational skills.
· Works well independently and as part of a dynamic project team.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Application Question(s):
- What industries have you worked in?
- Did you conduct monitoring visits (PSVs, SIVs, IMVs, COVs), onsite or remote?
- How many visits would you be able to conduct monthly?
Experience:
- Ophthalmology industry: 1 year (Preferred)
Work Location: Remote
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