Job Title: Coordinator, Clinical Affairs

Supervisor/Manager Title: Director, Clinical Affairs

Job Description Summary: Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects.

Job Responsibilities:

• Participate in site start-up, maintenance, and close-out activities (e.g. tracking site progress, creating regulatory and subject binders, investigate discrepancies, etc.)
• Provides support to CRAs who are conducting site visits, as needed.
• Serves as quality control for study-related documents and is accountable for content accuracy to ensure compliance with GDP, US and OUS regulations, and internal company procedures
• Maintains organization, preparation and ordering of supplies required for clinical studies.
• Provides support to CRAs for preparing documentation, reports, and presentations.
• Coordinates study-related meetings, as needed.
• Minute taker and distributor
• Other incidental duties

Required Education and Experience:

• Requires a Bachelor’s degree in related field

Skills and Abilities Required for This Job:

• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently.
• Good computer skills in usage of MS Office Suite
• Strict attention to detail
• Good written and verbal communication skills
• Must be able to work in a team environment
• Adhere to all company rules and requirements