Clinical Research Associate

Description

• Supervises and coordinates day-to-day activities of clinical sites and serve as the primary Sponsor contact with CROs and vendors related to assigned clinical projects.
• Maintains all relevant site communications and both trial and site master files.
• Participates in investigator site selection.
• Conducts and coordinates activities associated with qualification, initiation, interim monitoring, study close out and audit visits as required.
• Assists in development and review of protocol related documents, case report forms and monitoring plans.
• Assists with the collaborative creation of study protocols, study reports, regulatory reports for discovery, verification, and validation studies, and support for ethical and regulatory submissions as required.
• Communicates with internal departments as needed, including attending required meetings and following-up on action items.
• Assists in development of departmental SOPs and personnel training programs.
• Reviews study data and resolution of queries.
• Travels to study sites based on project needs.

• BA/BS in a life science or other medical discipline.
• 3-5 years of experience (or 5-8+ years for a Sr. CRA) at a Sponsor or CRO.
• Sr. CRA requires experience as a Study Lead and/or Study Manager.
• Medical device or in vitro diagnostic (IVD) experience strongly preferred.
• Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations, GCP, and ICH guidelines is required.
• Excellent planning, problem solving skills, and communication skills with the ability to communicate effectively with all levels of the organization.
• Ability to travel up to 30%
• Proficiency with Office Suite and standard computer programs required.