As the Senior Clinical Research Associate you will monitor clinical study activities in-house and at clinical study sites ensuring adherence to Good Clinical Practices, SOP’s, international standards and study protocols. You will review and prepare IRB submissions, study training materials as well as prepare site visit reports including site qualification visits, site initiation visits, interim monitoring visits and close-out visits. You must be able to work both independently and as part of a team.
You will participate in study development and start up activities including protocol review, designing and/or reviewing case report forms, preparing informed consent documents, developing study documents and tracking study metrics, and working with management on monitoring strategy.
As the ideal candidate you:
- Have knowledge of GCP and applicable regulations.
- Will provide management with routine updates regarding status of study and clinical study sites.
- Are able to maintain professional expertise through familiarity with clinical literature, education and experience.
- Have a sound knowledge of medical terminology and clinical study monitoring.
- Have excellent interpersonal and organizational skills and attention to detail
- Have proficiency in MS Office.
- Have orthopedic clinical trial experience.
- Have a BS or BA in a science or health care discipline.
- Have 4 – 5 years of on-site monitoring experience.
- Have 3 – 4 years of in-house study activity experience.
- Are able to travel up to 60% as study activities require.