This is an exciting opportunity for an energetic and organized CRA with at least 2 years monitoring experience to grow their clinical career to a CRA II. In this position you will assist and provide support to the members of the clinical trial team in order to facilitate the clinical trial processes including execution of clinical trials. The CRA II will assist with the following: designing, implementing and maintaining clinical trials; writing protocols, case report forms and consent forms; and recruiting and selecting investigators and ensuring good clinical practices are followed.
Duties and Responsibilities include the following
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Assist in designing, planning, and implementing a variety of clinical research projects
- Assist in the design of study protocol, case report forms, informed consent to allow for accurate and thorough data collection to support the product through the approval process
- Review study records including case report forms, consent forms, and other materials
- Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements
- Organize data in systematic manner to allow for efficient and accurate clinical reports.
- Perform site visits to ensure regulatory and study requirements are being fulfilled
- Provide on-site support in the operating room or clinic during clinical study procedures
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
- Bachelor’s Degree in a Health or Science field preferred
- Minimum of 2 years of related experience to include monitoring
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
- Excellent organizational skills and attention to detail
- Ability to travel approximately 35-40% for site training, clinical study procedure support, monitoring responsibilities and educational seminars