Stryker is seeking a Clinical Research Associate (CRA) - Level 1 to drive research initiatives and ensure alignment with strategic goals within the Trauma and Extremities Division, managing clinical studies from selection to closeout.
Requirements
- Fundamental knowledge and good understanding of GCPs, clinical study development process, and logistics
Responsibilities
- Administer protocol and related study training to assigned sites, evaluates the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, study enrollment, data completion and submission, as well as resolution of data discrepancies.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
- Ensure operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards (e.g., ISO, FDA, etc), GCPs, and Stryker Standard Operating Procedures.
- Maintain clinical and regulatory files, as well as clinical inventory intended for distribution to investigational sites.
- Conduct site monitoring (e.g. site selection, site initiation, interim monitoring and closeout visits) and site management activities.
Other
- Work in a virtual team environment, requiring that you be highly engaged, communicate effectively and maintain accurate and timely tracking and documentation.
- Demonstrate strong interpersonal, written and oral communication, organization, time management and planning skills in a fast-paced environment.
- Bachelor’s degree (B.S. or B.A.), preferably within Health Sciences or other related technical discipline
- Minimum 2 years of experience in a clinical research experience as a Clinical Research Coordinator, Clinical Trial Coordinator or Clinical Research Associate
- Certificate Degree in Clinical Research or CCRA (Certified Clinical Research Associate) credentials
- Travel Percentage: 50%
