The Senior Clinical Research Specialist (Sr. CRS) will conduct clinical research throughout all stages of a project, including design, implementation, and execution. This role will be responsible for one or multiple global clinical studies at all phases (feasibility, pivotal, post market). The Sr CRS will be responsible for collecting, analyzing, and reporting accurate trial data to support expanded market access. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Prepare and author clinical documents such as: protocols, patient informed consents, case report forms, clinical trial agreements, and/or investigator brochures/report of prior investigations as needed
- Develop and execute site training on protocol and data management requirements
- Develop monitoring plans and monitor or oversee monitoring of clinical sites
- Oversee adverse event review committees and/or data review committees as necessary
- Identify and communicate with CROs as necessary based on study needs
- Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
- Prepare and maintain clinical trial budgets for specific project
- Author clinical reports (interim and final) for both regulatory bodies and publications as necessary
- Communicate cross functionally with multiple stakeholders in the company – including regulatory, marketing, product development, etc.
- Develop and deliver presentations for upper management as necessary regarding project status and data results.
- BA/BS education required.
- 5 years minimum experience – preferred in the medical device industry.
- Experience with Microsoft Office: Word, Excel, PowerPoint.
- Highly skilled and proficient at clinical trial management/execution – garnered from education and/or experience on the job
- Conduct complex work under minimal supervision and with wide latitude for independent judgment.
- Light work, exerting up to 20 lbs. of force or less.
- 85% of time requires viewing and working at computer screen.
- Significant work pace & pressure due to deadlines.
- Travel 25%
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Director of Clinical Affairs|