Clinical Research Associate Specialist
3 weeks ago
Job Title: Clinical Research Associate Specialist
About the Role:
We are seeking a highly skilled Clinical Research Associate Specialist to join our team at Mirus LLC. In this role, you will be responsible for managing cardiovascular clinical studies, ensuring adherence to critical timelines, and delivering high-caliber document development and quality data collection.
Key Responsibilities:
- Contribute to content generation, writing, and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
- Assist with the management of investigational studies from start through study closure.
- Engage in new study trial design with cross-functional teams, including clinical and pre-clinical research and development groups.
- Contribute to the development of CRFs.
- Assist with the formulation of instructional materials and training of investigators, study coordinators, and associated study site personnel on the conduct of clinical trials, as applicable.
Requirements:
To succeed in this role, you will need:
- A Bachelor's or Master's degree in nursing with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role.
- At least 2 years of experience in clinical research roles, with at least 2 years in CRA roles, preferably in cardiovascular medical device.
- Experience in clinical trials and/or post-market registries in the U.S., Australian, and/or European Union, with other geographies desired.
- Current knowledge of medical device clinical trials design and best practices.
- Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
Benefits:
Mirus LLC offers competitive compensation, options, full benefits, and relocation assistance.
Salary Range: $80,000 - $110,000 per year
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