Note: The job is a remote job and is open to candidates in USA. Medasource is recruiting for a leading life sciences company seeking a Senior Field Clinical Research Associate focused on cardiovascular Class III medical devices. The role monitors clinical studies across West Coast sites, ensures regulatory and protocol compliance, reviews clinical data and documentation, manages site issues and reporting, supports enrollment, and mentors junior team members.
Responsibilities
- Monitor clinical studies at sites in your assigned territory (and others as requested) to ensure compliance with regulatory requirements, Good Clinical Practice, and study protocols, including site initiation, periodic, and close-out visits
- Ensure both regulatory and clinical protocol compliance is maintained for all assigned clinical projects
- Review data and source documentation from investigational sites for accuracy and completeness
- Ensure timely and accurate reporting of adverse events, protocol deviations, device complaints, and malfunctions according to company policies and procedures
- Resolve and/or facilitate resolution of site issues, including identification of root causes and actions to prevent recurrence
- Coordinate with study teams, field clinical engineers, and specialists to enroll sites into new and ongoing clinical studies
- Facilitate enrollment of study subjects via site coordinators and support resolution of data queries and action items at clinical sites
- Promptly report findings of monitoring visits according to established processes
- Collaborate with in-house teams to ensure complete and timely submission of study documents
- Participate in conference calls and training sessions as required
- Train site personnel to ensure compliance with study protocols and local regulations
- Mentor less experienced clinical team members as requested
- Demonstrate a high level of written and verbal communication skills with internal and external customers
Skills
- Bachelor's degree from an accredited university or college, preferably in natural science, pre-medicine, nursing, bioengineering, or a related field
- Minimum five years of clinical research experience with a superb understanding of all aspects of clinical research
- Strong written, verbal, interpersonal, presentation, analytical, and organizational skills
- Ability to interpret basic clinical data, meet deadlines, and communicate effectively with all levels of employees
- Proficiency with word processing software and relevant clinical applications
- Ability to work independently and within a dynamic, global team environment
- Ability to exchange straightforward information, ask questions, and check for understanding
- Familiarity with cardiac, vascular, and/or neuromodulation technologies
- Prior clinical monitoring experience (strongly preferred)
- Experience in a medical device/pharmaceutical company or clinical/hospital environment (preferred)
- Certification by an industry-recognized professional society (e.g., SoCRA, ACRP) or accredited institution (preferred)
Benefits
- Remote work arrangement with required travel in the West Coast Region
- Part-time, 12-month contract with possibility of extension
- Training sessions as required
- Mentoring and professional development through mentoring less experienced clinical team members
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