Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

SUMMARY OF THE JOB:

The Clinical Field Specialist role will support clinical research activities in the field as it relates to the execution of clinical trials to support approval and commercialization of medical devices. The role will be responsible for supporting the planning, conducting, and execution of clinical trials within the US and globally of varying size and complexity.

Responsibilities:

• Responsible for supporting clinical trial research in the field related to clinical trial operations including the following:Procedural/case support, SQV, SIV, EDC query resolution, facilitation of core-lab image uploading, and serving as a resource to site PI and clinical research staff
• Contribute to the design, implementation and conduct of innovative clinical trials
• Ability to maintain strict device accountability to account for device movement and utilization
• Identifying and developing strongcollaborative relationships with study investigators, clinical sites and external service providers
• Maintaining accountabilities for all relevanttimelines and deliverables related to the field operations team
• Develop trainingcurriculum for clinical fieldteam members and physicians
• Achievement of site and trial enrollment goals
• Responsible for procedural training of teammates and to establish and develop procedural best practices toguide the safe and efficacious use of the Bolt IVL System
• Assisting with the creation and implementation of SOPs for Field ClinicalOperations
• Collaborating with cross-functional teamsin the design and execution of clinical trials, including adherence to GCP, ICH, and FDA guidelines.
• Supporting study execution.
• Support audits and inspections, as needed.

Qualification:

Education:

• Bachelor's degree, preferably in life sciences or similar field (advanced degree preferred e.g., Masters, PhD, etc.) and/or extensive cath lab work experience.

Required Experience:

• 10+ years of clinical experience with complex medical devices
• >5 years of experience supporting clinical trials in the field
• Extensive experience with field based clinical trial work
• Expertise in interpreting coronary and peripheral angiography
• Demonstrated ability to travel extensively within the USA and Internationally.

Knowledge, Skills, and Abilities:

• Experience with physician engagement
• Experience in clinical site management
• Experience supporting complex procedures requiring pre-case planning, procedural guidance in a protocol defined manner
• Experience in supporting 501K and IDE clinical trials
• Experience working in a dynamic startup environment

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