Clinical Affairs Specialist

MediView is building the future of surgical guidance and navigation with augmented reality and artificial intelligence. Our team is seeking a driven, skilled, and highly motivated individual for the role of Clinical Affairs Specialist. This position will be responsible for supporting projects related to clinical testing—including, pre-clinical testing, clinical trials, and monitoring sites for compliance. This individual will participate in clinical research, technical writing, regulatory discussions with the team regarding strategy, and will support the team in other related capacities. This individual will work closely with the Regulatory, Marketing, Commercial, and R&D teams at MediView, as well as with MediView user researchers and technical program managers to apply key learnings to further product development.

Essential Duties and Responsibilities:

Clinical Trial Monitoring:

• Assist with clinical trial activities at investigational sites (will require travel to investigational sites).
• Provide training and support clinicians pre-procedurally, intraprocedurally, and during research activities on-site as needed.
• Provide intra-procedural support during early-phase clinical research activities.
• Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
• Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
• Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV).
• Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
• Monitor site’s completion of action items between visits.

Study-Specific Documents and Files:

• Participate in internal TMF reviews, as needed.
• Review and draft informed consent forms and study logs
• Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development.

Regulatory Affairs:

• Assist with submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions.
• Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision.
• Assist with the development and completion of Clinical Evaluation Plans and reports for company products (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators.

Communication and Meetings:

• Participate in project meetings and investigator meetings and write minutes.
• Additional Responsibilities:
• Assist with submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow up until approval is obtained.
• Prepare annual trial progress reports for IRBs/ECs and CAs/FDA.
• Report Serious Adverse Events to Sponsor, IRBs/ECs, CAs/FDA and investigators.
• Prepare clinical trial agreements and discuss/negotiate between site and Sponsor.
• Relevant work experience in clinical research as a clinical research associate (CRA) is preferred.
• Previous experience with medical device or medical technology studies preferred
• Ability to understand basic and complex medical details
• Knowledge of regulatory regulations and guidelines on medical devices
• Ability to travel

Supervisor Responsibilities

This position will report to the Clinical Affairs Manager at MediView XR and will define attainable goals for each quarter. This position would meet with their supervisor and the rest of the clinical and regulatory team on a regular basis, while also providing autonomy and authorship of key deliverables.

Competencies:

• Interpersonal communication.
• Data analytics and basic statistics.
• Use of technology (computer, augmented reality headsets, ultrasound equipment).
• Technical writing skills (applicant may be asked to provide examples of past publications or projects to demonstrate this competency).

Qualifications:

• Bachelor of Science in a technical field (engineering, math, science, nursing, etc.) is required.
• 3-5 yrs of experience in clinical research/trials or related field is preferred.
• Experience in interventional radiology, radiology technology, sonography, or related systems is preferred, but not required.
• Ability to lift up to 30 lbs. and may be responsible for moving/packing equipment.
• Must be willing to travel approximately 60% of the time with overnight stays.