Job Description

Position Summary

Advanced Bifurcation Systems (ABS) is a coronary medical device developer and manufacturer based in the San Francisco Bay area (Livermore, CA), with a fully developed FDA Class III platform designed to treat all indications of bifurcation disease. With over 75 issued US and international patents, as well as an FDA Breakthrough Device Designation, ABS is poised to become the industry’s standard of care.

Reporting to the Manager/Director of Clinical Operations and the President/COO, the Clinical Research Associate has assigned responsibilities across ABS’ clinical research and trial management arms (both at ABS headquarters and clinical trial sites). Job responsibilities will include, but are not limited to, assisting in the design of clinical studies for an FDA Class III device, coordinating regulatory submissions for clinical investigations, and ensuring appropriate tracking, documentation, and engagement in clinical trials. The Clinical Research Associate will understand clinical workflows and research protocols and will possess a strong ability to communicate effectively with both patients and medical experts. The Clinical Research Associate will collaborate closely with the study PI, participating physicians, participating patients, IRBs, and CROs to implement appropriate clinical protocols and assist in enrolling and monitoring study participants. The candidate should be highly organized, able to analyze complex operational metrics and engage with multiple stakeholders on any given day. The Clinical Research Associate will, in collaboration with the Manager/Director of Clinical Operations, ensure compliance with clinical trial protocols, verify informed patient consent, manage case report forms (CRFs), and submit required regulatory documents.

This position will be structured as a contractual role, anticipating a transition to full-time (W-2) employment (contract to hire) contingent on performance, upon completion of the contract period and in alignment with regulatory timelines. Upon commencement of the W-2 role, in-person attendance at ABS headquarters in Livermore, CA will be required. This position requires travel up to 40%

Qualifications

• Bachelor’s degree in the health sciences or life sciences (e.g., nursing, health administration, public health, biology, bioengineering, etc.). A clinical background is preferred. 
• Experience managing complex projects with the necessary detail and forethought for timely, high-quality execution.
• Experience with various EMR platforms, REDCap, ONCORE, and various EDC systems (Medrio, Medidata, etc.).
• Experience developing study-specific monitoring tools and other related documents.
• Working knowledge of applicable global (domestic and international) regulatory requirements such as U.S. FDA Regulations Relating to Good Clinical Practice and Clinical Trials (21 Title Parts 50, 54, 56), International Conference on Harmonization -- Good Clinical Practice (ICH-GCP), EU MDR, etc. 
• An understanding of medical device development and commercialization.
• Strong interpersonal skills, with excellent verbal and written communication capabilities
• 3+ years of relevant clinical research coordination, clinical operations, or trial management experience.

Responsibilities

• Assists in operational and administrative research support under the clinical direction of the Principal Investigator (PI) and ABS’s Manager/Director of Clinical Operations.
• Screens potential patients for protocol eligibility. Presents trial concepts and details to patients, participating in the informed consent process, and enrolling patients in clinical trials.
• Engages physician investigators in onboarding, reviewing documents, directing appropriate care, and ensuring compliance, training and crafting educational materials (in various mediums) as necessary.
• Responsibly maintains all clinical trial performance and timeline metrics.
• Maintains appropriate study records according to Federal Regulations and ICH Good Clinical Practices.
• Supports internal audit and other compliance-related activities (e.g. preparation for audits, QA verification of clinical data, OEC review of Scientific Research and Publications, tracking of supplies for Sunshine Act reporting)
• Assists in managing ABS’s relationship with clinical sites, clinical vendors, consultants, regulators and strategic partners as relevant to clinical functions.
• Engages in meetings to fully grasp protocols, objectives, timelines, and requirements.
• Ensure the creation and prompt delivery of specific study materials and outputs.
• Regularly reports to ABS management on clinical study related progress, challenges, and achievements, facilitating informed decision-making.
• Continuously monitors the device and assists in conducting post-market clinical follow-up (PMCF) activities to collect and evaluate long-term safety and performance.
• Participates in required training and education programs.
• Other related duties and responsibilities as mutually agreed upon with the ABS management team.

Attributes

• Understanding of clinical research processes and regulatory knowledge.
• Project management capabilities.
• Strong organizational and time management skills.
• Strong interpersonal and communication skills.
• Ability to navigate a rapidly evolving environment, proactively and nimbly shifting responsibilities as necessary.
• A commitment to continuous learning and professional development, with motivation for career growth with commensurate skill cultivation.

Physical Demands

Requirements of this position include the need to frequently stand, walk, sit, and use a computer for extended periods. Specific vision abilities required by this job include close/distant vision and depth perception. This position also requires the use of Personal Protective Equipment (PPE), as needed.

Compensation

Contractual Period: Hourly rate between $55 and $65 per hour, with no hour's cap, but in accordance with company needs.

W-2 Employee: Salary range of $105,000 – $125,000 USD per annum, plus benefits, potential for performance-based bonus, and opportunity for equity participation.

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