Job Description

  Position Summary 

Reporting to the President & COO, the Clinical Affairs Lead Coordinator / Manager has assigned management responsibilities for all of ABS’ clinical operations including clinical research. The incumbent’s job responsibilities include (but not limited to) developing clinical strategies, creating clinical evaluations, carrying out clinical research, orchestrating clinical investigations, and monitoring devices in the market. Operating as the interface between science and regulations, the clinical affairs lead coordinator/manager plays an essential role in demonstrating the safety and performance of a medical device. He/she/they will organize and oversee all aspects of the clinical research program, collaborate with the physicians and staff to identify and implement clinical protocols appropriate to the patient population, assist the physician in enrolling and monitoring patients placed on clinical trials, ensure compliance with the clinical trial protocols, verify informed patient consent, manage case report forms (CRFs), complete and submit all regulatory documents, and communicate with IRB to ensure the protection of rights, safety and well-being of human study subjects. The incumbent will also have the responsibility of ensuring that scientific integrity of the data collected is protected and verified. 

Qualifications 

• Bachelor’s or Master’s degree in medicine, biology, pharmacy, chemistry, or equivalent. A doctorate degree which signals further specialization and depth in the relevant area is an added advantage.
• Proven functional leadership experience in participating in and/or leading clinical programs focused on the development and commercialization of medical devices, ideally in the cardiology field.
• Strong working knowledge of applicable global (domestic and international) regulatory requirements such as U.S. FDA Regulations Relating to Good Clinical Practice and ClinicalTrials (21 Title Parts 50, 54, 56), International Conference on Harmonization-- Good ClinicalPractice (ICH-GCP), EU MDR, etc.
• Proven experience in understanding the complexity of medical device development, clinical investigations, and regulatory requirements.
• 5-10 years of relevant industry experience.

Responsibilities 

• Lead, as directed, ABS’ clinical research functions.
• Submit all documentation to IRB to open, renew, close and update clinical protocols according toIRB policies and applicable standards.
• Maintain appropriate study records according to Federal Regulations and ICH Good ClinicalPractices.
• Identify/create detailed clinical evaluation protocols and reports.
• Formulate the clinical study’s objectives, such as the clinical endpoints, plan the study, and monitorClinical Research Organizations (CROs) as required.
• Prior to enrollment of patients review documents with involved physicians and staff to direct care and ensure compliance with all aspects of each protocol.
• Lead or assist in managing ABS’s relationship with clinical sites, clinical vendors, consultants, regulators and strategic partners as relevant to the Clinical functions.
• Engage in study meetings to fully grasp protocols, objectives, timelines, and requirements.
• Ensure the creation and prompt delivery of specific study materials and outputs.
• Regularly report to management on clinical study related progress, challenges, and achievements and facilitating informed decision-making.
• Continuously monitor the device and conduct Post-Market Clinical Follow-up (PMCF) activities to collect and evaluate long-term safety and performance information.
• Other duties and responsibilities as mutually agreed.

Attributes 

• In-depth understanding of clinical research processes, regulatory knowledge, and project management capabilities.
• Ability to grasp the extensive global (domestic and international) regulatory requirements and know how to meet them to get devices approved in cost-effective ways.
• Good negotiation skills and assertiveness to effectively serve as intermediaries between different stakeholders (such as regulatory authorities, clinical research partners, and internal customers),
• Strong organizational skills, setting priorities and actively driving clinical projects with many stakeholders.
• Strong analytical and critical thinking skills, with the ability to make sound decisions based on data, information, and emotional intelligence.
• Keen interest in emerging technologies and trends and their evaluation.
• Ability to navigate a rapidly changing and evolving environment.
• Ability to influence management and staff including mentoring others.
• A commitment to continuous learning and professional development.
• Firm grasp of medical terminology and HIPAA regulations.

Physical Demands 

The position is a full-time position requiring an on-site presence Monday through Friday (or as demanded by business needs). The position may also require travel (up to 40%). Other requirements of the 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. Position also requires use of Personal Protective Equipment, as needed.

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