Medical Monitor

Benefits

Qualifications

• •Strong interpersonal and communication skills and the ability to work effectively with internal stakeholders and clinical study site personnel
• •Exceptional project management and organizational skills
• •Clear and concise written communication skills
• •Skilled in the use of computers, Microsoft Suite of products
• •Strong work ethic to meet tight timelines and manage multiple projects with a problem-solving, collaborative mindset
• •MD or a licensed RN or equivalent
• •Minimum of 10 years of relevant medical device clinical experience
• •Knowledge of FDA guidelines and other relevant geographical regulations
• •Ability to travel and work onsite in Santa Cruz as needed
• •Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies
• •7 more items(s)

Responsibilities

• •As a Medical Reviewer, you will work with internal cross-functional teams and external clinical partners to provide expert medical review of patient enrollment criteria for potential clinical study candidates and lead clinical study safety oversight
• •The role is fast-paced and evolving, requiring excellent organizational skills and deep understanding of cardiovascular and structural heart conditions
• •This is a hybrid role with the ability to travel to headquarters for training and collaboration
• •Review patient medical history along with screening team to confirm clinical study eligibility
• •Manage clinical safety oversight activities for clinical studies, including Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) coordination
• •Develop safety management plans, committee charters, Standard Operating Procedures, and processes for assigned studies
• •Review adverse events and coordinate activities with data management, regulatory affairs, and clinical affairs to ensure ongoing data quality and safety oversight
• •Develop adverse event narratives for safety committee review
• •Collaborate with investigators, research coordinators, and other clinical study site personnel on safety events
• •Collaborate with regulatory affairs to ensure timely reporting of applicable events
• •Advise on clinical protocol development and safety oversight in accordance with medical society guidelines
• •Create strategy for developing and maintaining clinical education materials, including updates to the materials
• •Review abstracts, manuscripts, and presentations for accurate representation of clinical safety data
• •Collaborates on other clinical affairs activities as needed
• •11 more items(s)