Medical Monitor (Hybrid Location)
120K–150K a year
Behavioral Health Market Context
Apply Nowvia Ladders
Benefits
Health InsurancePaid Time OffDental Coverage
Job Description
of cardiovascular and structural heart conditions. This is a hybrid role with the ability to travel to headquarters for training and collaboration.
Role:
• 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.
Skills:
• 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.
Requirements:
• 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
Why Join Us:
• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
Role:
• 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.
Skills:
• 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.
Requirements:
• 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
Why Join Us:
• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
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
Benefits
- •We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
- •We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
- •We thrive in our work-hard, play-hard environment
- •Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing
- •We enjoy time inside the office and out!
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
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