Baptist Health
MCI Protocol Activation Coordinator 2, FT, 8A-4:30P
Baptist Health, Miami, Florida, us, 33222
Baptist Health South Florida is the region’s largest not-for-profit healthcare organization with 12 hospitals, more than 27,000 employees, 4,000 physicians, and 200 outpatient centers, urgent care facilities, and physician practices spanning across Miami-Dade, Monroe, Broward, and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. Baptist Health is supported by philanthropy and committed to its faith-based charitable mission of medical excellence.
Our mission, vision, and values make us who we are at Baptist Health and are at the center of everything we do. At Baptist Health, we positively impact the human experience for patients, employees, and physicians. Our success comes from a culture of quality and dedication that is instilled into every member of the Baptist Health family.
This year, and for 24 years, we’ve been named one of Fortune’s 100 Best Companies to Work For, based on employee feedback. We’ve also been recognized as one of America’s Most Innovative Companies and People Magazine included us in 50 Companies That Care. Based on the U.S. News & World Report 2023-2024 Best Hospital Rankings, Baptist Health is the most awarded healthcare system in South Florida, with its hospitals and institutes earning 45 high-performing honors.
But really, the reason we’re excited to come to work is the people.
Working together, we form personal connections with our colleagues that are stronger than most of us have experienced at other jobs. We develop caring relationships with our patients and their families that go beyond just delivering healthcare. After all, we know what it’s like to be in their shoes. Many of us have been patients here and have had family members as patients here. We’re committed to delivering quality care in the most compassionate way possible because we feel a personal stake in the outcomes. When it comes to caring for people, we’re all in.
Description:This role will be a part of the Protocol Activation Core in the Office of Clinical Research (OCR) at Miami Cancer Institute (MCI). This core is responsible for ensuring that the MCI portfolio of research successfully progresses through the Institutional and Departmental requirements necessary for full approval and activation while achieving all procedural timelines and metrics. This role will operate under the Protocol Activation Supervisor and will serve as project manager for an assigned study portfolio, providing a high level of technical and regulatory expertise and guidance to research faculty and staff and tumor site teams in accordance with the current Food and Drug Administration (FDA) regulations/guidance and MCI/BHSF policy. Must be attentive to detail and able to work collaboratively in a high-volume, multi-tasked environment to achieve goals. Able to provide regulatory guidance to research staff and serve as a mentor to fellow members of the protocol activation team.
Estimated salary range for this position is $59359.09 - $77166.82 / year depending on experience.
Qualifications:Degrees: Associates Degree
Licenses & Certifications: ACRP Certified Clinical Research Coordinator, SOCRA Certified Clinical Research Professional, CCB Certified in Healthcare Research Compliance, Certified Research Contract Professional
Additional Qualifications: A minimum of 2 years experience in a clinical trial regulatory role or Bachelor‘s degree in lieu of 2 years research experience. Research certification (CCRP, CCRC, CRCP or CHRC) required, new employees in this role without certification will have 2 years to obtain research certification. Able to interpret complex research protocols quickly and discern the explicit and implicit terms needed for activation. Strong working knowledge of Code of Federal Regulations applicable to research (e.g. 21 CFR Part 11, 50, 54, 56, 312, 314, 812, 814, 45 CFR Part 46, ICH Guidelines). Must be able to work with and navigate various IT systems used for tracking research studies.
Minimum Required Experience:
EOE
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Our mission, vision, and values make us who we are at Baptist Health and are at the center of everything we do. At Baptist Health, we positively impact the human experience for patients, employees, and physicians. Our success comes from a culture of quality and dedication that is instilled into every member of the Baptist Health family.
This year, and for 24 years, we’ve been named one of Fortune’s 100 Best Companies to Work For, based on employee feedback. We’ve also been recognized as one of America’s Most Innovative Companies and People Magazine included us in 50 Companies That Care. Based on the U.S. News & World Report 2023-2024 Best Hospital Rankings, Baptist Health is the most awarded healthcare system in South Florida, with its hospitals and institutes earning 45 high-performing honors.
But really, the reason we’re excited to come to work is the people.
Working together, we form personal connections with our colleagues that are stronger than most of us have experienced at other jobs. We develop caring relationships with our patients and their families that go beyond just delivering healthcare. After all, we know what it’s like to be in their shoes. Many of us have been patients here and have had family members as patients here. We’re committed to delivering quality care in the most compassionate way possible because we feel a personal stake in the outcomes. When it comes to caring for people, we’re all in.
Description:This role will be a part of the Protocol Activation Core in the Office of Clinical Research (OCR) at Miami Cancer Institute (MCI). This core is responsible for ensuring that the MCI portfolio of research successfully progresses through the Institutional and Departmental requirements necessary for full approval and activation while achieving all procedural timelines and metrics. This role will operate under the Protocol Activation Supervisor and will serve as project manager for an assigned study portfolio, providing a high level of technical and regulatory expertise and guidance to research faculty and staff and tumor site teams in accordance with the current Food and Drug Administration (FDA) regulations/guidance and MCI/BHSF policy. Must be attentive to detail and able to work collaboratively in a high-volume, multi-tasked environment to achieve goals. Able to provide regulatory guidance to research staff and serve as a mentor to fellow members of the protocol activation team.
Estimated salary range for this position is $59359.09 - $77166.82 / year depending on experience.
Qualifications:Degrees: Associates Degree
Licenses & Certifications: ACRP Certified Clinical Research Coordinator, SOCRA Certified Clinical Research Professional, CCB Certified in Healthcare Research Compliance, Certified Research Contract Professional
Additional Qualifications: A minimum of 2 years experience in a clinical trial regulatory role or Bachelor‘s degree in lieu of 2 years research experience. Research certification (CCRP, CCRC, CRCP or CHRC) required, new employees in this role without certification will have 2 years to obtain research certification. Able to interpret complex research protocols quickly and discern the explicit and implicit terms needed for activation. Strong working knowledge of Code of Federal Regulations applicable to research (e.g. 21 CFR Part 11, 50, 54, 56, 312, 314, 812, 814, 45 CFR Part 46, ICH Guidelines). Must be able to work with and navigate various IT systems used for tracking research studies.
Minimum Required Experience:
EOE
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