169 regulatory coordinator jobs found

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Thoracic clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. This position is...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. This position is remote...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. Remote work my only be...

The Pediatric Solid Tumor Program at Dana-Farber Cancer Institute is seeking to hire a motivated Regulatory Coordinator (RC) to work within the Clinical Translational Research Program (CTIP) on trials specific to the Solid Tumor Clinical Trials portfolio. The pediatric Solid Tumor Program is one of the largest in the world and treats children with a range of solid tumor diagnoses providing novel and cutting edge therapies for these rare diseases. The Regulatory Coordinator (RC) will work under the direction of the clinical trial Principal Investigator(s), the CTIP Associate Director, and CTIP Clinical Research Manager to complete the regulatory requirements relevant to each clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work...

The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s) and Clinical Research Manager to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Offices at the various DF/HCC institutions. Regulatory Compliance: Prepares and submits all protocol...

Description Location: UCHealth Parkview Medical Center, US:CO:Pueblo Department: Medical Staff Services FTE: Full Time, 1.0, 80.00 hours per pay period (2 weeks) Shift: Days Pay: $38.91 - $60.31 / hour. Pay is dependent on applicant's relevant experience Summary: Develops and oversees activities designed to promote regulatory compliance and continual survey readiness. Responsibilities: Stays informed of regulatory/standards changes and interprets applicability of changes across patient care, ancillary, and general departments. Develops, implements, and maintains processes to manage the reporting, investigation, and resolution of regulatory issues. Guides action plan development, performance monitoring and reporting when deficiencies are identified to reduce the risk of noncompliance. Works collaboratively to identify best practices, ensure survey readiness, and prepare/deliver compliance communications and training throughout the organization. Within...

Responsible for submitting protocols to the Insitutional Review Boards for research and maintaining accurate protocol files.

Reporting to an Associate Director within the Clinical and Translational Investigative Program (CTIP) and the specific disease center, the Regulatory Operations Manager (ROM) is responsible for supporting disease groups research portfolio; managing the development and quality control of protocol documents prior to IRIS and/or CHeRP submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS and CHeRP submission, review and approval timelines / institutional benchmarks are met. This position is the primary point person responsible for the collaboration / navigation with the Dana-Farber Cancer Institute (DFCI) and Boston Children’s Hospital (BCH) IRB contacts, clinical trial sponsors, the designated Principal Investigator and the disease group Clinical Research Manager to facilitate and streamline each process within established timelines. The ROM is responsible for closely managing regulatory submissions and communication following a...

The Senior Regulatory Operations Manager (Senior ROM) reports directly to the CTO Associate Director – Regulatory Operations, the CTO Sr. Director and assigned disease group research leadership. This position is responsible for overseeing the specific assigned disease group’s research portfolio and, when applicable, to share regulatory oversight within the assigned regulatory POD. Will be responsible for managing the development and quality control of protocol documents preparation prior to IRIS submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS submission, review and approval timelines / institutional benchmarks are met. This position is the primary point person responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator(s) and the disease group Clinical Research Manager(s) to facilitate and streamline each process within established timelines. The...

Overview The LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe organized manner. Responsibilities include but are not limited to administration of medications, documentation of medication administration, conducting SHUs, and providing resident care while demonstrating the Mission for Sunrise Senior Living, “to champion the quality of life for all seniors” in accordance with federal, state/provincial, and local laws, standards and regulations and Sunrise Senior Living policies to promote the highest degree of quality care and services to our residents. Responsibilities Responsibilities: As a part of the Sunrise team, supporting our Mission, Principles of Service and Core Values is a fundamental part of this job. Our foundational belief is the sacred value of human life. The unique responsibilities for this role include but are not limited to the essential...

Overview The LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe organized manner. Responsibilities include but are not limited to administration of medications, documentation of medication administration, conducting SHUs, and providing resident care while demonstrating the Mission for Sunrise Senior Living, “to champion the quality of life for all seniors” in accordance with federal, state/provincial, and local laws, standards and regulations and Sunrise Senior Living policies to promote the highest degree of quality care and services to our residents. Responsibilities Responsibilities: As a part of the Sunrise team, supporting our Mission, Principles of Service and Core Values is a fundamental part of this job. Our foundational belief is the sacred value of human life. The unique responsibilities for this role include but are not limited to the essential...

Overview The LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe organized manner. Responsibilities include but are not limited to administration of medications, documentation of medication administration, conducting SHUs, and providing resident care while demonstrating the Mission for Sunrise Senior Living, “to champion the quality of life for all seniors” in accordance with federal, state/provincial, and local laws, standards and regulations and Sunrise Senior Living policies to promote the highest degree of quality care and services to our residents. Responsibilities   Part Time Overnight position available!     Responsibilities: As a part of the Sunrise team, supporting our Mission, Principles of Service and Core Values is a fundamental part of this job. Our foundational belief is the sacred value of human life. The unique responsibilities for this role...

Overview "Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air." - Sunrise Leader     At Sunrise, our Senior Resident Care Director (Sr. RCD) is responsible for providing overall leadership and management of the health and well-being of the residents within the community to which they are assigned to. Responsibilities   Responsibilities: - Managing all clinical programs, quality assurance and regulatory compliance - Assisting in the training and on-boarding of clinical and care coordinator team members - Assisting and partnering with the Regional Director of Resident Care to provide Medication Care Manager training (in states where allowed), Nursing at-Sunrise training and any other care and service training   Qualifications: - Maintains current state license as a...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...

We’re unique.  You should be, too. We’re changing lives every day.  For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts?  Do you inspire others with your kindness and joy? We’re different than most primary care providers. We’re rapidly expanding and we need great people to join our team. ChenMed, a physician-led and mission-driven, primary care organization, is currently one of the most successful full-risk Medicare Advantage providers in the nation and has a vision to be America’s leading primary care provider, transforming care of the neediest population. Our mission is to honor seniors with affordable VIP care that delivers better health. In order to achieve our vision and deliver our mission, we need the best primary care providers that are seeking to fulfill purpose and personal opportunity and join the ChenMed family. The Primary Care Physician (PCP) in our organization...