65 regulatory coordinator jobs found in Boston, MA

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Breast Oncology 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...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, 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...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Head & Neck Oncology 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...

The Regulatory Coordinator II (RC II) will work under the direction of the Director of Clinical Research Administration for the Clinical Trials Office to complete the regulatory requirements of the clinical research projects. 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’s work location is hybrid...

Reporting to the Practice Manager, this mission critical position is responsible for departmental administrative tasks and the review of complex patient appointment sets and associated lab work. The Lab Services Coordinator (LSC) works in a busy environment with a high patient volume, managing complex tasks while balancing multiple real-time priorities, and, when appropriate, acting as the escalation point for issues presenting at main reception. The LSC is an ambassador of the DFCI patient experience while efficiently managing the patient check-in process; uploading outside imaging into Epic, being responsible for offering exemplary customer service and resolving and triaging issues presented during both face-to-face or telephone interactions. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related...

The Pharmacy Department at the Dana-Farber Cancer Institute places emphasis on the values of reliability, professionalism, cooperation, teamwork, communication, positivity and inclusiveness. The Pharmacy Technician III, Infusion is responsible for providing technical support to pharmacy operations under the supervision of a licensed pharmacist. The Pharmacy Technician III, Infusion will staff in pharmacy locations/areas as required. Additional responsibilities may include regulatory and compliance duties, projects, and conducting the training and orientation processes of new pharmacy employees. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all...

The CRC (Clinical Research Coordinators) work within the Head & Neck Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with...

Investigators in the Division of Cancer Genetics and Prevention at the Dana-Farber Cancer Institute seek a full-time Clinical Research Coordinator to assist in clinical and non-clinical research studies related to cancer prevention, genetic testing, early identification of individuals at high-risk of cancer, and biorepository collections. This is an exciting and challenging opportunity for an individual who is motivated to work in an innovative academic center on cutting edge genetics research, and is interested in working directly with patients, providers, and researchers. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design...

Investigators in the Division of Cancer Genetics and Prevention at the Dana-Farber Cancer Institute seek a full-time Clinical Research Coordinator to assist in clinical and non-clinical research studies related to cancer prevention, genetic testing, early identification of individuals at high-risk of cancer, and biorepository collections. This is an exciting and challenging opportunity for an individual who is motivated to work in an innovative academic center on cutting edge genetics research, and is interested in working directly with patients, providers, and researchers. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. Located in Boston and the surrounding communities, Dana-Farber Cancer...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. The float research nurse will be expected to float to various disease groups....

The CRC (Clinical Research Coordinators) work within the Breast Oncology Cohort Studies clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants...

The CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. Located in Boston and the surrounding communities, Dana-Farber Cancer...

The Director of Nursing is responsible for the planning, implementation and evaluation of clinical operations and personnel management of the assigned patient care unit.  He/she acts as a liaison between the various clinical departments, disciplines and patient services to ensure continuity. Specific duties and responsibilities may vary across programs and areas.  Plans, organizes, and directs the operations and quality improvement program for the assigned unit(s) in collaboration with the disease center leaders, clinical and administrative directors. This is accomplished by employing multidisciplinary teams to design, implement and monitor systems that will provide for the highest quality patient experience while maximizing provider time and space utilization. The Nurse Director uses extensive theoretical, evidence-based, and experiential knowledge to advance clinical practice, provides clinical leadership and direction, and promotes professional growth for self and staff. The...

The CRC (Clinical Research Coordinator) works within the Cancer Genetics and Prevention program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. Located in Boston and the surrounding communities, Dana-Farber Cancer...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. Located in Boston and the surrounding communities, Dana-Farber Cancer...

The Zakim Center for Integrative Therapies and Healthy Living is recruiting a Clinical Research Coordinator II (CRC II). The CRC II is a critical member of the research team who will work on research projects focused on exercise and nutrition interventions to support oncology patients and survivors. The CRC II will work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Associate Director of Research Operations. The CRC II will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol, including administering exercise and physical function testing. CRC II may also be responsible for the collection of protocol related samples including shipment to outside entities as applicable. Will support...

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of cancer as a disease process, cancer treatment modalities (or comparable knowledge for a non-oncology area, e.g. infection control) and the process of conducting medical clinical research. In addition, the CRN utilizes evidence-based nursing practice and has expertise in developing and coordinating a plan of care designed to meet the physical, psychological, and social needs of those cancer patients and their families undergoing therapy in a clinical research trial. Strong interpersonal, organizational and communication skills are required. Knowledge of current literature and a commitment to continued learning are also required. Specific duties and responsibilities may vary across the different programs/areas. The float research nurse will be expected to float to various disease groups....