The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
Regulatory Affairs Specialist - Murtha Cancer Center Research Program
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, us, 20811
Overview
Join the HJF Team! HJF is seeking a
Regulatory Affairs Specialist
to assist in the compliance of MCCRP research protocols with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and HIPAA. This position will support the John P. Murtha Cancer Center Research Program (MCCRP) of the Uniformed Services University of the Health Sciences (USUHS). The John P. Murtha Cancer Center Research Program at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility. Its comprehensive core of military and civilian oncologists and other cancer-trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services. Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies. The incumbent will work as a Research Nurse for MCCRP cancer patients in the following areas: Surgical Oncology, Pulmonary Oncology, and Urologic Oncology. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF\'s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities
Assist with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Investigator. Assist in protocol writing, obtaining the required institutional approvals, and all phases of the protocol lifecycle to ensure that protocol amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
Maintain protocol and regulatory documents in alignment with local, state, federal, and DoD regulations for human subjects\' research with regulatory direction from USUHS, WRNMMC and HJF. Maintain complete and accurate regulatory-compliant program/study binders.
Assist with initiation, tracking, management, and close-out of research studies. Complete monitoring reports and follow-up letters, providing summaries of significant findings, deviations, deficiencies, and suggested actions to obtain compliance.
Assist with collecting and monitoring required research training certifications and other study personnel documents for MCCRP investigators and study team.
Perform quality control and source documentation verification against case report form data, communicate any entry errors to site staff, ensure adherence to Good Clinical Practices (GCP), and report protocol deviations per SOPs and applicable regulatory requirements.
Support the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; track MCCRP scientific publications and provide regular reports to the institution.
May perform other duties and responsibilities as assigned by the supervisor, including attendance at required training for the role.
Education and Experience
Bachelor\'s Degree is required.
Minimum of 3-5 years of experience required.
Required Knowledge, Skills and Abilities
Basic knowledge of human subjects\' research regulations.
Experience working on regulatory items for research protocols.
Excellent writing skills (ability to clearly and concisely explain scientific and technical ideas in simple language). Attention to detail.
Strong organizational and time management skills.
Excellent communication and interpersonal skills (ability to interact effectively with experts in medical, academic, research, technical, military, and administrative fields).
Oncology experience is a plus.
Proficiency with MS Word, Excel, PowerPoint, and Adobe.
Security Requirements: Ability to obtain and maintain a T1 public trust background investigation.
Work Environment
This position will take place primarily in an office setting.
Compensation
The annual salary range for this position is $64,200-$100,000. Actual salary will be determined based on experience, education, etc.
Benefits
HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include references, verification of previous employment, education and credentials, a criminal background check, and a DMV check if applicable. Any qualifications to be considered as equivalents require prior approval of the Chief Human Resources Officer.
Equal Opportunity Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. The contractor will not discriminate against employees or applicants for discussing or disclosing pay information, except as permitted by law. 41 CFR 60-1.35
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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Join the HJF Team! HJF is seeking a
Regulatory Affairs Specialist
to assist in the compliance of MCCRP research protocols with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and HIPAA. This position will support the John P. Murtha Cancer Center Research Program (MCCRP) of the Uniformed Services University of the Health Sciences (USUHS). The John P. Murtha Cancer Center Research Program at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility. Its comprehensive core of military and civilian oncologists and other cancer-trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services. Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies. The incumbent will work as a Research Nurse for MCCRP cancer patients in the following areas: Surgical Oncology, Pulmonary Oncology, and Urologic Oncology. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF\'s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities
Assist with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Investigator. Assist in protocol writing, obtaining the required institutional approvals, and all phases of the protocol lifecycle to ensure that protocol amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
Maintain protocol and regulatory documents in alignment with local, state, federal, and DoD regulations for human subjects\' research with regulatory direction from USUHS, WRNMMC and HJF. Maintain complete and accurate regulatory-compliant program/study binders.
Assist with initiation, tracking, management, and close-out of research studies. Complete monitoring reports and follow-up letters, providing summaries of significant findings, deviations, deficiencies, and suggested actions to obtain compliance.
Assist with collecting and monitoring required research training certifications and other study personnel documents for MCCRP investigators and study team.
Perform quality control and source documentation verification against case report form data, communicate any entry errors to site staff, ensure adherence to Good Clinical Practices (GCP), and report protocol deviations per SOPs and applicable regulatory requirements.
Support the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; track MCCRP scientific publications and provide regular reports to the institution.
May perform other duties and responsibilities as assigned by the supervisor, including attendance at required training for the role.
Education and Experience
Bachelor\'s Degree is required.
Minimum of 3-5 years of experience required.
Required Knowledge, Skills and Abilities
Basic knowledge of human subjects\' research regulations.
Experience working on regulatory items for research protocols.
Excellent writing skills (ability to clearly and concisely explain scientific and technical ideas in simple language). Attention to detail.
Strong organizational and time management skills.
Excellent communication and interpersonal skills (ability to interact effectively with experts in medical, academic, research, technical, military, and administrative fields).
Oncology experience is a plus.
Proficiency with MS Word, Excel, PowerPoint, and Adobe.
Security Requirements: Ability to obtain and maintain a T1 public trust background investigation.
Work Environment
This position will take place primarily in an office setting.
Compensation
The annual salary range for this position is $64,200-$100,000. Actual salary will be determined based on experience, education, etc.
Benefits
HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include references, verification of previous employment, education and credentials, a criminal background check, and a DMV check if applicable. Any qualifications to be considered as equivalents require prior approval of the Chief Human Resources Officer.
Equal Opportunity Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. The contractor will not discriminate against employees or applicants for discussing or disclosing pay information, except as permitted by law. 41 CFR 60-1.35
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
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