The Henry M. Jackson Foundation for the Advancement of Military Medicine
Regulatory Affairs Specialist - Murtha Cancer Center Research Program
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland, us, 20811
Regulatory Affairs Specialist - Murtha Cancer Center Research Program
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 supports the John P. Murtha Cancer Center Research Program (MCCRP) at the Uniformed Services University of the Health Sciences (USUHS). The MCCRP at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility with a core team of military and civilian oncologists and researchers delivering multidisciplinary cancer care. The incumbent will work as a Research Nurse for MCCRP cancer patients in the following areas: Surgical Oncology, Pulmonary Oncology, and Urologic Oncology.
About HJF: The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We support military, medical, academic and government clients by administering, managing and supporting scientific programs that benefit members of the armed forces and civilians alike.
Responsibilities
Assist with the development and IRB submission of research protocol applications and consent forms on behalf of the study Principal Investigator; assist in protocol writing, obtaining required approvals, and all phases of the protocol lifecycle to ensure amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
Maintain protocol and regulatory documents; ensure study compliance with local, state, federal, and DoD regulations for human subjects’ research with direction from USUHS, WRNMMC and HJF; maintain complete and accurate regulatory-compliant study binders.
Assist with initiation, tracking, management, and close-out of research; complete monitoring reports and follow-up letters, providing summaries of significant findings, deviations, deficiencies, and recommended 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; inform site staff of entry errors; ensure Good Clinical Practices (GCP) are adhered to and communicate protocol deviations per SOP, GCP and regulatory requirements.
Perform tasks related to the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; track MCCRP publications and provide regular reports.
May perform other duties as assigned, 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 and attention to detail.
Strong organizational and time management skills.
Excellent communication and interpersonal skills; able 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 requirement: 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 health and well-being, including medical, dental, and vision coverage, health savings accounts where applicable, retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include contacting professional 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, in lieu of stated minimums, require prior approval of the Chief Human Resources Officer.
Equal Opportunity The Henry M. Jackson Foundation is an Equal Opportunity Employer/Protected Veterans/Individuals With Disabilities. The contractor will not discriminate against applicants or employees for inquiries about compensation, except as permitted by law. For details, see 41 CFR 60-1.35.
About Us 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.
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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 supports the John P. Murtha Cancer Center Research Program (MCCRP) at the Uniformed Services University of the Health Sciences (USUHS). The MCCRP at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility with a core team of military and civilian oncologists and researchers delivering multidisciplinary cancer care. The incumbent will work as a Research Nurse for MCCRP cancer patients in the following areas: Surgical Oncology, Pulmonary Oncology, and Urologic Oncology.
About HJF: The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We support military, medical, academic and government clients by administering, managing and supporting scientific programs that benefit members of the armed forces and civilians alike.
Responsibilities
Assist with the development and IRB submission of research protocol applications and consent forms on behalf of the study Principal Investigator; assist in protocol writing, obtaining required approvals, and all phases of the protocol lifecycle to ensure amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
Maintain protocol and regulatory documents; ensure study compliance with local, state, federal, and DoD regulations for human subjects’ research with direction from USUHS, WRNMMC and HJF; maintain complete and accurate regulatory-compliant study binders.
Assist with initiation, tracking, management, and close-out of research; complete monitoring reports and follow-up letters, providing summaries of significant findings, deviations, deficiencies, and recommended 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; inform site staff of entry errors; ensure Good Clinical Practices (GCP) are adhered to and communicate protocol deviations per SOP, GCP and regulatory requirements.
Perform tasks related to the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; track MCCRP publications and provide regular reports.
May perform other duties as assigned, 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 and attention to detail.
Strong organizational and time management skills.
Excellent communication and interpersonal skills; able 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 requirement: 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 health and well-being, including medical, dental, and vision coverage, health savings accounts where applicable, retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include contacting professional 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, in lieu of stated minimums, require prior approval of the Chief Human Resources Officer.
Equal Opportunity The Henry M. Jackson Foundation is an Equal Opportunity Employer/Protected Veterans/Individuals With Disabilities. The contractor will not discriminate against applicants or employees for inquiries about compensation, except as permitted by law. For details, see 41 CFR 60-1.35.
About Us 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.
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