Regulatory Affairs Specialist - WHIRC

About the Role

HJF is seeking a Regulatory Affairs Specialist-WHIRC to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This is the first level in the Regulatory Affairs series. This position will support the GYN Center of Excellence (Annandale, Virginia) part of the John P. Murtha Cancer Center Research Program (MCCRP) of the Uniformed Services University of the Health Sciences (USUHS).

Responsibilities

• Assists with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Investigator.
• Assists 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.
• Ensures that protocol and regulatory documents are maintained and are kept up to date.
• Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC and HJF.
• Maintains complete and accurate regulatory-compliant program/study binders.
• Assists with initiation, tracking, management, and close-out of research studies.
• Completes monitoring reports and follow-up letters, providing summaries of the significant findings, deviations, deficiencies, and suggesting actions to obtain compliance.
• Assists with collecting and monitoring required research training certifications and other study personnel documents for MCCRP investigators and study team members.
• Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures (SOP), GCP and applicable regulatory requirements.
• Performs tasks associated with the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; tracks MCCRP scientific publications and provides regular reports to institutional leadership.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Qualifications

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
• Excellent writing skills (able to clearly and concisely explain scientific and technical ideas in simple language)
• Attention to detail
• Strong organizational skills and strong time management skills
• Excellent communication and interpersonal skills (able to interact and communicate effectively with experts in medical, academic, research, technical, military, and administrative fields)
• Proficiency with computer applications such as MS Word, Excel, PowerPoint, and Adobe Acrobat
• Ability to obtain and maintain a T1/Public Trust Background Check

Licenses and Certifications

Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.

Work Environment

This position will take place primarily in an office setting.

Compensation

The annual salary range for this position is $67,500 - $97,000. 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.