Regulatory Compliance Specialist - SC2i

• Assists with the regulatory review of research protocols and study documentation to ensure compliance with federal, institutional, and consortium requirements governing human subjects research, and HIPAA-protected information.
• Prepares, submits, and manages research protocols through institutional electronic review systems (eIRB), assists with resolving reviewer comments and regulatory stipulations to secure timely study approval.
• Monitors regulatory requirements, guidance documents, and policy updates from federal agencies and oversight bodies, assessing their impact on SC2i research activities and recommending compliance actions.
• Enters and updates protocol, approval, and study status information in SC2i regulatory tracking systems and databases to maintain complete and current records.
• Reviews assigned regulatory documents for completeness and formatting accuracy, under the direction of senior regulatory staff, to support submission readiness.
• Assists with the preparation, review, execution, and maintenance of Data Sharing Agreements (DSAs), Material Transfer Agreements (MTAs), and Data Use Agreements (DUAs) to support compliant collaboration and data-sharing activities.
• Maintains regulatory tracking systems and administrative records across the assigned portfolio to monitor submission status, approvals, renewals, and reporting requirements.
• Prepares, submits, and maintains ClinicalTrials.gov registrations and study records in accordance with federal reporting requirements to ensure transparency and compliance under direction of the Senior Manager, Regulatory and Laboratory Compliance.
• Monitors reporting deadlines and study milestones, coordinating with investigators and study teams to keep trial records accurate and current.
• Develops, revises, and maintains Standard Operating Procedures (SOPs), Standard Operating Guidelines (SOGs), and regulatory process documents to promote consistency across consortium operations under direction.
• Maintains regulatory files, correspondence, approvals, and supporting documentation in accordance with applicable record retention requirements to ensure audit readiness and document traceability.
• Conducts periodic reviews of regulatory documentation and tracking systems to verify completeness, accuracy, and compliance with institutional and sponsor requirements.
• Maintains collaborative relationships with investigators, IRBs, regulatory offices, and consortium partners to facilitate effective communication and regulatory coordination across SC2i sites.
• Assists with regulatory compliance training for research personnel, monitoring completion records and communicating training obligations.
• Supports organizational compliance initiatives by participating in regulatory meetings, educational activities, and continuous improvement efforts that strengthen the SC2i research compliance program.
• Communicates with investigators and research staff, under supervision, to collect required documentation and relay basic regulatory status updates.

Join the HJF Team!

HJF is seeking a Regulatory Compliance Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research and Health Insurance Portability and Accountability Act (HIPAA).

This position will be in support of the Surgical Critical Care Initiative, USU Department of Surgery. The Surgical Critical Care Initiative (SC2i), funded by the Department of Defense was established in 2013. SC2i is a Uniformed Services University center that leverages legacy information from service members, and critically ill civilian and military patients to develop biomarker-driven clinical decision support tools (CDSTs) with the goal of improving patient clinical outcomes and reducing costs across the injury/disease cycle.

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.