Research Compliance Scientist IV

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

The Research Compliance Scientist IV shall provide real-time support to JPEO-CBRND-supported research protocols through timely coordination on reviews of protocol lifecycle actions to ensure ongoing compliance with all applicable Federal, Department of Defense (DoD), Food and Drug Administration (FDA), Department of the Army (DA), state, and host nations.

Essential Job Functions:

• Foster regulatory compliance through education and training of investigators, research managers, administrators, and JPEO-CBRND staff, and provide assistance to program offices and investigators with interpretation of human subjects' protection, cadaver use, and animal research compliance requirements
• Acquire and retain knowledge of current Federal, DoD, FDA, Army, state, host nation regulatory requirements related to the protection of human subjects in research and cadaver use and animal research compliance.
• Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects' protection regulations and requirements
• Participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approvals processes, and provide input and assistance with formulating and writing human and animal research compliance standard operating procedures and work instructions
• Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded performers developing MCMs are complying with relevant laws, regulations, and current guidance's pertaining to research protection compliance
• Serve as a subject matter expert in human and animal research compliance at the working group-level.
• Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS regulatory office on critical programmatic and project level regulatory challenges.
• Provide training and advisement to JPEO-CBRND staff on regulations, interactions with research protection authorities
• Review, draft, manage, maintain and retain documentation and training records in accordance with approved business rules in the assigned electronic document management system.
• Contribute to the modification, development and implementation of internal policies and procedures.
• Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues Assist with contracting action reviews to ensure inclusion of research protection clauses
• Collaborate and network with internal/external research protection SMEs, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
• Ability to become an expert at applying DOD, Army human subjects protection and animal research compliance and use regulations, policies and guidelines.
• Travel for presentations and seminars.

Necessary Skills and Knowledge:

• Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for review and oversight.
• Working knowledge of ethical principles related to participation of humans in research.
• Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
• Proficiency with Microsoft Office Suite.
• Ability to become proficient in the use of electronic document management and review system.
• Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.
• Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices.

Minimum Qualifications:

• Minimum 2+ years of related human subjects protection experience.
• Ability to travel.
• Clearance: Secret

Pay and Benefits

The salary range for this position is $80,000- $100,000 annually.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.