Navy Research Compliance Officer- (Security Clearance Preferred) Secre

Job Title: Navy Research Compliance Officer- (Security Clearance Preferred) Secret or TS/SCI

Location: Silver Spring, MD

• Department: Office of Research Administration (ORA) at the Naval Medical Research Center

Additional: (Security Clearance Preferred) Secret or TS/SCI

Contract: Ravens Group, Inc./ Supporting- The Office of Research Administration (ORA) at the Naval Medical Research Center

Period of Performance: TBD- Starting early 2023

Start Date: Start date- TBD-2023

Salary: Great salary (TBD)

Clearance Requirement: The candidate will need to submit a background clearance application for T3 clearance this is mandatory, Public Trust are no longer accepted must be US citizens. (Security Clearance Preferred) Secret or TS/SC.

Note: The Ravens Group, Inc. request that all interested parties complete the attached questionnaire in order to be considered for position.

The Ravens Group, Inc. is in an active bidding process for this position, which is contingent upon The Ravens Group, Inc. being awarded the contract.

Scope of Work:

• The purpose of this contract is to serve as the Research Compliance Officer for the Office of

Research Administration (ORA) at the Naval Medical Research Center (NMRC).

• The candidate shall develop, implement, and maintain compliance and training activities for the NMRC Human

Research Protection Program.

• The objective of this task is to provide guidance and counsel on

  incorporating compliance-related activities into the day- to-day operations of the Human Research

  Protection Program.

• The work is to ensure regulatory and policy updates are disseminated to

investigators and research staff in a timely manner, perform ongoing monitoring of all areas of

research compliance, and act decisively on issues of potential non-compliance.

• This position will oversee the education and training process for research and non-research employees regarding

compliance-related activities.

• Duties will encompass three major areas of regulatory compliance relevant to the NMRC Research and Development Program. These areas are:

1) protection of human

subjects in research,

2) biosafety, and

3) conflict of interest.

The candidate must possess a broad knowledge of the interrelated Federal and State laws/regulations governing each of these four

areas.

The candidate ensures that records contain all documentation required by the Bureau of

Medicine and Surgery (BUMED), Food and Drug Administration (FDA), and the Department of

Health and Human Services (DHHS) regulations.

He/she coordinates the preparation for surveys and site visits.

Protection of Human Subjects Involved in Research:

• Works closely with the Chairman, Institutional Review Board (IRB), NMRC, Head,
• ORA, the Institutional Review Board (IRB) key personnel, and investigators to ensure compliance with laws and regulations promulgated to ensure the protection of human subjects in research.
• The contractor focuses especially on Department of Defense (DoD), DHHS, National Institutes of Health (NIH), and FDA policies.
• Communicates verbally and in writing with researchers to advise them on policy matters, process issues, and procedural requirements for conducting research involving humans.
• Develops and revises, as necessary, written procedures and documents implementing the regulations.
• The candidate monitors compliance with approved procedures and regulations by administration and by investigation.
• Monitoring includes, but is not limited to, reviewing completeness and compliance of research consent process, forms, and human research logbooks, with all applicable federal regulations.
• Responds to requests from the Department of the Navy Human Research
• Protections Program (DON HRPP).
• Develops a compliance training program, ensuring it meets regulatory requirements, and ensures that it is completed by appropriate staff members. Biosafety:
• The candidate works closely with the Research Safety Coordinator, Chairman, Institutional Biosafety Committee, and the Radiation Safety Officer to assure compliance with current DoD and DHHS regulations.
• Conflict of Interest Program:
• The candidate participates actively in implementing federal regulations on Conflict of Interest.
• The candidate will also assist in coordinating any inquiry or investigation of alleged conflict of interest.
• Special Projects: -
• Grants and Proposals: Reviews applications for regulatory compliance as needed.
• Attends and participates in appropriate meetings.
• Performs analytical and evaluative work associated with program activities.
• Audits, Inspections and Management Controls:
• Develops procedures and systems for establishing, operating, and assessing the effectiveness of compliance control systems and the accomplishment; evaluation and/or monitoring of audits, inspections, or management of internal control reviews.
• Evaluates results of audits/inspections and forwards action items to the Head, ORA. Performs audits of research records related to human subject protections and maintains these records as required for compliance.
• Maintains research records in conditions suitable for BUMED, FDA, DHHS inspections.
• Evaluates and updates standard operating procedures (SOPs) to maintain compliance with applicable federal regulations and accreditation requirements.
• Performs quality assurance work that involves systematic prevention of non-conformance to regulations and standards, identification of unsatisfactory trends and conditions, and correction of factors that may contribute to non-compliance.
• Performs quality management activities that are designed to improve quality of transaction processing, customer service activities or other compliance procedures, or performs quality assurance activities for proposals and grants.
• Performs a variety of duties to carry out, administer or advise on work concerned with assuring full compliance in each of the three compliance programs (human subject protections, biosafety, and conflict of interest).
• Program Oversight:
• Analyzes and evaluates, on a quantitative and/or qualitative basis, the effectiveness of programs or operations in meeting established compliance goals and objectives.
• Analyzes program performance data to identify slippage and impact.
• Analyzes and prepares program status reports for review at all levels.
• Works with the Head, ORA to develop policy, regulations and/or standards covering programs, activities, of functions for which the service has responsibility and as they relate to compliance issues.
• Analyzes new BUMED and other regulatory agency directives, policies and guidance and provides input into sections of proposed administrative regulations that will meet the regulatory requests.
• Standards, Regulations, or Policy Development: Analyzes the impact, feasibility, practicality, and effectiveness of existing and/or proposed standards, regulations, programs, and policies as they relate to compliance issues.
• Identifies key policy issues, designs analyses, evaluates alternatives, and makes recommendations to the Head, ORA.
• Regulatory/Policy Development:
• Analyzes new or amended legislation, and develops regulations, policies and/or standards covering programs, activities, or functions for which the service has responsibility.
• Analyzes new regulatory agency directives, policies and guidance and provides input into sections of proposed administrative regulations that will meet the regulatory requests at the local level.
• This input may be to new regulations or changes to existing regulations.
• Studies and Special Projects:
• Identifies opportunities to improve compliance and designs studies, training programs and organizational strategies to achieve the goal.
• Identifies discrete steps of simple transaction processes or routine business practices, which might be opportunities for applying compliance improvement techniques.
• Assists managers and technical specialists in identifying compliance areas with potential for significant compliance improvement.
• Facilitates innovative application of best practices and quality management methods.
• Training Sessions:
• Facilitates or coordinates training sessions in the three program areas.
• Ensures that a wide range of teaching methods and/or tools, depending on the students' learning requirements, are used for best results.
• Modifies training courses and course materials and plans for specific audiences.
• Determines the need for additional subject-matter information and recommends meetings with representative(s) of outside organizations in order to obtain it.
• Develops new or adapts existing training or testing materials for formal course use.

Qualifications:

• Bachelor's Degree in law, business administration or information science, Master's Degree preferred.
• Professional experience in research administration and/or research compliance.
• Extensive knowledge of federal research regulations pertaining to one or more of the following areas:

sponsored projects, research integrity, effort reporting, conflict of interest, human subjects research,

export control/controlled information, procurement, or record retention.

• Ability to successfully interpret and explain regulations and guidance given particular situations and

audiences: ability to assess regulatory issue impact on institutional business needs, researchers, and

research programs.

• Proven success in implementing compliance monitoring mechanisms.
• Exceptional written, verbal and interpersonal communication skills; demonstrated ability to effectively communicate complex issues both verbally and in writing.
• Demonstrated ability to design, develop, and deliver training.
• Ability to identify and use formal and informal decision-making networks, facilitate reconciliation of conflicts, and negotiate successful solutions.
• Successful record of working effectively and in partnership with individuals who do not report directly but have a shared responsibility for compliance.
• Demonstrated record of taking actions that support a commitment to equity, diversity and inclusion.
• Ability to support and promote an effective, ongoing regulatory compliance program.
• Thorough knowledge of compliance issues, laws and regulations relating to research compliance.
• Demonstrated highly effective interpersonal skills for working closely with internal organizational units and for effective representation of organizational positions on issues with external parties and groups.
• Ability to work independently on multiple issues concurrently and to exercise independent judgment in establishing priorities.
• Ability to organize work, make sound decisions and exercise good judgment.

The Ravens Group is an "equal opportunity employer/veteran/disability" organization.