Research Coordinator II - Research Management Office

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Bethesda (MD); On-site; USD 40,000 - 55,000; Full time

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) seeks a Research Coordinator II to manage regulatory documents and protocol submissions across assigned medical centers.

The role involves writing, editing, and packaging protocols, consent forms, IRB submissions, and supporting final IRB approval. Based in Bethesda, MD, the position supports the Research Management Office with regulatory oversight, budgeting coordination where applicable, and ensuring

Qualifications

• Bachelor's degree required in a related scientific field.
• 3–5 years of experience required.
• 1–2 years of clinical research experience preparing IRB submissions preferred.
• Working knowledge of federal and military regulations governing human/animal subjects in research.
• US Citizenship and ability to obtain/maintain a T3/Secret Clearance.

Responsibilities

• Writes protocol applications and consent forms for IRBs and prepares required documents.
• Manages regulatory issues after IRB approval and submits annual reports and safety information.
• Performs background research to support protocol submissions.
• Negotiates contracts and develops study budgets.
• Coordinates activities of agencies involved in protocol approval and maintains sponsor communications.
• May have budgetary responsibilities and required trainings.

Skills

IRB submissions

Regulatory compliance

Clinical research

Deadline management

US Citizenship

Security clearance

Education

Bachelor's degree in a related scientific field

Job description

Join the HJF Team!

HJF is seeking a Research Coordinator II to write, edit, document, and package protocols, consent forms and other regulatory documents for all assigned medical centers. Responsible for protocols from all sponsors (federal and non-federal) and completing all actions for the protocol to receive final IRB Approval.

This position will be in support of the Research Management Office (RMO), located at the Home Office in Bethesda, MD. This office provides scientific, technical, and programmatic support services to various domestic military sites in initiating and managing clinical research studies.

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.

• Writes protocol applications and consent forms for Institutional Review Boards. Prepares and submits required institution and federal documentation for the conduct of the trial.
• Manages regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintains accurate, regulatory-compliant program/study binders.
• Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions.
• Negotiates contracts and develops cost-per-patient study budgets.
• Coordinate's efforts of all agencies involved in the protocol approval process. Makes and maintains contacts within the pharmaceutical industry.
• If applicable: May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
• 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.

Education and Experience

• Bachelor's Degree in a related scientific field required.
• Minimum of 3-5 years experience required.
• At least 1-2 years of clinical research experience preparing IRB submissions strongly preferred.

Required Knowledge, Skills and Abilities

• Working knowledge of a broad range of medical specialties.
• Working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314, 45 CFR 46, FDA Form 1571, and FDA Form 1572).
• Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions.
• Must be able to set and meet deadlines.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Work Environment

• This position will take place primarily in a office/laboratory setting.

Compensation

• The hourly pay range for this position is $29.33-$40.87. Actual hourly pay 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.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.