Research Coordinator III - RMO

Join the HJF Team!

HJF is seeking a Research Coordinator III to develop, edit, document, and package protocols, consent forms and other regulatory documents for assigned medical centers, and special projects. Responsible for the execution and completion of protocol compliance actions leading to final IRB Approval. Specifically responsible for study start-up activities and regulatory management of industry sponsored, FDA regulated clinical trials.

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.
• Coordinates efforts of all agencies involved in the protocol approval process. Makes and maintains contacts within the pharmaceutical industry.
• Coordinates protocol-specific training to study site staff and investigators. Ensures all human research protection (HRP) education is current, per study/project needs. Assists and leads in the drafting standard operating procedures (SOPs), coordinating in-services with clinical and research staff, and maintaining training logs within the scope of the research projects.
• Provides direction, feedback and evaluation of research support personnel, to include junior research coordinators and/or assistants.
• Collaborates with the Program Director and Managers to assess, evaluate and maintain training standards and to address the educational needs of the staff. Provide regulatory guidance and training to employees as needed.
• 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.

Supervisory Responsibilities

• Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.

Education and Experience

• Bachelor's Degree in a science related field.
• Minimum of 6-8 years experience required. At least 1-2 years of clinical research experience preparing IRB submissions strongly preferred.

Required Knowledge, Skills and Abilities

• Clinical research experience required, especially with FDA regulated clinical trials and IRB submissions.
• Working knowledge of a broad range of medical specialties and familiarity with medical terminology required.
• 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 have excellent interpersonal and communication skills, be able to set and meet deadlines, coordinate multiple projects at once, and independently interpret issues and determine the best path forward.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Physical Capabilities

• Ability to stand or sit at a computer for prolonged periods

Work Environment

• This position will take place primarily in an office setting.

Compensation

• The annual salary range for this position is $67,500-$96,000. 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.

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.