Clinical Research Coordinator II (Respiratory) - The Henry M. Jackson Foundation for the Advancement of Military Medicine

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator II  to adhere to legal, professional, and ethical codes regarding confidentiality and privacy, and to help ensure that protocol requirements are achieved within Good Clinical Practices.

This position directly supports the Department of Pediatrics and collaborates closely with the Department of Medicine, both located at the Uniformed Services University (USU) in Bethesda, MD. The Clinical Research Coordinator II supports studies sponsored by the Department of Pediatrics at the Uniformed Services University of the Health Sciences (USU) and led by USU researchers.

The current pediatric research effort centers on a project aimed at examining how the pediatric immune system reacts to SARS-CoV-2, influenza, or RSV. HJF provides scientific, technical, and programmatic support services to the Pediatric Department to conduct this research.

This position will also provide coordinated support to the Translational Medicine Unit (TMU) within the Department of Medicine at the Uniformed Services University (USU). The TMU is an outpatient clinical research center at USU on the campus of the Walter Reed National Military Medical Center (WRNMMC). The TMU conducts sponsored research in partnership with numerous stakeholders within USU and external industry partners. The TMU supports the clinical stage development of medical products by advancing scientific knowledge regarding clinical outcomes, with a particular focus on product safety.

This position requires the incumbent to work closely alongside Principal Investigators and senior research leaders to assist in performing clinical research in support of various clinical research protocols. The incumbent will adhere to legal, professional, and ethical codes concerning confidentiality and privacy. The incumbent will help ensure protocol requirements are achieved within Good Clinical Practices. The desired candidate will also have laboratory processing knowledge or the ability to learn how to support the research team in sample collections and preparations. The incumbent will perform work in compliance with and according to established guidelines and quality control standards. The incumbent will work closely with the Principal Investigator (PI) to organize the research team, ensure team trainings are completed, and maintain exceptional study related records.

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.

Note: This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years. 

• Coordinate protocol applications and consent forms for Institutional Review Boards. Prepare and submit required institutional and federal documentation for the conduct of the trial.
• Manage 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, and updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintain accurate, regulatory-compliant program/study binders.
• Coordinate efforts among all agencies involved in the protocol approval process.
• Review new participant records and screen participants for eligibility in research protocols.
• Interview participants for protocols and collect and analyze appropriate data for recruitment purposes, determine participant commitment, and obtain informed consent.
• Educate participants about the research protocol, their roles in the protocols, and any other vital information.
• Collect, organize, catalog, disseminate, and maintain appropriate files of current data. Maintain weekly/monthly status reports on all participants. Educate participants about the clinical trial, their roles in the protocols, and any other vital information. Serve as a resource for participants and act as a liaison between participants and physicians.
• Ensure all human research protection (HRP) education is current, per study/project needs. Assist and lead in drafting standard operating procedures (SOPs), coordinating in-services with clinical and research staff, and maintaining training logs within the scope of the research projects.
• Collaborate with the Program Director and Managers to assess, evaluate, and maintain training standards and address the educational needs of the staff. Provide regulatory guidance and training to employees as needed.
• Transcribe and resolve queries of data in case report forms (hardcopy or electronic) and prepare documents under the direction of project heads.
• Schedule participants for appointments and visits. Assist with monitoring audits/visits for protocols.
• Create and maintain accurate documents and records in multiple databases/software programs.
• Coordinate and assist program management and investigators on the regulatory and clinical inputs on contracts and develop cost-per-participant study budgets.
• Adhere to legal, professional, and ethical codes with respect to confidentiality and privacy.
• Ensure protocol requirements are achieved within Good Clinical Practices.
• May perform laboratory procedures to assist supervisors with various tests, assays, and experiments.
• May be trained to perform clinical procedures to including vital signs, phlebotomy, and nasopharyngeal sample collection.
• Maintain laboratory equipment and perform general procedures such as monitoring, calibration, and preventative maintenance. Compile, coordinate, and assist in the collection, processing, and submission of data in a timely and organized manner.
• May provide direction, feedback, and evaluation of research support personnel, including junior research coordinators and/or assistants.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance at and participation in required training for the role.

Education and Experience

• Bachelor's Degree
• Minimum of 3-5 years experience required

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 familiar with phlebotomy, preferably pediatric.

• Must possess excellent interpersonal and collaborative skills.

• Flexibility and self-direction in a dynamic research environment.

• Mastery of basic functions in Word, PowerPoint, Google Drive, Google Meet, Excel.

• Capacity to learn advanced functions in Word, PowerPoint, Google Drive, Google Meet, and Excel to support research efficiency.

• Ability to communicate effectively and work with individuals at all levels.

• Regulatory and research experience with infectious diseases is preferred.

• Clinical skills experience with vital sign measurement, and nasal specimen collection is preferred.

• Comfort with engagement with pediatric participants is preferred.

Physical Capabilities 

• Lifting: Requires lifting materials up to 10 lbs.

Work Environment

• This position will take place primarily in a Clinic setting. 

Compensation

• The annual salary range for this position is $57,650-$80,000. 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.

Security Requirements: Ability to obtain and maintain a T1 Public Trust Investigation.

Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

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.