Clinical Research Coordinator II - TraCR

The Henry M. Jackson Foundation for the Advancement of Military Medicine; Bethesda (MD); Sur place; USD 61 000 - 79 000; Plein temps

Résumé du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine seeks a Clinical Research Coordinator II to support translational and clinical research within NMRC CTC in Bethesda, MD. You will assist in protocol development, regulatory submissions, subject recruitment, and data management under senior supervision.

US citizenship is required. The role ensures compliance with Good Clinical Practice and involves training junior staff in a fast-paced, mission-focused environment.

Qualifications

• Bachelor's Degree in Life Sciences or related field.
• 3–5 years of experience in clinical research or CRC role.

Responsabilités

• Assist protocol development and study procedures with senior staff.
• Prepare and submit regulatory documents (IRB/ethics submissions).
• Recruit and screen subjects for NMRC CTC studies.
• Review records and determine eligibility for participation.
• Educate subjects about protocols and obtain informed consent.
• Monitor progress, report deviations and adverse events.
• Maintain data files and status reports for all subjects.
• Coordinate with clinicians and study teams across sites.

Connaissances

Regulatory submissions

Scientific terminology

Team coordination

MS Office proficiency

Attention to detail

Effective communication

Driver's license

Formation

Bachelor's Degree in Life Sciences

Outils

MS Office (Outlook/Excel/Word/Teams)

Adobe Acrobat

Description du poste

Join the HJF Team!

HJF is seeking a

Job Description

HJF is seeking a Clinical Research Coordinator II to assist in the conduct of clinical research in conjunction with one or more specified clinical research protocols. Developing adherence to legal, professional, and ethical codes with respect to confidentiality and privacy helps ensure that protocol requirements are achieved in accordance with Good Clinical Practice. This is the second of four levels for the Clinical Research Coordinator (CRC) series. This position will be in support of the Translational and Clinical Research Department (TraCR) within the Infectious Diseases Directorate (IDD) at the Naval Medical Research Command (NMRC). The incumbent is tasked with supporting and conducting high-quality translational and clinical research to facilitate the development of infectious disease countermeasures for US military personnel. Within the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials. The NMRC CTC evaluates vaccines, therapeutics, prophylactics, and medical devices in human subjects to suitably advance innovative products from the laboratory to the front line and maximize the medical readiness of the Warfighter. This position will work within the NMRC CTC to support those clinical trial activities.

Join the HJF Team!

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.

Responsibilities

• Assists human subjects’ research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the NMRC CTC in conjunction with senior staff.
• Prepares and submits regulatory documents, including scientific and institutional review board submissions.
• Recruits and screens new subjects for participation in clinical research studies occurring in the NMRC CTC.
• Reviews new subjects records and screens subjects for eligibility in participation of research protocol(s).
• Interviews subjects for protocols and collects and analyzes appropriate data for recruitment purposes, determine subject commitment and obtains informed consent. Educates subjects about the research protocol, their roles in the protocols, and any other vital information.
• Monitors study progress and identifies and resolves/reports issues, including protocol deviations and non-compliance, to the appropriate parties.
• Monitors, documents, and reports adverse events and safety concerns in accordance with regulatory and sponsor requirements.
• Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data. Maintains status reports on all subjects as appropriate.
• Acts as a liaison between subjects and clinicians and serves as a resource for the subjects.
• Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads.
• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are performed in compliance with Good Clinical Practice and other federal and local regulations.
• Schedules subjects for appointments and visits. Assists with monitoring audits/visits for protocols.
• Trains and mentors junior research staff as needed.
• Travels from their assigned workplace to support protocols at other sites as needed.
• 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.

Qualifications

Education and Experience

• Bachelor's Degree in Life Sciences or a related field required.
• Minimum of 3-5 years experience required.

Required Knowledge, Skills And Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects, to include regulatory submissions.
• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to work independently and as part of a team in a fast-paced environment.
• Excellent interpersonal and computer skills, including experience with MS Office products (MS Outlook, MS Excel, MS Word, MS Teams) and Adobe Professional.
• Excellent attention to detail.
• Ability to communicate effectively and to work with individuals of all levels.
• Holds a valid driver’s license.
• US Citizenship required and the ability to obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Lifting: Requires lifting materials up to 25 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

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

Compensation

• The annual salary range for this position is $61,000-$79,200. 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.