Clinical Research Coordinator I - SPA

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator I to perform clinical research and patient treatment 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 assure that protocol requirements are achieved within Good Clinical Practices.

This position will be in support of USU Department of Medicine Translational Medicine Unit, located in Bethesda MD. This Phase I study conducted at the Uniformed Services University Translational Medicine Unit, is a randomized, placebo-controlled, double-blind, 4-period crossover study comparing LT-120, an intranasal esketamine nasal spray, with intravenous racemic ketamine under fasted conditions. The primary goal is to compare the bioavailability of intranasal esketamine with IV ketamine, while the secondary goal is to assess the relative analgesic, or antinociceptive, effects of LT-120 using thermal pain testing.

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.

• Support participant screening, eligibility verification, and enrollment activities in accordance with study protocol requirements.
• Coordinate and manage participant visits, including admission, scheduling, confinement logistics, and follow-up activities.
• Ensure accurate execution and timing of protocol-required procedures, including pharmacokinetic (PK), pharmacodynamic (PD), and safety assessments.
• Coordinate and monitor collection of protocol-specific study samples, including timed blood draws and specimen tracking.
• Conduct and document safety assessments, including vital signs, pulse oximetry, adverse event collection, concomitant medication review, and participant monitoring.
• Administer and support study-related assessments and questionnaires, including sedation, dissociation, euphoria, and thermal stimulation evaluations.
• Maintain complete and accurate source documentation and case report forms (CRFs) in compliance with study and regulatory requirements.
• Monitor visit flow and protocol adherence to ensure timely completion of study procedures and prevent protocol deviations.
• Perform participant follow-up activities and communicate study-related concerns to the clinical and research team.
• Support overall study coordination activities to ensure quality, regulatory compliance, and successful study execution.
• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practices.
• 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 required.
• Minimum of 0-2 years experience required.

Required Knowledge, Skills and Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
• Excellent interpersonal and computer skills.
• Ability to communicate effectively and to work with individuals of all levels.
• Ability to obtain and maintain a T1/Public Trust background check.

Work Environment

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

Compensation

The annual salary range for this position is $46,100-$70,000. 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.