Assistant Clinical Research Coordinator
We are seeking an Assistant Clinical Research Coordinator to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. OID conducts ongoing, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations).
About the Role
In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, and, when applicable, county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health.
Responsibilities
- Manages day-to-day operations of clinical research studies, ensuring adherence to study protocols and regulatory requirements.
- Coordinates the implementation of study protocols, including preparing and submitting protocol amendments and updates.
- Works with coordinators to ensure that research studies remain on schedule and meet target milestones.
- Assist in writing and editing SOPs, presentations, protocols, agreements or other study documents as requested.
- Maintain a positive relationship with site leadership and serve as liaison between NHRC and site.
- Assist with reviews of study documents.
- Screens potential participants for eligibility according to study criteria.
- Obtains informed consent from study participants and explains study procedures in compliance with ethical standards.
- Coordinates and schedules study visits, ensuring participant adherence to study requirements.
- Collects and accurately records study data, including patient information and study outcomes.
- Collects samples per protocol, including in outbreak situations, as needed. Sample types may include wastewater and vectors, such as mosquitoes and ticks.
- Enters and manages data in the study database, ensuring data integrity and compliance with Good Clinical Practice (GCP) standards.
- Assists with resolving data queries and discrepancies, working closely with study teams to ensure data accuracy.
- Per protocol, conducts follow-up visits or calls to study participants, monitoring their progress and ensuring they remain engaged in the study.
- Reports any adverse events or changes in patient status to the appropriate study personnel.
- Maintains the clinical trial database, ensuring that all study-related data is up to date and accessible for analysis.
- Assists with generating reports and summaries of study data for review by investigators and sponsors.
- Performs other duties as assigned.
Requirements
- Completion of at least two (2) years of college, with coursework in biological sciences, public health, or related fields.
- Strong organizational skills and attention to detail.
- Ability to work independently, manage multiple tasks, and prioritize effectively.
- Excellent interpersonal and communication skills, with the ability to work with patients and clinical staff.
- Proficiency in data entry and database management.
- US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
Preferred Qualifications
- Previous experience in clinical research or healthcare settings.
- Familiarity with clinical trial protocols, data collection, and patient recruitment.
- Knowledge of regulatory requirements for clinical trials, including IRB submissions and GCP standards.
Physical Requirements
The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.
Physical Demands
- Constantly conducts sedentary work that primarily involves sitting/standing.
- Occasionally conducts light work that includes moving objects up to 20 pounds.
- Occasionally conducts medium work that includes moving objects up to 50 pounds.
- Occasionally required to push or pull less than 25 pounds.
- Occasionally required to reach above shoulder level.
- Constantly uses both hands.
- Occasionally stands or walks for more than 25 minutes.
- Occasionally bends, reaches, or twists repeatedly.
- Occasionally kneels, squats, or stoops.
- Occasionally crawls or climbs.
- Constantly required to have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
- Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
- Occasionally moves about to accomplish tasks or moves from one worksite to another.
- Constantly communicates with others to exchange information.
- Occasionally operates machinery and/or power tools.
- Occasionally operates motor vehicles or heavy equipment.
- Constantly required to assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
- Occasionally works in low temperatures.
- Occasionally works in high temperatures.
- Occasionally works in outdoor elements, such as precipitation and wind.
- Occasionally works in noisy environments.
- Occasionally works in hazardous conditions.
- Occasionally works in poor ventilation.
- Occasionally works in small and/or enclosed spaces.
- Occasionally works in environments where no adverse environmental conditions are expected.
PPE and Chemical Requirements
- Constantly wears PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
- Constantly wears a lab coat.
- Occasionally wears a disposable dust/surgical mask.
- Occasionally uses respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
- Occasionally comes in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust and powders, etc.
Benefits
- Medical, dental, and vision insurance for individuals and families.
- FSAs and HSA options.
- Life and AD&D insurance.
- Short- and long-term disability.
- Legal services.
- Voluntary hospital indemnity, critical illness, and accident insurances.
- EAP (Employee Assistance Program).
- Pet insurance.
- 401(k) with employer match and Roth option.
- Tuition and professional reimbursement.
- Public transportation support in the DMV area.
- Referral bonus program.
- Vacation with tenure-based increases.
- PTO (Paid Time Off).
- 11 paid holidays.
- Paid bonding leave.
- Paid supplemental short-term disability.
Employment is contingent upon successful completion of a secret-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to: contacting professional references, verification of previous employment, education and credentials, a criminal background check, use/abuse of federally-controlled substances, and a department of motor vehicle check.