Clinical Research Coordinator II

CAMRIS seeks a Clinical Research Coordinator II to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate by overseeing and administering research studies and ensuring compliance with study protocols and regulatory requirements. The role involves assisting with project planning, recruiting and coordinating research subjects, and serving as the primary administrative liaison for projects. The Clinical Research Coordinator II oversees staff services, maintains record-keeping systems, and ensures seamless study operations. This position provides an exciting opportunity to lead critical research initiatives in infectious diseases, supporting military health and global public health efforts. The Clinical Research Coordinator II will help ensure the success of clinical trials and research projects at NHRC.

The OID Directorate 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). 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

Study Administration and Oversight

• Oversee research studies and associated activities to ensure adherence to study protocols, timelines, and regulatory standards.
• Monitor study progress and assist in project planning to meet study milestones and objectives.
• Ensure pre-established work scope and study protocols are followed throughout the study lifecycle.

Regulatory Compliance

• Ensure all activities comply with Institutional Review Board (IRB) requirements and other regulatory standards.
• Prepare, obtain, and track agreements and approvals.
• Prepare and submit IRB applications, amendments, and continuing reviews.
• Maintain accurate study documentation and ensure that study protocols are adhered to throughout the study lifecycle.
• Prepare for and participate in monitoring visits, audits, and inspections by regulatory agencies.

Participant Recruitment and Coordination

• Recruit, screen, and coordinate research subjects as per study protocols.
• Obtain informed consent and schedule subject visits, ensuring compliance with study requirements.

Liaison and Communication

• Serve as the primary administrative point of contact between investigators, research staff, and external stakeholders.
• Facilitate communication between clinical teams, sponsors, and regulatory authorities to ensure smooth study execution.

Administration and Staff Services

• Serve as an administrative point of contact between investigators, research staff, and external stakeholders.
• Facilitate communication between clinical teams, sponsors, and regulatory authorities to ensure smooth study execution.

Sample Collection, Data Management, and Reporting

• Collect samples per protocol.
• Supervise data collection and entry to ensure accuracy and completeness.
• Address data queries and resolve discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
• Prepare regular progress reports and assist with study-related presentations.

Qualifications

Required

• A BA/BS in biological sciences, public health, or equivalent PLUS one to two years of clinical research and management experience OR 8+ years of clinical trials research experience, including two years of clinical research management experience.
• Demonstrated experience with Python or RStudio.
• Strong understanding of, and familiarity with, regulatory requirements for clinical trials, including IRB submissions and reporting processes.
• Strong understanding of clinical research principles, study design, and regulatory requirements.
• Familiarity with Clinical Trial Management Systems (CTMS) and electronic IRB (eIRB) systems.
• Excellent organizational, communication, and leadership skills.
• Strong organizational, communication, and problem-solving skills.
• Ability to work both independently and collaboratively in a research setting.
• Ability to manage multiple projects and prioritize tasks in a dynamic research environment.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Preferred

• Certification in clinical research (such as CCRC or CCRP).
• Tableau and Power BI experience is desired.
• Experience with infectious disease studies or military health research.
• Proven experience in project management or supervisory roles within clinical research.

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical 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 conduct sedentary work that primarily involves sitting/standing.
• Occasionally conduct light work that includes moving objects up to 20 pounds.
• Occasionally conduct medium work that includes moving objects up to 50 pounds.
• Occasionally push or pull less than 25 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Occasionally bend, reach, or twist repeatedly.
• Occasionally kneel, squat, or stoop.
• Occasionally crawl or climb.
• Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.

Physical Activities

• Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
• Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy, neatness, and thoroughness of the work assigned.

Environmental Conditions

• Occasional work in low temperatures.
• Occasional work in high temperatures.
• Occasional work in outdoor elements, such as precipitation and wind.
• Occasional work in noisy environments.
• Occasional work in small and/or enclosed spaces.
• Occasional work in environments where no adverse environmental conditions are expected.

PPE and Chemical Requirements

• Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
• Occasionally wear a lab coat.
• Occasionally wear a disposable dust/surgical mask.
• Occasionally wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, political affiliation, marital status, military status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and 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 the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.