Overview:
We are seeking a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate.
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.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities:
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Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines.
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Help lead recruitment efforts, developing and refining strategies to meet enrollment targets.
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Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria.
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Manage and coordinate complex clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study.
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Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifies procedures to align with the objectives of clinical trials.
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Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures.
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Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS).
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Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings.
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Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
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Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager.
Regulatory Management
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Assists with Institutional Review Board (IRB) submissions and protocol amendments.
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Collaborate with principal investigators and sponsors and provide insights based on field experience.
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Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities.
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Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system.
Compliance and Monitoring
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Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle.
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Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise.
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Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes.
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Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies.
Regulatory Responsibilities
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Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements.
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Ensures all study-related documents are appropriately filed and accessible for audits.
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Manages study registrations and updates in the Clinical Trial Management System and eIRB system.
Other Responsibilities
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May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
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Remote and On-Site Study Leadership:
- Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel.
- Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site.
- Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety.
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Performs other duties as assigned.
Qualifications:
Required
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A BA/BS in biological sciences, public health, or a related field OR five (5) plus years of clinical research experience.
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Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes.
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Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems.
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Strong organizational, communication, and problem-solving skills.
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Ability to work both independently and collaboratively in a research setting.
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US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
Preferred
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Certification in clinical research (such as CCRC or CCRP).
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Experience with infectious disease studies or military health 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
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Constantly conduct sedentary work that primarily involves sitting/standing.
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Occasionally conduct light work that includes moving objects up to 20 pounds.
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Occasionally conduct medium work that includes moving objects up to 50 pounds.
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Occasionally push or pull less than 25 pounds, push or pull 25 – 45 pounds, or push or pull more than 45 pounds.
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Occasionally reach above shoulder level.
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Constantly use both hands.
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Occasionally stand or walk for more than 25 minutes.
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Occasionally bend, reach, or twist repeatedly.
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Occasionally kneel, squat, or stoop.
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Occasionally crawl or climb.
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Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity.
Physical Activities
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Occasionally ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like.
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Occasionally move self in different positions to accomplish tasks in various environments, including tight and confined spaces.
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Occasionally move about to accomplish tasks or move from one worksite to another.
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Constantly communicate with others to exchange information.
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Occasionally operate motor vehicles or heavy equipment.
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Constantly assess the accuracy, neatness, and thoroughness of the work assigned.
Environmental Conditions
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Occasional work in low temperatures.
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Occasional work in high temperatures.
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Occasional work in outdoor elements, such as precipitation and wind.
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Occasional work in noisy environments.
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Occasional work in small and/or enclosed spaces.
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Occasional work in environments where no adverse environmental conditions are expected.
PPE and Chemical Requirements
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Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes.
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Occasionally wear a lab coat.
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Occasionally wear a disposable dust/surgical mask.
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Occasionally wear respirators, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA.
Please submit your resume online at www.CAMRIS.com. 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.
