CAMRIS
Clinical Research Coordinator I
CAMRIS, San Diego, California, United States, 92189
Overview
We are seeking a
Clinical Research Coordinator I
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. CAMRIS International, LLC, is a dynamic medical research and development firm that combines 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. Responsibilities Primary Responsibilities Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. 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. Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies procedures to align with the objectives of clinical trials. Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards. Regulatory Management Assists with Institutional Review Board (IRB) submissions and protocol amendments. Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. Ensures all study-related documents are appropriately filed and accessible for audits. Other Responsibilities May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. 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. Qualifications Required A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. 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, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Employment is contingent upon successful completion of a Public Trust-level background check.
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Clinical Research Coordinator I
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. CAMRIS International, LLC, is a dynamic medical research and development firm that combines 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. Responsibilities Primary Responsibilities Patient Recruitment and Consent: Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines. 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. Study Protocol Design and Oversight: Interprets study protocols, assesses feasibility, and modifies procedures to align with the objectives of clinical trials. Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures. Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS). Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings. Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines. Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards. Regulatory Management Assists with Institutional Review Board (IRB) submissions and protocol amendments. Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle. Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements. Ensures all study-related documents are appropriately filed and accessible for audits. Other Responsibilities May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel. 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. Qualifications Required A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of clinical research experience. Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes. Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems. Strong organizational, communication, and problem-solving skills. Ability to work both independently and collaboratively in a research setting. US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred Certification in clinical research (such as CCRC or CCRP). Experience with infectious disease studies or military health research. 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, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Employment is contingent upon successful completion of a Public Trust-level background check.
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