Clinical Project Manager (Quality Systems)
Nextonic Solutions LLC
Clinical Project Manager (Quality Systems) Bethesda, United States | Posted on 01/09/2026 Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Project Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), Office of Clinical Research Affairs (OCRA). Responsibilities Provide quality management support for Division clinical research activities. Support the development, implementation, maintenance, and oversight of a clinical quality management system in NIAID – inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities. Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents. Support the development and implementation of the Division’s electronic Quality Management System (eQMS). Stay current with changes to current industry standards and applicable regulations for quality in clinical research. Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPA's for internal & external audits. Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events. Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies. Review, track and/or trend routine quality data. Report adverse trends to management with proposed remediation plan. Coordinate the development of various QA related metric reports. Work with other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID. Based on understanding of Division Operations, look for ways to standardize processes in-order to improve quality and/or facilitate efficiency. Qualifications Bachelor’s degree in a related discipline. Minimum of five (5) years of experience in clinical research or a related field. Experience in establishing and managing quality management systems for clinical research for IND sponsors (e.g. in pharmaceutical companies, biotechnology companies, or government sponsors). Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes. Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment. Knowledge of electronic clinical quality management systems such as Master Control is preferred. Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred. Experience conducting or overseeing audits is preferred. Experience working at a clinical research site is preferred. Experience in the NIH or other government agency is preferred. Excellent communication skills both verbally and written; and across functions internally and external. Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables. Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in-order to effectively solve problems. Excellent multi-tasking, analytical, organizational and teamwork skills. Ability to troubleshoot, identify root cause and systematically resolve problems. Ability to produce high-quality work on complex problems with cross-functional involvement. Proficient in Window based software to include Excel, Word. #J-18808-Ljbffr Nextonic Solutions LLC
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- ...Description: Job Title: Clinical Research Coordinator Employment... ...clinical research and project management experience. -Ability to communicate... ..., not-for-profit health system that serves the two most... ...Holy Cross Health's high-quality and coordinated continuum of...SuggestedHourly payPart timeReliefLocal areaFlexible hoursShift workDay shift
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...software engineering, and program management, we focus on developing and... ...(NIH). Axle is seeking a Clinical Research Coordinator to join... ...with clinical trial management systems and research databases,... ...portfolios Develop and maintain project management plans for clinical...Contract workFor contractorsWork at officeLocal areaFlexible hours$100k - $110k
...Objective: Provide services as a Clinical Research Coordinator in... ...records, hospital information system and laboratory information system... ...in coordination and management of most daily activities of the... ...Experienced in coordinating project meetings, electronic medical...Full timeWork at officeLocal areaShift work- Dovel Technologies, Inc. is seeking a Clinical Research Coordinator to support oncology trials at the National... ...informed consent, collect data, and maintain high-quality source documentation within EMR/CTMS/EDC systems while complying with FDA, ICH-GCP, and human subjects...Full time
- Senior Director, Quality Management System (QMS) Venture Global LNG (“Venture Global”) is a long‑term, low‑cost provider of American‑produced... ...liquefied natural gas. The company’s Louisiana‑based export projects service the global demand for North American natural gas...
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- ...research tools and data science applications. We seek a Clinical Research Coordinator to manage complex portfolios, collaborate with investigators, and... ...FAC-P/M, FAC-COR, PMP, ACRP) and experience with CRT management systems and research databases. #J-18808-Ljbffr Axle
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...Job Description SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and... ...contributions to the company's success. The Director, Head of Quality Management System (QMS) is responsible for establishing, leading, and...Contract work$100k - $120k
Johnson Controls, Inc. is seeking a Quality Control Manager to join our federal team at the Pentagon in Arlington, VA. This position focuses... ...quality control for HVAC and Building Automation Systems projects. Key qualifications include 5+ years of relevant experience...$30 per hour
...DescriptionConcentric Methods is seeking an experienced Clinical Research Coordinator to independently... ...methods, including recruitment, entry, management and display for the Department of... ...development and review of new research projects. - Work with staff on manuscript...Hourly pay- ...pioneering new approaches to distributed systems quality. This is possibly the most complex and... ...to lead this work.As the engineering manager you'll lead the team, shaping the vision... ...containers and K8sFamiliarity and real project experience with PythonWhat is Canonical...Remote workWorldwide
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...compliance activities for complex GxP systems as a Senior Consultant,... ..., audit readiness, CAPA management, and risk-based compliance activities... ...attention to detail and quality of work productAbility to... ...relationshipsAbility to lead projects or workstreamsAbility to manage...Remote workVisa sponsorship$25 - $35 per hour
...Clinical Research Coordinator This full-time Clinical Research Coordinator role supports... ...data into electronic data capture (EDC) systems with a high degree of accuracy.... ...policies in all aspects of participant management and data handling. Essential Skills...Full timeContract workTemporary workWork at officeMonday to Friday- ...Clinical Research Coordinator II The Clinical Research... ...II conducts and manages multiple clinical trials... ...out reports. Apply project management concepts to... ...manage risk and improve quality in the conduct of a... ...sponsor/CRO data capture systems and resolving queries...Work at officeFlexible hours
$55k - $65k
...Clinical Research Coordinator I Rockville-Shady Grove - Rockville, MD 20850 Start Date... ...Facilities, and other outside vendors to manage the day-to-day needs for current and prospective... ..., and Outlook Specialty knowledge of systems relating to job function Knowledge of...Full timeContract work$44.02k - $73.41k
...Requirements Job Overview The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating 7 out of... ...trial visits via the OnCore/CTMS system Accurate and timely data... ..., the CRC II will also provide project-specific deliverables to others...Hourly payFull timeWork experience placementWork at office$17.2 - $30.3 per hour
...Clinical Research Coordinator Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new... ...study participants. Assist with setup of the data collection system and enter and organize data. Assist in coordinating study meetings...Full time$20.16 - $31.3 per hour
...Job Overview Serves as clinical research coordinator for phase... ...Assist in the assessment, management, and coordination across the... ...the Clinical Trials Management System (CTMS) with patient information... ...Annual Pay Range: The projected salary or hourly pay range for...Hourly payWork at office- ...leading IT services firm is seeking a Policy & Quality Assurance Lead responsible for ensuring... ...provide testing oversight across complex systems. The ideal candidate has over 10 years of... ...regulatory compliance and the ability to manage stakeholder relationships effectively. #J...
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