Clinical Research Quality Manager

2 months ago

Rockville, United States Kelly Full time

Kelly Government Solutions is seeking an experienced individual to work as a Clinical Research Quality Manager at the National Institutes of Health in Rockville, MD. Position is estimated to support a hybrid work arrangement that is primarily remote with occasional on-site work (1-2 days/month) at the NIH in Rockville, MD.


TASKS

(1) Provide quality management support for NIAID Division of Microbiology and Infectious Diseases (DMID) clinical research activities.

(2) Support the development, implementation, maintenance, and oversite of a clinical quality management system at NIAID including document management, issue management, CAPA development, and quality assurance (QA) activities.

(3) 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.

(4) Support the development and implementation of the Division’s electronic Quality Management System (eQMS).

(5) Stay current with changes to current industry standards and applicable regulations for quality in clinical research.

(6) 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 CAPAs for internal and external audits.

(7) Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.

(8) Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities, provide assessment of the impact of any deficiencies, and identify ways to standardized processes to improve quality and/or facilitate efficiency

(9) Review, track and/or trend routine quality data; coordinate the development of QA-related metric reports.

(10) Report adverse trends to management with proposed remediation plan.


REQUIREMENTS

(1) Bachelor’s degree in a related discipline.

(2) Minimum of five (5) years of experience in clinical research including work at a research site and/or government agency

(3) Experience establishing and managing quality management systems for clinical research for IND sponsors (e.g., in pharmaceutical companies, biotechnology companies, or government sponsors).

(4) Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes; knowledge of electronic clinical quality management systems such as Master Control preferred

(5) Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.

(6) Experience conducting or overseeing audits and/or regulatory inspections from the US FDA or similar government regulatory authorities preferred.

(7) Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical vendors/CROs) to effectively troubleshoot and solve problems

  • Clinical Research Quality Manager

    2 months ago

    Rockville, United States Kelly Full time

    Kelly Government Solutions is seeking an experienced individual to work as a Clinical Research Quality Manager at the National Institutes of Health in Rockville, MD. Position is estimated to support a hybrid work arrangement that is primarily remote with occasional on-site work (1-2 days/month) at the NIH in Rockville, MD. TASKS(1) Provide quality management...

  • Clinical Research Coordinator

    2 days ago

    Rockville, United States PriceSenz Full time

    Job DescriptionJob DescriptionJob Title: Clinical Research CoordinatorLocation: Rockville, MDEducation: Bachelor's degree requiredCertifications: Clinical Research Coordinator (CRC)We are looking for a Clinical Research Coordinator to provide comprehensive support services for ongoing research projects in the medical field. The role involves assisting...

  • Clinical Research Coordinator

    2 days ago

    Rockville, United States LMR Technical Group Full time

    Job DescriptionJob DescriptionSalary: LMR Technical Group (LMR) is seeking a Clinical Research Coordinator.Location: Rockville, MD. Teleworking eligible.Job Description: The Clinical Research Coordinator will independently provide support services to satisfy the overall operational objectives of the National Cancer Institute, Division of Cancer Epidemiology...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Rockville, Maryland, United States PriceSenz Full time

    Job OverviewPosition: Clinical Protocol CoordinatorLocation: PriceSenzWeekly Hours: Full-Time: 30-40 hours per weekPosition Summary:The Clinical Protocol Coordinator will play a pivotal role in supporting clinical and biospecimen research initiatives at PriceSenz. This position requires a detail-oriented and organized individual with excellent communication...

  • Clinical Research Protocol Specialist

    2 weeks ago

    Rockville, Maryland, United States PriceSenz Full time

    Job OverviewPosition Title: Clinical Protocol CoordinatorCompany: PriceSenzLocation: Rockville, MDWeekly Commitment: Full-Time, 30-40 hours per weekPosition Summary:The Clinical Protocol Coordinator will play a vital role in the Translational Immunopsychiatry Unit (TIU) at PriceSenz. This position is ideal for a dedicated, detail-oriented individual with...

  • Clinical Research Specialist

    2 weeks ago

    Rockville, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustRole Overview:We are seeking a Clinical Research Specialist to provide essential support services that align with the operational goals of the National Institute of Mental Health (NIMH). This position is a full-time opportunity.In this role, you...

  • Vice President of Clinical Research Operations

    2 weeks ago

    Rockville, Maryland, United States Westat, Inc. Full time

    Position Overview:Westat, Inc. is a leading employee-owned organization that provides research services to various sectors, including federal agencies, businesses, and local governments. We are dedicated to fostering a diverse workforce and promoting a culture of inclusivity, belonging, and equity.Role Summary:We are seeking a highly skilled and motivated...

  • Clinical Research Specialist

    2 weeks ago

    Rockville, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Requirements:No travel expectedSecurity Clearance:Ability to Obtain Public TrustKey Responsibilities:We are seeking a Clinical Research Advisor to provide independent support services aimed at achieving the operational goals of the National Institute of Mental Health (NIMH). This is a full-time role....

  • Research Associate III

    2 weeks ago

    Rockville, United States Frederick National Laboratory for Cancer Research Full time

    Research Associate III Job ID: req4067Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: Generic LocationLocation: 9800 Medical Center Drive, Rockville, MD 20850 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...

  • Clinical Research Advisor

    3 weeks ago

    Rockville, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do: We are currently searching for a Clinical Research Advisor. This role will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH) . This is a...

  • Clinical Research Advisor

    4 weeks ago

    ROCKVILLE, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do:We are currently searching for a Clinical Research Advisor. This role will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH). This is a...

  • Clinical Research Specialist

    2 weeks ago

    Rockville, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Requirements:No travel requiredClearance Requirements:Ability to Obtain Public TrustPosition Overview:We are seeking a Clinical Research Advisor to provide independent support services that align with the operational goals of the National Institute of Mental Health (NIMH). This is a full-time role....

  • Clinical Research Specialist

    2 weeks ago

    Rockville, Maryland, United States Guidehouse Full time

    Job Family:Clinical Trial Operations (Digital)Travel Requirements:No travel requiredSecurity Clearance:Ability to Obtain Public TrustPosition Overview:We are seeking a Clinical Research Advisor to provide independent support services aimed at achieving the operational goals of the National Institute of Mental Health (NIMH). This is a full-time role....

  • Researcher

    3 months ago

    Rockville, United States The American Institutes for Research Full time

    Overview Join AIR as a Researcher with our team. The mission of our team of experts is to provide statistical evidence that is meaningful, timely, accurate, and trustworthy in support of AIR’s mission. Our Education Statistics portfolio focuses on the development, collection, analysis, and communication of international, national, and state...

  • Vice President of Clinical Research Operations

    2 weeks ago

    Rockville, Maryland, United States Westat, Inc. Full time

    Position Overview:Westat, Inc. is a leading employee-owned organization dedicated to providing research services to various sectors, including U.S. Government agencies, businesses, and foundations. Our headquarters is located in Rockville, Maryland, and we pride ourselves on fostering a diverse and inclusive workforce that values equity and belonging.Role...

  • Research Scientist

    6 days ago

    Rockville, Maryland, United States The American Institutes for Research Full time

    About the PositionThe American Institutes for Research (AIR) is seeking a highly skilled Researcher to join our team of experts in education statistics. As a Researcher, you will play a critical role in providing statistical evidence that is meaningful, timely, accurate, and trustworthy in support of AIR's mission.Key ResponsibilitiesContribute to the...

  • Research Scientist

    3 days ago

    Rockville, Maryland, United States The American Institutes for Research Full time

    About the PositionThe American Institutes for Research (AIR) is seeking a highly skilled Researcher to join our team of experts in the field of education statistics. As a Researcher, you will play a critical role in providing statistical evidence that is meaningful, timely, accurate, and trustworthy in support of AIR's mission.Key ResponsibilitiesContribute...

  • Vice President of Clinical Research Operations

    2 weeks ago

    Rockville, Maryland, United States Westat, Inc. Full time

    Position Overview:Westat, Inc. is a distinguished employee-owned organization delivering research solutions to various sectors, including federal agencies, businesses, and local governments. With a dedicated workforce of over 2,000 professionals based in Rockville, Maryland, Westat is devoted to cultivating a diverse and inclusive workplace that values...

  • Research Associate III

    1 week ago

    Rockville, United States Frederick National Laboratory for Cancer Research Full time

    Research Associate III - Virology Job ID: req4067Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: Generic LocationLocation: 9800 Medical Center Drive, Rockville, MD 20850 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and...

  • Associate Director, Clinical Operations Lead

    22 hours ago

    Rockville, Maryland, United States Delricht Research Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director, Clinical Operations to join our team at DelRicht Research. This is a key leadership role that will be responsible for developing and managing a high-performing team of clinical operations professionals.Key ResponsibilitiesTeam Development: Develop and implement strategies to...