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Research Associate
1 week ago
Meso Scale Diagnostics, LLC. Gaithersburg, United States: · This position is responsible for executing experiments and analyzing the resulting data in support of reagent and assay development projects with close supervision. This is a laboratory-based position responsible for advancing research and/or development objectives focused on ...
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Research Associate Ii
1 week ago
Novavax Gaithersburg, United StatesIf you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. · Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas Together we use our un ...
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Research Associate
1 week ago
Celnovte Biotechnology, Inc. Rockville, United States**Research Associate - Immunoassay and Bioconjugation** · **Responsibility** · 50% Production Support · Performing quality control assays and protein conjugation reactions in scale-up production of bioconjugates utilizing Standard Operating Procedures (SOP), Batch Records and For ...
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Research Associate
2 weeks ago
Actalent Rockville, United States Full timeDescription: · Our client is looking for a Research Associate to join their Immunoassay team and work in developing and performing immunoassays that provide high quality products and services to clients as we partner with them to produce innovative ways to improve global health. ...
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Research Associate
2 weeks ago
Celnovte Biotechnology, Inc. Rockville, United States**Research Associate - Immunoassay and Bioconjugation** · **Responsibility** · 50% Production Support · Performing quality control assays and protein conjugation reactions in scale-up production of bioconjugates utilizing Standard Operating Procedures (SOP), Batch Records and For ...
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Research Associate
3 weeks ago
Synergy Enterprises, Inc. Rockville, United States**Company Description** · Synergy Enterprises, Inc., a minority, and woman-owned government contractor located in North Bethesda, MD. · **Job Description** Job Summary**: · Synergy Enterprises, Inc., a minority, and woman-owned government contractor located in North Bethesda, MD, ...
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Clinical Research Associate
1 week ago
Cartesian Therapeutics Gaithersburg, United States**Summary**: · **Principal **Duties/Responsibilities**: · - Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; · - Communication with the medical site staff including coordinators, clinical research physi ...
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Research Associate Ii
4 days ago
Novavax Gaithersburg, United StatesIf you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. · Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas Together we use our un ...
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Research Associate
1 week ago
Actalent Rockville, United States Full timeDescription: · The primary role of the position will be to perform routine testing for development samples using analytical chemistry methods. These methods could include spectrophotometry, capillary gel electrophoresis, HPLC, and dynamic light scattering, and this role includes ...
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Research Associate
2 weeks ago
Actalent Rockville, United States Full timeDescription: · Describe in just a few sentences the day-to-day activity of the role. · The primary role of the position will be to perform routine testing for development samples using analytical chemistry methods. These methods could include spectrophotometry, capillary gel ele ...
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Research Associate
1 week ago
Actalent Rockville, United States Full timeDescription: · Describe in just a few sentences the day-to-day activity of the role. · The primary role of the position will be to perform routine testing for development samples using analytical chemistry methods. These methods could include spectrophotometry, capillary gel ele ...
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Research Associate
1 week ago
Actalent Rockville, United States Full timeDescription: · The primary role of the position will be to perform routine testing for development samples using analytical chemistry methods. These methods could include spectrophotometry, capillary gel electrophoresis, HPLC, and dynamic light scattering, and this role includes ...
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Principal Research Associate
3 weeks ago
WESTAT Rockville, United StatesWestat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in ...
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Principal Research Associate
3 days ago
WESTAT Rockville, United StatesWestat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in ...
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Research Associate Ii
1 day ago
Bioqual Inc Rockville, United States**OBJECTIVE**: · The Research Associate II position is responsible for performing immunological assays in support of scientific investigations. This laboratory-based position responsible for conducting in vitro experiments in order to produce reliable and precise data. RA II shou ...
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Principal Research Associate
1 week ago
WESTAT Rockville, United StatesWestat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in ...
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Research Associate
2 weeks ago
Georgetown University Washington, United StatesLocated in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals i ...
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Research Associate
2 weeks ago
Georgetown University Washington, United States Part timeLocated in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals i ...
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Research Associate
1 week ago
The Henry M. Jackson Foundation for the Advancement of Military Medicine Frederick, United StatesOverview: · **Join the HJF Team** · This position will be in support of the **United States Army Medical Research Institute of Infectious Diseases (USAMRIID)**. This position will support research programs focused on the development of medical countermeasures (therapeutics and va ...
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Research Associate I, Cell Culture
3 weeks ago
Champions Oncology Inc. Rockville, United States**TITLE AND CLASSIFICATION**: Research Associate I, Cell Culture · **REPORTING LOCATION**: Rockville, MD · The primary objective of the Research Associate I, Cell Culture is to perform cross-functional laboratory assays with a focus on in vitro/ex-vivo in support of in vivo studi ...
Clinical Research Associate - Gaithersburg, United States - Cartesian Therapeutics
Description
SummaryWe are seeking a highly skilled and experienced Clinical Research Associate (CRA) with a strong background in Phase I-III clinical trials, particularly in the Autoimmune therapeutic area, with desired expertise in Cell & Gene Therapy.
The ideal candidate will be responsible for monitoring and managing clinical trial activities, ensuring compliance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
This role requires meticulous attention to detail, excellent communication skills, and the ability to work effectively within a multidisciplinary team environment.
Principal
Duties/Responsibilities
:
Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
Verification that the investigator is enrolling only eligible subjects;
Regulatory document review;
Investigational product/drug accountability and inventory;
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
:
Bachelor's degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
Minimum of 6 years of experience as a Clinical Research Associate, with significant experience in
Phase I-III
clinical trials within the Autoimmune therapeutic area.
Demonstrated expertise in Cell & Gene Therapy trials is highly desired.
Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements.
Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment.
Excellent interpersonal, communication, and organizational skills.
Ability to travel domestically and internationally, as required, up to 50%.
Certification as a Clinical Research Professional (CCRP) or equivalent is a plus.
Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems.
Work
Environment
:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments.
An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention.
Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory.The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat.
Position may require extended periods of standing.#J-18808-Ljbffr