Clinical Research Data and Analytics Manager (Hybrid) The Geneva FoundationClinical Research Data and Analytics Manager (Hybrid)Bethesda, MarylandReporting to the Senior Manager of Regulatory Affairs & Data, this role directly oversees a small, dedicated team (including a Clinical Data Manager and a Data Management Analyst) supporting a robust portfolio of 65+ active multi-site research studies, including federally funded, FDA-regulated and industry-sponsored clinical trials, across military treatment facilities, academic institutions, and other sites nationwide. Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness.
Clinical Research Associate II- Government Sector Emmes GroupClinical Research Associate II- Government SectorRockvilleRemoteFull timeAs part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.
Clinical Research Coordinator II - Oncology MedStar Health Research InstituteClinical Research Coordinator II - OncologyWashington, DC$59,820–$101,836 / yearReceives and maintains test articles from sponsor and inventory test articles; works with research pharmacist as applicable; stores test article supplies according to Food and Drug Administration (FDA) regulations and sponsor requirements; administers test article as appropriate; Retrieves test articles and calculates research participant compliance; maintains randomization and emergency codes of test article; documents on accountability log and research participant record (e.g. Acts as a liaison with research participants investigators sponsors and healthcare professionals; prepares for site qualification study initiation monitoring and close-out visits; Ensures all research participant encounters are updated as appropriate and within one business day in clinical trial management system (CTMS); works effectively with multidisciplinary ancillary and inter-professional research teams; possesses a basic understanding of scientific center goals and the importance of serving our customers.
Clinical Research Manager The Geneva FoundationClinical Research ManagerBethesda, MarylandMaintain and update files of all applicable regulatory documentation for IRB (including protocols, approvals, amendments, modifications, etc.) as well as internal study documents (logs, manual of procedures, etc.), and any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.). Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports, etc.
NewClinical Research Coordinator III - Cardiology MedStar HealthClinical Research Coordinator III - CardiologyWashington, DC$65,062–$117,291 / yearFull timeSupports an investigator-initiated IND or IDE study; prepares for internal or external audits and/or FDA inspections; assists and facilitates research and/or project team meetings; coordinates multi-center studies as applicable; acts as a liaison for research participants investigators sponsors and healthcare professionals and compose clear precise and detailed correspondence; schedules and leads site qualification study initiation monitoring and close-out visits; Ensures that all key personnel engaged in the research project have met training requirements in accordance with Federal regulations institution and sponsor policies and procedures; maintains effective and ongoing communication with sponsor multidisciplinary ancillary and inter-professional research teams; understands and contributes to scientific center goals and growth and maintains knowledge in the field through attending related project meetings reading related literature and maintains professional associations as appropriate. Works with study team as needed to define biospecimen collection processing and storage procedures; trains others as needed to collect and label samples as instructed and delivers or processes samples in accordance with protocol; communicates with manager investigator and sponsor regarding laboratory findings and recognizes common laboratory values and alerts; maintains current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens and International Air Transportation Association (IATA) training for routine packing labeling and transporting of biological materials.
Sr. Clinical Research Associate Emmes GroupSr. Clinical Research AssociateRockvilleFull timeAs part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
NewClinical Research Nurse II/Sonographer IREClinical Research Nurse II/SonographerUs, WashingtonMinimum of 2-3 years of clinical nursing experience, preferably in a research or academic healthcare setting, with demonstrated knowledge of clinical trial operations, GCP guidelines, and regulatory requirements governing human subjects research. Collecting, recording, and analyzing clinical data, including vital signs, laboratory results, and adverse events, in electronic case report forms (eCRFs) and study databases.
NewClinical Research Supervisor (GU) University of ColoradoClinical Research Supervisor (GU)Washington, DC$67,511–$85,874 / yearJob Summary: As an important member of the research team, the Clinical Research Supervisor will report to the team manager This position works with Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. It is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs.
Clinical Research Associate I Emmes GroupClinical Research Associate IRockvilleRemoteFull timeAs part of the site visits, conducts Informed Consent ICF review, source data verification/source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under direction from the project CRA staff oversight lead. Responsibilities: Under the supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., conducts remote and on site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.
Lead Research Associate - Clinical Data Manager (REDCap) WestatLead Research Associate - Clinical Data Manager (REDCap)Bethesda, MD$82,000–$109,000 / yearA strong understanding of electronic Case Report Forms (eCRFs), surveys, and clinical databases (EDC, ePRO, eConsent) for clinical trial and clinical intervention study protocols and the ability to work with scientific protocol lead staff and systems developers is required. Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history.
Clinical Research Coordinator II - TraCR The Henry M Jackson Foundation for the Advancement of Military Medicine IncClinical Research Coordinator II - TraCRBethesda, MDWithin the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials. Assists human subjects' research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the NMRC CTC in conjunction with senior staff.
Clinical Research Coordinator I CBH Health LLCClinical Research Coordinator IGaithersburg, MD$26.90–$34.35 / hourPart timeRecently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Clinical Research Associate (CRA) - Oncology (Remote) Merck & Co IncClinical Research Associate (CRA) - Oncology (Remote)Maryland, MDRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
In-House Clinical Research Associate Zp Group LlcIn-House Clinical Research AssociateBethesda, MD$50,000–$80,000 / yearKeywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook. Responsibilities of the In-House Clinical Research Associate include: Review and process essential regulatory documents received from clinical trial sites.
Clinical Program Manager Guidehouse IncClinical Program ManagerBethesda, MD$85,000–$141,000 / yearWhat You Will Do: We are currently searching for a Clinical Program Manger to support complex clinical research programs by coordinating investigators, research teams, oversight offices, regulatory agencies, partner institutions, and other key stakeholders to ensure studies run efficiently. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
Clinical Research Coordinator (PRN) Trinity HealthClinical Research Coordinator (PRN)Silver Spring, MD$27.75–$44 / hourHoly Cross Hospital, in Silver Spring, is one of the largest hospitals in Maryland, and Holy Cross Germantown Hospital is the first hospital in the nation built on a community college campus, enhanced by an educational partnership. Position Purpose: The Clinical Research Coordinator coordinates pharmaceutical company, National Cancer Institute (NCI), multisite and in-house protocol activities for the Cancer Program and principal investigators.
Senior Clinical Research Associate - CNS - Southeast/MidAtlantic (Remote) Worldwide Clinical Trials Holdings IncSenior Clinical Research Associate - CNS - Southeast/MidAtlantic (Remote)MDRemote$97,000–$193,000 / yearTypically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
Senior Clinical Research Associate - Rare CNS - Southeast/Mid-Atlantic (Remote) Worldwide Clinical Trials Holdings IncSenior Clinical Research Associate - Rare CNS - Southeast/Mid-Atlantic (Remote)MDRemote$97,000–$193,000 / yearTypically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
Clinical Research Coordinator (52062) Gap Solutions, Inc.Clinical Research Coordinator (52062)Bethesda, MDWork products and documents related to the scoring and processing of neurocognitive testing of research participants; assist in the planning, administration and coding of the protocol's focus group studies; develop, maintain, and generate reports for an academic level database for tracking recruitment and recruitment outcomes for the protocols - Ad-Hoc. Work products and documents related to compiling and consolidating weekly schedules for patients; ensure appropriate distribution; perform management of travel and reimbursement-related aspects of protocol submission and renewal; perform administration of qualitative interviews to research participants.
NewNurse (Clinical Research) US Department of Health and Human ServicesNurse (Clinical Research)Washington, DC$85,532–$120,051 / yearIn addition, to qualify for a Nurse (Clinical Research) position at the GS-11 level, you must have at least 1 year of professional Nurse experience equivalent to at least the GS-09 level in the federal service obtained in either the private or public sector, performing the following types of tasks: 1.) Providing comprehensive nursing care to patients based on the physicians medical care plan and the physical, mental and emotional needs of the patient 2.) Administering oxygen, IV fluid, blood transfusions and prescribed oral, subcutaneous and intramuscular medications. This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.