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.
Clinical Research Coordinator Children's National HospitalClinical Research CoordinatorWashington, DCIndependently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
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.
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 Associate II Emmes GroupClinical Research Associate IIRockvilleRemoteFull 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.
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.
Clinical Research Financial Coordinator II - Cardiology Washington University in St LouisClinical Research Financial Coordinator II - CardiologyWashingtonWhen necessary, works with other departments to set up services for clinical trial patients procedures performed in accordance with the protocol and is responsible for establishing a workflow to ensure study plans are in place to assist the study coordinators in completing study procedures and to ensure that supporting departments’ charges for study service are appropriately captured and billed to the study. Provides oversight, and training for clinical research financial billing coordinators who perform a review of new protocols, protocol amendments and Investigators initiated concept studies to establish and negotiate budgets for clinical trials.
Clinical Research Coordinator (PRN) Trinity HealthClinical Research Coordinator (PRN)Silver Spring, Maryland$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 - 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.
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 Coordinator The Geneva FoundationSenior Clinical Research CoordinatorBethesda, Maryland$85,000–$110,000 / yearMaintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc. Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
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.
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 Nurse Coordinator I MedStar Health Research InstituteClinical Research Nurse Coordinator IMcLean, VA$89,065–$162,801 / yearReceives and inventories test articles (study device or drug); works with research pharmacist as applicable; stores test articles according to Food and Drug Administration (FDA) regulations and Sponsor requirements; with oversight administers test articles; retrieves test articles and calculates research participant compliance as applicable; reconciles accountability log and completes research participant record. Understands and complies with rules for billing Medicare Medicaid and third-party payors for services drugs devices tests and procedures rendered in the clinical research context; responsible for following the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies; ensures research participant stipend information is submitted.
NewClinical Research Coordinator II Velocity Clinical Research IncClinical Research Coordinator IIRockville, MDImplement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports. Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.
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.
NewClinical Research & Development Associate Director AstraZeneca PlcClinical Research & Development Associate DirectorGaithersburg, MDPhD, or equivalent) in a scientific, medical, or health-related discipline; Comprehensive knowledge of the drug development process; Demonstrated knowledge of AstraZeneca line and project management tools and processes; Good understanding of the therapeutic areas related to AZ products; Ability to understand integrated worldwide and regional delivery needs; Very good knowledge of oral and written communication in English; Ability to travel nationally and internationally. Internal: Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate.
NewClinical Research & Development Associate Director Myositis/Immunology AstraZeneca PlcClinical Research & Development Associate Director Myositis/ImmunologyGaithersburg, MDEssential: Advanced degree (Master's, PhD, or equivalent) in a scientific, medical, or health-related discipline related to inflammatory and autoimmune conditions, their biology and treatment, relevant scientific literature and clinical trials; Comprehensive knowledge of the drug development process; Demonstrated knowledge of AstraZeneca line and project management tools and processes; Good understanding of the therapeutic areas related to AZ products; Ability to understand integrated worldwide and regional delivery needs; Very good knowledge of oral and written communication in English; Ability to travel nationally and internationally. Internal: Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate.
Clinical Research Coordinator (52088) Gap Solutions, Inc.Clinical Research Coordinator (52088)Bethesda, MDCollaborate with clinical staff to ensure timely collection of: Pharmacokinetic samples, Pharmacodynamic samples, Blood specimens, Electrocardiograms (ECGs), Vital signs, Height and weight measurements, Wearable device data, Other protocol-specific procedures. The OCD provides the infrastructure required to conduct high-quality clinical research in a safe patient care environment, including protocol review, regulatory oversight, clinical informatics, data management, quality assurance, and clinical operations support.
Clinical Program Manager GuidehouseClinical Program ManagerBethesda, MarylandWe 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.