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Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. ul>- Interact regularly with principle investigators, research scientists, clinical research assistants, study recruiters, and administrative staff at the Complex Exposure Threats Center of Excellence, to ensure seamless research operations and maintain project momentum. Applicants who can independently lead routine project meetings, effectively communicate detailed progress updates, independently identify and resolve operational issues, and efficiently coordinate tasks across team members to maintain project momentum will be given priority.
li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.. li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.. Rockville, MD30+ days ago Reporting directly to the Vice President of Operations, Client Delivery Services, the Project Director collaborates with Practice Area Leads, Technical Operations leadership, and cross-functional teams to ensure excellence in execution, financial performance, and client satisfaction while driving innovation across the health-research ecosystem. This role provides scientific, operational, and programmatic leadership for a multidisciplinary team delivering comprehensive project management, regulatory oversight, data and safety monitoring coordination, analytics, and recruitment support for Alzheimer’s disease and aging-related studies. p>Keywords: In-House Clinical Research Associate, Clinical Research Associate, CRA, Clinical Trials, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Clinical Operations, FDA Regulations, ICH-GCP, GCP Compliance, IRB Submissions, OHRP Regulations, Clinical Research Organization, CRO, Study Coordinator, Regulatory Coordinator, Regulatory Specialist, Pharmaceutical Research, Healthcare Industry, Clinical Documentation, Microsoft Office, Contract-to-Hire, Clinical Study Support, Sponsor Studies, Site Management, Regulatory Compliance. Required Qualifications for the In-House Clinical Research Associate include: - 3-5 years of experience within a clinical research, pharmaceutical, CRO, sponsor, or clinical site environment.
li>Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies. At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Physician Assistants (PA) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. Baltimore, MD30+ days ago li>Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies. At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Nurse Practitioner (NP) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. This flexible, per-diem role is ideal for licensed nurses who want to gain or expand their experience in clinical research while contributing to studies that make a global impact. Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation • Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports • Contribute to contract review and negotiations with outside vendors and study sites or laboratories • Mentor CTMs and CRAs • Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: • Bachelors degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): • Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. Washington, District of Columbia30+ days ago p/>The Clinical Director plays a critical role in expanding IQVIA’s general surgery CRO capabilities by ensuring studies are executed in compliance with GCP, applicable regulations, SOPs, and evolving regulatory and clinical expectations for surgical and device-enabled therapies. The Clinical Director, General Surgery, is a senior clinical leadership role responsible for the scientific, regulatory, and operational oversight of general surgery therapy clinical trials conducted by IQVIA MedTech. Bethesda, Maryland11 days ago Reporting 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. p>Disease Group members: Principal Investigators, Physicians, Clinicians Lombardi Clinical Trials Office (CTO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff Clinical trial sponsors, auditors, and study monitors. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Washington, DC30+ days ago li>Independently 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. Bethesda, Maryland30+ days ago li>Maintain 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.). Salaries are determined based on several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.QUALIFICATIONS. Baltimore, MD30+ days ago At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation. Baltimore, MD30+ days ago At Parexel Baltimore Unit our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation. The Project Manager drives the planning, execution, and delivery of internal initiatives across Study Management functions and reports directly to the Director, Clinical Operations. + Demonstrated end‑to‑end clinical trial management experience across Phase II and Phase III studies, with strong understanding of operational requirements from study start‑up through close‑out. p>Bachelor's degree, BLS certification, and RN license in the District of Columbia required Three to five (3-5) years nursing experience in a hospital, clinic, or similar health care setting required At least two (1) year of clinical research experience required At least one (1) year of oncology and/or Cellular Medicine experience preferred Experience working inpatient/Intensive Care Unit settings Knowledge of clinical research, research processes, and Good Clinical Practice (GCP) Excellent verbal and written communication skills Excellent organizational skills and attention to detail Reliable and able to prioritize competing responsibilities. Disease Group members: Principal Investigators, Physicians, Clinicians Lombardi Clinical Trials Office team members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory and Tissue Technicians External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff Clinical trial sponsors, auditors, and study monitors. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Capture applicable field insights (feasibility, operational bottlenecks, patient pathways) and deliver them to global and local partners to lead early risk identification and inform protocol/process adjustments. p>Relationship Management & Site Support: Builds deep, multi-stakeholder relationships at strategic sites (including investigators, pharmacists, and administration), acting as a "site champion" and Primary Point of Contact to maintain cross-study consistency and address site needs. Cross-Functional Collaboration & Reporting: Partners seamlessly with internal teams (e.g., Medical Affairs, Study Start-Up) and CROs to ensure unified site communication, while maintaining meticulous documentation of site visits and interactions in central systems (e.g., Veeva). Baltimore, MD30+ days ago Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. This role requires a licensed Registered Nurse with proven clinical experience, preferably in a research setting, who is capable of working independently and collaboratively to ensure the safety, well-being, and informed consent of all research participants. As 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. As 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. Baltimore, MD30+ days ago Job Overview TheClinical Research Pharmacy Technician supports clinical research activities by assisting in the receipt preparation dispensing storage accountability and documentation of investigational and non-investigational products in a regulated research pharmacy setting. Founded in 2004 Pharmaron has invested in its people and facilities and established a broad spectrum of research development and manufacturing service capabilities throughout the entire drug discovery preclinical and clinical development process across multiple therapeutic modalities including small molecules biologics and CGT products. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. must respond to questions from patients in their portfolio in a timely manner; triage issues as they arise, facilitate communication between the PI/Sub-Is and patients for adverse events and clinical concerns, schedule future visits, send reminders for upcoming visit, ensure that the timing of the visit will work for any. Washington, DC23 days ago OBGYN at MWHC provides well visits, preventive screenings, breast health, genetic services, diagnostic imaging, preconception counseling, fetal assessment, labor and delivery (high-risk/low-risk), mother/baby, gynecology oncology care, benign gynecology care, maternal-fetal medicine, award-winning NICU care, urogynecology care, education, and more. Georgetown University and MedStar Health are seeking applicants for the position of Academic Chair of Obstetrics and Gynecology (OBGYN) for Georgetown University School of Medicine (GUSOM) and the Clinical Chair for MedStar Washington Hospital Center (MWHC). li>Coordinates with therapy teams and study leadership to ensure protocol‑driven timing, data collection, and session requirements are met, particularly in support of MDMA‑assisted therapy sessions. This position will be critical in ensuring compliance, safety, and efficiency at all stages of the study lifecycle, including but not limited to study startup, participant recruitment efforts, data and specimen collection, project tracking, and study operations. Washington, DC30+ days ago In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH), which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers, preserving the rich tradition of academics, research, and healing. Baltimore, Maryland30+ days ago li>Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies. At Parexel's Baltimore Unit (located in MedStar Harbor hospital) our highly trained and skilled Nurse Practitioner (NP) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. Baltimore, Maryland8 days ago div>At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Physician Assistants (PA) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies. Baltimore, MD30+ days ago p>This general interest posting is designed for experienced Clinical Research Coordinators (CRCs) who may not see a current opening that aligns with their location, but want to be considered for future opportunities across our growing network of clinical research sites nationwide. They play a hands-on role in advancing new therapies, supporting patients through clinical trials, and ensuring studies are conducted with the highest level of quality and care. Rockville, MD30+ days ago p>Job Summary: To provide leadership, strategic direction, and oversight for end-to-end clinical data management activities throughout the lifecycle of clinical trials - from study start-up through trial execution and study closeout - ensuring quality, compliant, and timely clinical data delivery. - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. As a Clinical Research Assistant, PRN (Registered Nurse), you'll play a key role in delivering life-changing research opportunities to participants but with the flexibility to work when and where it fits your life. Washington, DC17 days ago CRC serves as a key liaison between investigators, sponsors, and multidisciplinary teams, while supporting data integrity, resolving operational challenges, and mentoring pool coordinators to ensure high-quality, efficient research operations. Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Bethesda, Maryland30+ days ago li>Maintain 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.
This role is hybrid (2 days on-site) and will play a key role in supporting clinical trial operations by ensuring the TMF is accurate, compliant and audit-ready. Qualifications of the Clinical Trial Specialist: 1-3+ years of regulatory submission/IRB experience working for a CRO, pharmaceutical/biotech, or research institution. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross, Registered Nurse - Illinois Department of Financial and Professional Regulation, Registered Nurse - Missouri Division of Professional Registration. or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Summary: The Clinical Support Associate assists the Clinical Operations Team within a limited scope of defined responsibilities in carrying out one of the assigned roles (collection/processing of laboratory samples, data entry of clinical data or administrative/front office support). Data Entry Responsibilities: Assist in the conduct of clinical trials by performing data entry tasks in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs under the direction of the Clinical Research Team.
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