Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Inizio Engage has a long-standing partnership with a leading biotechnology organization across Commercial, Patient Solutions and Medical Affairs businesses.
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.
Rockville, MD30+ days ago
The successful candidate will lead/co lead clinical research activities in support of three key initiatives: - Clinical research supporting activities within the Clinical Development Group (phase I - III trials) and regulatory filing of pipeline products.
Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates.
Keywords: 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.
Silver Spring, Maryland6 days ago
Holy 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.
Silver Spring, MD23 days ago
Holy 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.
Bethesda, Maryland12 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.
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. The Clinical Research Coordinator II (CRC II) is a lead coordinator on multiple surgical services (General Surgery, Burn, Breast, Endocrine, Trauma, Colorectal, and Surgical Oncology) and possibly transplant clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Research Nurse Manager in collaboration with a Research Director.
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.
Silver Spring, MD30+ days ago
Critical thinking skills ability to analyze clinical research protocols, assess study budgets, and analyze clinical trial contracts including payment terms. Excellent communication skills, ability to interact across the organization, and negotiate with clinical research sponsor/ clinical research organization personnel in a professional manner to represent CNH.
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.
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.
Silver Spring, MD23 days ago
Build financial console in OnCore CTMS including protocol amendments and updates to ensure accurate charge capture and segregation of research charges for all research related patient care as well as ancillary services such as investigational pharmacy. 3 years experience working in a clinical research environment including a stand-alone research site, a research department, or in research administration such as a centralized research office, or with an institutional review board (Required).
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: responsible for the scientific operations of research program studies, leading scientific research studies, executing the day-to-day operations of clinical research, and monitoring the safety of human subjects for a research organization. At one of the identified vacancies, 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.
Washington, DC30+ days ago
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Craft and convey clear, impactful and engaging messages that tell a holistic story. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
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>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.
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>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.
Piper Companies is seeking a Clinical Research Associate (CRA) to support the operational delivery of clinical trials across infectious disease, oncology, and cardiology programs. Collaborate cross-functionally with CRAs, CTMs, QA, and Data Management teams to resolve issues, mitigate risks, and maintain compliance with ICH-GCP and SOPs.
Silver Spring, MD5 days ago
Holy 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. Specialty care, home care and hospice services round out Holy Cross Health's high-quality and coordinated continuum of care that aims to improve health and let you live life on your own terms.
Gaithersburg, MD30+ days ago
Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. Essential Skills/Experience: Education/Experience required: Associate Director level : BS Life Sciences degree or simiilar, 7+ yrs medical writing experience in pharmaceutical industry or CRO.
li>Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of and performing job functions in compliance with rules regulations policies and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner. Ensure the safety and welfare of study subjects to include symptom review and management appropriate referral and follow-up and ongoing contact with subjects and primary care providers regarding current health status and response to study interventions.
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.
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.
Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP). Clinical Project Management, Clinical Systems, Clinical Trials Administration, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oncology Research, Oral Communications, Prioritization, Radiopharmaceuticals, SQL Databases, Stress Management, Written Communication
Grade.
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.
Within 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.
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.
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.
The Clinical Research Assistant II will contribute to research activities including patient recruitment, screening, data collection, protocol adherence, and regulatory compliance for a clinical trial that combines brain stimulation, pharmacotherapy, and behavioral interventions. HJF is seeking a Clinical Research Assistant II - DARPA to support clinical research evaluating novel interventions to improve mental health and prevent suicide in active-duty service members.
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.
p>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.
We 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 salary offered will depend on several factors including, but not limited to, relevant experience, skills, education, geographic location, internal equity, business needs, and other factors permitted by law. Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
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. Assists Principal Investigator (PI) as coordinator of a basic to moderately complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for ensuring regulatory compliance.
Job Description.
Fairfax, Virginia11 days ago
p/>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents.
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.
Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.