table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
- 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.
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. Complete details about Georgetown Universitys mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation. 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. 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. 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.
Beltsville, Maryland5 days ago Overview:  .
Responsible for supporting the management and coordination of tasks for multiple clinical research studies to include screening patients for eligibility and participates in the subject’s study visits and required activities per protocol. li>Axillary radiotherapy or axillary lymph node dissection in patients with clinically node-positive breast cancer undergoing upfront tailored axillary surgery: An international, randomized superiority trial (NOAX). Current research portfolio supported by this role includes data and biorepositories, associated utilization studies, cfDNA and CTC in breast cancer, and clinical trials (drug, device, surgical intervention). Subject matter expertise in Military Mental Health includes the ability to integrate the best available research with clinical expertise in the context of patient characteristics, such that the candidate is able to provide training and consultation that is empirically sound and accessible across a wide variety of contexts. CDP's mission is to lead the development of a community of military culturally mindful and clinically competent providers through the delivery of high-quality training and education, the convening of experts, and the dissemination of research-based treatment and the latest topics in military behavioral health. li>Willing and able to travel up to 60% for on-site monitoring visits across the West region; preference given to candidates residing in West region near major HUB airports to support efficient regional travel. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. 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. 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. 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. 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.
Clinical Research Associate I (East Coast: NY, FL, NJ, PA, OH, DC, MD) Premier Research International LLCClinical Research Associate I (East Coast: NY, FL, NJ, PA, OH, DC, MD)MD30+ days ago p>You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Premier Research is looking for a Clinical Research Associate I (East Coast: NY, FL, NJ, PA, OH, DC, MD) to join our Global Clinical Monitoring and Site Management team. 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. 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. Silver Spring, MD4 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. Fairfax, Virginia30+ days ago The company has over 250 eye care professionals and business support roles across a growing network of over 17 eye care clinic locations, spanning New Jersey, with plans to affiliate with other eye care practices in New Jersey, New York, Connecticut, Pennsylvania, Delaware, Maryland, and nationwide. - Responds to requests in a timely manner, gives/receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date manner.
ul>Acts as primary liaison to Principal Investigator (PI) to develop plans for investigator-initiated research projects; prepares budgets and assists in preparing grant proposals to sponsoring agencies; writes or assists in writing initial study protocol and instructional manuals; preparation of amendments to protocols and/or modification to study design, as appropriate. 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. Silver Spring, MD22 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. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). Applicants who are motivated in developing skills through onsite education in trauma informed care, harm reduction, and working with patients with a substance use disorder are encouraged to apply. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). This position is within the Maryland Addiction Consultation Service team, working to support evaluation and continuous quality improvement as part of a team that provides statewide consultation, training and technical assistance to health care providers and teams in an effort to increase access to evidence based treatment for substance use disorders. Silver Spring, MD4 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. 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.
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. li>Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry. Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. Silver Spring, Maryland16 days ago li class="WKSF">Job Description Job Description Key Responsibilities. Responsible for recruiting, screening, consenting, and enrolling patient in clinical trials. 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. 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.
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. Clinical Trials, Data Collection Methods, Detail-Oriented, Diagnostic Testing, Interpersonal Communication, Oral Communications, Organizing, Screenings, Written Communication Grade. Silver Spring, MD29 days ago REQUIRED DEGREE/EDUCATION/CERTIFICATION: Required to be a Registered Nurse licensed to practice in the state of Maryland, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. The Family of Companies (FOCs) includes Keaki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Pookela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. 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. Baltimore, MD30+ days ago 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. This Phase I study conducted at the Uniformed Services University Translational Medicine Unit, is a randomized, placebo-controlled, double-blind, 4-period crossover study comparing LT-120, an intranasal esketamine nasal spray, with intravenous racemic ketamine under fasted conditions. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. 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.
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