Current jobs related to Clinical Research Coordinator - Bethesda - Nextonic Solutions LLC
-
Clinical Research Coordinator
2 days ago
Bethesda, Maryland, United States BioSpace, Inc. Full timeJob Title: Protocol Nurse Coordinator II/IIIJoin our team of dedicated professionals at BioSpace, Inc. as a Protocol Nurse Coordinator II/III. In this role, you will play a critical part in the success of our clinical research initiatives.About the Role:We are seeking a highly skilled and experienced nurse to manage clinical research protocols, ensuring...
-
Clinical Research Coordinator
7 days ago
Bethesda, Maryland, United States Cape Fox Federal Contracting Group Full timeClinical Protocol Coordinator Job DescriptionCape Fox Federal Contracting Group is seeking a highly skilled Clinical Protocol Coordinator to join our team in Bethesda, MD. As a key member of our clinical research team, you will play a critical role in the development and management of clinical trials.Key Responsibilities:Assist researchers with protocol...
-
Clinical Research Associate
3 days ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeJob Title: Nurse Practitioner or Physician Assistant I/IIJoin the Frederick National Laboratory for Cancer Research as a Nurse Practitioner or Physician Assistant I/II and contribute to the advancement of clinical research in neuroimmunological diseases.About the Role:We are seeking a highly skilled and motivated Nurse Practitioner or Physician Assistant to...
-
Research Nurse Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Research Nurse Specialist to join our team at Guidehouse. As a key member of our clinical research team, you will play a critical role in supporting the execution of clinical trials and ensuring the highest level of patient safety and data integrity.Key ResponsibilitiesProtocol Coordination: Provide expertise in...
-
Clinical Research Nurse III
2 weeks ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeJob SummaryWe are seeking a highly skilled Clinical Research Nurse III to join our team at the Frederick National Laboratory for Cancer Research. As a key member of our Clinical Research Directorate, you will play a critical role in supporting the conduct of clinical trials that investigate the prevention, diagnosis, and treatment of cancer, infectious...
-
Research Coordinator
2 weeks ago
Bethesda, Maryland, United States The Geneva Foundation Full timeAbout The Geneva FoundationWe are a leading organization dedicated to advancing medical research and improving human health. Our team is passionate about making a difference in the lives of others, and we are seeking a highly skilled and motivated individual to join our team as a Research Coordinator.Job SummaryThe Research Coordinator will provide critical...
-
Research Nurse Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Research Nurse Specialist to join our team at Guidehouse. As a key member of our clinical research team, you will play a critical role in supporting the development and implementation of clinical trials.Key ResponsibilitiesProtocol Coordination: Provide expertise in protocol coordination and implementation,...
-
Research Nurse Specialist
2 weeks ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Research Nurse Specialist to join our team at Guidehouse. As a key member of our clinical research team, you will be responsible for coordinating and implementing research protocols, managing data and study activities, and ensuring compliance with regulatory requirements.Key ResponsibilitiesProtocol Coordination:...
-
Clinical Research Coordinator II
1 week ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Coordinator II to join our team at the Henry M. Jackson Foundation for the Advancement of Military Medicine. As a key member of our Infectious Disease Clinical Research Program, you will play a critical role in supporting the HIV Natural History Study.Key ResponsibilitiesScreening and...
-
Clinical Research Nurse III
2 months ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeClinical Research Nurse III - Center for Immuno-Oncology (CIO) Job ID: req3984 Employee Type: exempt full-time Division: Clinical Research Program Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer...
-
Clinical Research Nurse III
3 months ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeClinical Research Nurse III - Center for Immuno-Oncology (CIO) Job ID: req3973Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer...
-
Research Nurse Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Research Nurse Specialist to join our team at Guidehouse. As a key member of our clinical research team, you will be responsible for coordinating and implementing clinical trials, ensuring patient safety and study integrity.Key ResponsibilitiesManage clinical and research support activities to ensure patient...
-
Clinical Study Coordinator II
1 month ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeClinical Study Coordinator II - LOCAL Job ID: req4057Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated...
-
Clinical Research Navigator
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Navigator to join our team at Guidehouse. As a Clinical Research Navigator, you will play a critical role in supporting the development and implementation of clinical research protocols, ensuring compliance with regulatory requirements and maintaining accurate records.Key...
-
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeHenry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a non-profit organization dedicated to advancing military medicine through scientific research and support. We partner with military, medical, academic, and government institutions to achieve this mission.We are seeking a highly motivated Clinical Research Coordinator II to join...
-
Clinical Research Coordinator II
4 months ago
Bethesda, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJoin the HJF Team!The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. 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...
-
Clinical Research Nurse
4 days ago
Bethesda, Maryland, United States Cape Fox Shared Services Full timeResearch Nurse OpportunityCape Fox Shared Services is seeking a highly skilled Research Nurse to support our team in Bethesda, MD. As a Research Nurse, you will play a critical role in the success of our clinical research studies.Key Responsibilities:Recruit and follow patients for clinical and basic research studies on HIV vaccines and emerging/re-emerging...
-
Clinical Research Physician
3 weeks ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeInfectious Disease Physician - Transplant Specialty Job ID: req3906 Employee Type: exempt full-time Division: Clinical Research Program The Frederick National Laboratory for Cancer Research operates as a Federally Funded Research and Development Center (FFRDC) dedicated to addressing critical challenges in biomedical sciences, particularly in cancer and...
-
Clinical Research Protocol Specialist
3 weeks ago
Bethesda, Maryland, United States Axle Full timeJob OverviewAxle is a pioneering organization in the fields of bioscience and information technology, dedicated to enhancing translational research, biomedical informatics, and data science applications for research institutions and healthcare entities both domestically and internationally. Our team comprises specialists in biomedical science, software...
-
Clinical Research Navigator
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Navigator to join our team at Guidehouse. As a key member of our Clinical Trials Unit, you will play a critical role in supporting the development and implementation of clinical research protocols.Key ResponsibilitiesDevelop and review clinical research protocols and related documentation,...
Clinical Research Coordinator
4 months ago
Position Summary
The primary role for this Research Coordinator (RC) position is to provide clinical research coordination through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.
Deliverables:
- Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned.
- Manage conflicts/issues in clinical research setting; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols.
- Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes.
- Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues.
- Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.
- Prepare and submit for review accurate source documents related to all research procedures.
- Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields.
- Enter data into research databases, systems and applications for ongoing studies.
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Assist preparing and submitting for review accurate source documents related to all research procedures.
- Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
- Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
- Participate in developing and maintaining research protocol documentation and operations.
- Maintains all professional licenses and certifications, if applicable maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
- Collects research data and prepares information for inputs and analysis.
- Verify study participant information and collect data and results of testing.
- Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
- Set up, format and enter data into spreadsheets to analyze information and create reports.
- Supports the development of forms and questionnaires.
- Assist researchers develop, maintain and complete study data collection forms and source documents.
- Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
- Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
- Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
- Assist researchers design patient Case Report Forms (CRFs).
- Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
- Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
- Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
- Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
- Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
- Assist researchers with the collection and analysis of research data and samples.
- Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
- Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
- Monitors subject's progress and reports adverse events.
- Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
- Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
- Update and maintain logs and records of patient and family contacts.
- Provide continuity of care to patients enrolled on assigned protocols.
- Assesses participants understanding of the information provided during the informed consent process.
- Assesses ongoing consent through discussions with participants and reinforcement of education.
- Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
- Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
- Supports assembly, development and review of new research projects.
- Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse
- Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.
- Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
- Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.
- Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
- Supports the creation and management of clinical websites and web-based tools.
- Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
- Collaborate with information technology (IT) staff to perform updates to a variety of websites.
- Create mock ups and visualizations to illustrate to web developers how to execute web enhancements or new web requirements.
- Organizes and performs clinical research, utilizing internet and other available clinical resources.
- Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
- Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
- Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.
- Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
- Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
- 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.
- Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
- Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.
- Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
- Maintains the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
- Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems.
- Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
- Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals.
- Notes trends in toxicities, participant information, and data collection points.
- Creates and updates protocol operating policies and procedures eg MOPs as needed.
- Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.
- Serves as a communication liaison between interdisciplinary team and the research participant.
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
- Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
- Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.
- Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard
- Operating Procedures and regulatory processes and considerations.
- Organize, prepare and distribute informational materials and provide support to the educational mission of the study.
- Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators.
- Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.
- Mentor new clinical research coordinators on all aspects of research support.
- Performs problems-solving and improves processes as needed to resolve complex and or unpredictable situations.
- Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
Visa Sponsorship:
No
Agency / Institute:
NIH/NINDS