Clinical Research Coordinator

3 weeks ago

Bethesda, United States Veear Projects Inc Full time
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. - Ad-Hoc
  • 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. - Ad-Hoc
  • Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily
  • Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues. - Ad-Hoc
  • Work products and documents related to protocol writing and editing; prepare amendments and all necessary forms; develop clinical research and clinical trial protocols, informed consent documents and other regulatory or study-related documents with special attention to the accuracy, consistency, and completeness of documents as well as proper format, spelling, and grammar (in conjunction with the PI and other relevant experts). - Daily
  • Work products and documents related to developing clinical documents; review and ensure that protocols and consents meet regulatory requirements and are written in a guideline compatible format. - Ad-Hoc
  • Work products and documents related to collaborating with staff on safety, regulatory and monitoring entities; coordinate with staff to integrate and ensure consistency of new/revised documents. - Ad-Hoc
  • Work products and documents related to managing, tracking and coordinating regulatory activities for the study protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closure. - Ad-Hoc
  • Work products and documents related to maintaining all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial; work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies. - Ad-Hoc
  • Work products and documents related to the organization of regulatory protocol meetings and/or reports; interact closely with the clinical research team and other branch/section staff involved in protocol management; guide the protocol navigation process. - Daily
Work Details:
  • 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. 1
  • Prepare and submit for review accurate source documents related to all research procedures. 2
  • 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 re-quired fields. 3
  • Enter data into research databases, systems and applications for ongoing studies. 4
  • Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5
  • 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 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.
  • Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
  • Show initiative and strong independent problem-solving skills in making recommendations for improving research team processes in general, and as needed to efficiently resolve complex or unpredictable situations.
  • Identify inefficiencies and recommend changes to research protocol documentation procedures that can improve study productivity.
Minimum Education:
  • Bachelor
Additional Qualifications:
Certifications & Licenses:
  • Association of Clinical Research Professionals Certified Professional (ACRP-CP)
  • Association of Clinical Research Professionals (ACRP)
  • Certified Clinical Research Professional (CCRP)
  • Certified Clinical Research Coordinator (CCRC)
  • Certified Clinical Research Associate (CCRA)
Field of Study:
  • Miscellaneous Health Medical Professions
  • Nursing
  • Community and Public Health
  • General Medical and Health Services
  • Neuroscience
  • Miscellaneous Biology
  • Cognitive Science and Biopsychology
  • Biology
  • Genetics
  • Health and Medical Preparatory Programs
  • Nutrition Sciences
  • Pharmacy Pharmaceutical Sciences and Administration
  • Treatment Therapy Professions
  • Communication Disorders Sciences and Services
  • Sociology
  • Miscellaneous Social Sciences
  • Miscellaneous Psychology
  • Clinical Psychology
  • Psychology
  • Social Work
  • Chemistry
Software:
  • Clinical Trial Management System (CTMS)
  • Electronic Medical Records System
  • Electronic Data Capture System
Skills:
  • Overseeing and documenting IP dispensing, inventory and reconciliation
  • Closing clinical trial sites down on completion of clinical trial
  • Ordering, tracking, and managing IP and trial materials.
  • Implementation of clinical trial site action plans
  • Training clinical trial site staff
  • Coordinating project meetings
  • Previous clinical trial work
  • Electronic medical records
  • Protocol review revision.
  • Phase I or II experience.
  • Patient confidentiality
  • Remote site monitoring
  • Regulatory compliance
  • Protocol development.
  • Clinical Research
  • Protocol writing.
  • Clinical Trials
  • Data Monitoring
  • Data Integrity
  • Patient care
  • Recruitment
  • Scheduling
  • Research
  • ICH/GCP
  • SOPs
  • Liaising with regulatory authorities
  • Liaise with ethics committee.
  • Protocol navigation.
  • Regulatory affairs
  • IRB submissions

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