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Clinical Protocol Coordinator

Company: Kelly Services
Location: Bethesda
Posted on: November 24, 2022

Job Description:

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Protocol Coordinator with the National Institutes of Health in Bethesda, Maryland.This is a long-term contract position which offers: - Competitive salary with comprehensive benefit package - Opportunity to work at NIH, the world's foremost medical research center - Learn more about what Kelly can do for you at www.kellygovernmentsolutions.comOBJECTIVE: The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. TASKS:

  • Assists researchers with protocol development, assembly and review of clinical trial documents.
  • Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts
  • Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids
  • Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation
  • Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation
  • Assists researchers develop and maintain trial related documents and operational procedures.
  • Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports
  • Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence
  • Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary
  • Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports
  • Assist researchers track and review adverse event files and report events in accordance with Institutional Review
  • Board IRB processes and policies
  • Maintains study databases and conducts basic analysis.
  • Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals
  • Assist researchers prepare, review and submit clinical data to monitoring agencies
  • Assists researchers collect, distribute and file regulatory documents.
  • Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System
  • Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others
  • Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval
  • Assist researchers prepare submissions to regulatory bodies in support of clinical trials
  • Provides technical support to researchers and the clinic.
  • Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research
  • Program
  • Prepare draft documents for senior staff review
  • Coordinate with other offices eg, Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new revised
  • documents with policies
  • Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities
  • Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings
  • Develop clinical research informed consent and other ethics and regulatory related documentation description
  • Develop protocol documentation including schemas, patient calendars and teaching aids
  • Prepare study reports and status updates, including amendments, audits and other administrative documentation
  • Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports
  • Collects and distributes regulatory documents.
  • Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System
  • Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals and others
  • Prepare researcher communication with IRB and NIH Clinical Center for protocol approval
  • Prepare submission documentation for regulatory bodies in support of clinical trials
  • Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure
  • Develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts
  • Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety
  • requirements, ethics clearances, and technology transfer
  • Organize regulatory protocol meetings and/or reports, as well as attend other research team staff meetings; interact closely with the research clinical team and other staff involved in protocol management; guide the protocol navigation
  • process
  • Maintain documentation of clinical research training of staff
  • Meet with investigators and advise them of the documentation and approvals they will need to initiate a clinical study based on the type, location and complexity of the proposal REQUIREMENTS. The contractor must have:Recommended 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 - Biology - Multi-Disciplinary or General Science - Health and Medical Preparatory Programs - General Medical and Health Services - Neuroscience - Health and Medical Administrative Services - Cognitive Science and Biopsychology - Miscellaneous Biology Software - Clinical Trial Management System (CTMS) - Electronic Medical Records System - Electronic Data Capture System Skills - Liaising with regulatory authorities - Training clinical trial site staff - Previous clinical trial work - Phase I or II experience - Regulatory compliance - Protocol development - Protocol navigation - Regulatory affairs - Clinical Research - Protocol writing - IRB submissions - Clinical Trials - On-site visits - Data Integrity - Research - ICH/GCP Work Location: Bethesda, MD 20817When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.

    Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren't contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

    As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly's Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what's next.

    It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

Keywords: Kelly Services, Bethesda , Clinical Protocol Coordinator, Healthcare , Bethesda, Maryland

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