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Sr. Clinical Research Manager (Neurology)

Johns Hopkins University
Remote, USA
Full-time
Senior · 6+ years experience
Remote
USD 64600-113300 yearly / year
Discovered 1 months ago

Full Job Posting

Specific Duties & Responsibilities

  • Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research.
  • Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to decisions impacting conduct of research.
  • Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the program.
  • Responsible for development and implementation of policy and procedures for clinical research within the program.
  • Facilitate effective teamwork among all involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc.
  • Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.
  • Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc.
  • Oversee preparation and submissions to IRB and act as liaison for regulatory issues on behalf of the PI.
  • Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies
  • Manage clinical research budget generation and financial management of the program.
  • Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc.
  • Analyze resource utilization by individual trials to ensure research needs are anticipated and met.
  • Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
  • Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data.
  • Ensure research staff maintain complete and accurate research data and charts and are well prepared for auditing and monitoring visits.
  • Lead study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
  • Contribute to manuscripts and presentations.
  • Other duties as assigned.
  • Bachelor's Degree in a related field.
  • Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
  • Demonstrated supervisory or lead experience.
  • Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
  • Master's Degree in a related field.
  • Certification as a Clinical Research Professional.
  • Advanced knowledge of GCP/ICH and local regulations.
  • Formal project management training or certification.

Technical Skills & Expected Level of Proficiency

  • Budget Management - Advanced
  • Clinical Resource Knowledge - Advanced
  • Data Management and Analysis - Advanced
  • Good Clinical Practices - Advanced
  • Finance Project Management - Advanced
  • Oral and Written Communications - Advanced
  • Program Development - Advanced
  • Record Keeping - Advanced
  • The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
  • Classified Title: Sr. Clinical Research Manager Role/Level/Range: ACRP/04/ME Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department name: SOM Neuro BIOS Personnel area: School of Medicine

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