Website Lexitas

Summary: Provides operational project leadership and directly manages Clinical Research Associates (CRA’s) and Clinical Research Coordinators (CRC’s). Should be expert in the technical responsibilities of the position. Serves as a liaison with the sponsor and vendors across all functional areas of the project. Manages the project ensuring that the quality of interactions and communication across the project is consistent with the sponsor and department expectations.

Responsibilities:

  • Provides leadership to CRA’s and CRC’s in the planning, implementation, and closeout of clinical research projects.
  • Develops Clinical Management Plans, Monitoring Plans and Communication Plans
  • Reviews or designates review of monitoring trip reports.
  • Manages vendors, including the implementation and coordination of vendor’s Statements of Work/Scope of Work (SOW).
  • Serves as a primary study contact including regular team conferences calls and meetings across appropriate functional areas, management and vendors as necessary.
  • Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local Regulations.
  • Manages study budget and timelines. Identifies, resolves or escalates issues involving study timelines and deliverables.
  • Collects, tracks and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations
  • Evaluates current processes for efficiencies and quality as well as make recommendations to management for improvements.
  • Contributes, authors and reviews key clinical documents including project specific protocols, protocol amendments, informed consent forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates.
  • Identifies and establishes the suitability of study investigators and their investigative sites, and liaise with them to ensure compliance with all necessary study requirements, approvals and agreements (e.g. financial and confidential).

Requirements:

  • This position requires a B.S./B.A. or advanced degree in a health-related or scientific field and at least 8 years of experience in clinical research (or equivalent in education and experience)
  • 2 to 3 years of experience in managing clinical trials
  • Relevant experience as a CRA.
  • Study planning and set-up, maintenance, and close-out experience.
  • Must have good understanding of clinical research operations including GCP and regulatory requirements and operational procedures.
  • Experience in ophthalmology preferred. Experience in a CRO setting is strongly preferred.

Skills & Attributes:

  • Must be highly customer service oriented and have creative initiative with a positive attitude.
  • Understands and shares the organizational values of developing and maintaining good relationships internally and externally. Quality of interactions reflects emphasis on relationships.
  • Able to work in a fast paced environment and easily adapt to changing priorities.
  • Must have excellent management and communication skills (written and verbal), strong problem solving skills, and be detail oriented.
  • Advanced skills in computer operation, spreadsheet creation/maintenance, and word processing are essential.
  • Proficiency in some software system(s) as appropriate for needs of department required.
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