Clinical Research Associate

South san francisco, CA

Essential Duties and Responsibilities:

Assist in managing and or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

  • Participate in and may facilitate cross-functional study teams, liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities
  • Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
  • Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
  • Accurately update and maintain clinical systems within project timelines
  • Provide regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
  • Participate in developing study plans and system set-up; participate in the preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
  • Participate in the preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
  • Work on study feasibility assessments and selection of countries and sites for study conduct
  • Create and conduct training sessions including investigator meetings and team trainings
  • Provide oversight and direction to study team members, including vendors, for study deliverables
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs

Qualifications:


  • BA/BS degree with at least 4 - 6 years clinical trial management experience, or advanced degree (MS) with at least 4 years clinical trial management experience
  • Must have strong knowledge of ICH/GCP guidelines
  • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
  • Strong experience in the management of CROs and other vendors
  • Proven project management skills and study leadership ability required
  • Must have excellent interpersonal, written and verbal communication skills, and administrative skills
  • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
  • Ability to roll up your sleeves and individually contribute results to a research and development effort
  • Ability to travel up to 25%

Experience

4 to 7 (Yrs)

Salary

$80,000 - $110,000

Skillset

CRA ICH/GCP Guidelines Management Of CROs Clinical Drug Development Processes Clinical Study Design Study Planning Management And Monitoring

Location

South san francisco, CA

Telecomute

No