Senior CRA

Redwood City, CA 94063

Posted: 04/15/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17394

Job Description



Senior CRA job description


General Position Summary/Purpose:



Key Accountabilities/Core Job Responsibilities:
  • Supports CTM and/or Study Director and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollments, safety, data management, etc.) to accurately coordinate clinical study activities
  • Leads or participates in vendor management activities
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documents
  • Independently manages the study start up activities for multi-center, US and/or global based studies
  • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports
  • Develop collaborative partnership with clinical sites to ensure that all clinical sites adherence to protocol, trained on study procedures and complies to all applicable GCP/ICH guidelines, regulations statutes and SOPs
  • Performs in-house routine data listing review
  • Assists 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
  • Mentors and coach junior staff new to Clinical Research (e.g. Clinical Trial Assistant)
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study related documents
  • Performs monitoring visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs to assess the sites’ and CRA’ s overall performance, as needed
  • Performs other duties and assignments as required for overall success of the projects. Duties my change based on the status of clinical programs and ongoing needed of the organization


Qualifications & Skills:
  • Working knowledge of ICH/GCP and FDA guidelines
  • Effective verbal and written communication skills
  • Attention to detail and organizational skills
  • Ability to “ roll up your sleeves” and individually contribute results in a smaller organization to supports other assigned duties
  • Ophthalmology experience preferred but not required
  • Proficiency in MS Word, Excel and PowerPoint
  • Ability to travel up to 20%


Education Requirements (degree, certifications, etc.):

BS/BA, RN, or equivalent with at least 4 years of clinical trial management and vendor management experience/ clinical trial monitoring


Meet Your Recruiter

Ashley Lee

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