Senior CRA

Menlo Park, CA 94025

Posted: 12/06/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16845

Job Description


Senior CRA

SF Bay Area

General Position Summary/Purpose:

The Senior Clinical Research Associate is a critical position within the clinical team. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. The Sr. CRA will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirement, Good Clinical Practice (GCP) guidelines and company SOPs.

 

Key Accountabilities/Core Job Responsibilities:
  • Independently manages the study start up activities for multi-center, US and/or global based studies
  • Performs on-site monitoring visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs as needed to assess the sites’ and CRA’ s overall performance
  • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports
  • Responsible for clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs
  • Leads or participates in vendor management activities
  • 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
  • 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
  • Mentors and coaches 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 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 to a research and development effort
  • 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 monitoring/ clinical trial management and vendor management experience

 

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Ron Tess

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