Clinical Research Associate I

Department/Group: Clinical Operations
Location: Burlingame, CA
Position Type: Full time

Job Description

Role and Responsibilities

  • Assists in the design, planning and implementation of the overall strategies and plans of clinical research projects
  • Monitors the entry of clinical data by clinical sites
  • Communicates with sites, CROs and other vendors  and maintains effective management of protocol objectives and study issues
  • May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms.
  • Reviews site’s informed consent forms against the consent template for presence of GCP requirements, protocol specific information and for accuracy 
  • Proficient in coordination and review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
  • Assists with sites and vendors issues and corrective action prevention plan resolutions
  • Ensures ongoing tracking of IND Safety Reports for assigned sites and works with Clinical Monitors to support drug safety with resolution of open queries
  • Assists with the management  of clinical site contracts, budgets and invoice process
  • Assists with vendor selection and management
  • Review, reconcile and process site and vendor invoices as assigned
  • Partners with team members and cross-functional teams
  • Thorough knowledge of FDA clinical trial regulations and ICH E6 clinical trial guidelines.. 
  • Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. 
  • Develops increased professional expertise through familiarity with clinical literature and participates in project team meetings. 
  • May conduct clinical monitoring of clinical sites to supervise and coordinate clinical studies. 
  • May assist with the creation and maintenance protocols, ICFS and other study management documents. 
  • May require travel to clinical sites.
  • Works on problems of a moderate scope where analysis of situations or data requires review of a variety of factors
  • Exercises judgment within defined procedures and practices to determine appropriate action
  • Receives general instructions on routine work, detailed instructions on new projects or assignments
  • Applies company policies and procedures to resolve a variety of issues

Qualifications and Education Requirements

  • Bachelor’s degree required
  • 2+ years of related experience required

Preferred Skills

  • Excellent teamwork and collaboration skills 
  • Proficient with Microsoft Office.
  • Able to build effective working relationships throughout the organization internally and externally to achieve goals.
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  • Work independently in an interdisciplinary, fast-paced, often changing environment.
  • Committed to the values of integrity, accountability, agility, and drive.

Join our Team

Local candidates only please!  If you are interested, please submit a cover letter and your resume to