Senior Clinical Research Associate

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

Job Description

Role and Responsibilities

  • Plans, implements and monitors clinical research projects ensuring that studies are conducted per established procedures, policies, regulations and GCP.
  • Actively participates as a member of cross functional teams overseeing current projects and planning of future projects
  • Evaluates and analyzes clinical data, ensuring study and data integrity as well as ensuring subjects rights, welfare and safety are protected
  • Must have in-depth knowledge of good clinical practices (GCP), regulatory requirements and standard operating procedures
  • Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives
  • Maintains a high level of professional expertise through familiarity with clinical literature and participation in project team meetings, professional meetings and other educational opportunities
  • May draft materials or contribute to the development of clinical protocols, informed consent documents, project management plans, , patient instruction guides and case report forms
  • May require travel to conduct clinical monitoring of clinical sites to ensure data quality and adherence to the protocol
  • Works on complex issues where timely analysis of situations or data requires an in-depth evaluation of variable factors and is critical to meeting the scheduled goals of the project.
  • Determines methods and procedures on new assignments
  • May coordinate activities of other personnel (team lead)
  • Works under the direction of the Clinical Project Manager or Senior Clinical Trial Manager

Qualifications and Education Requirements

  • Bachelor’s degree in the biological sciences, masters preferred
  • Minimum 2 years’ experience as a CRA supporting an oncology clinical trial
  • 5+ years of related experience required

Preferred Skills

  • Demonstrated leadership capabilities especially in regard to CRO management
  • GCP compliance management and QC oversite of clinical trials capabilities
  • 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, transparency, and drive.

Join our Team

LOCAL Bay Area Candidates only

If you are interested, please submit a cover letter and your resume to