Clinical Research Associate

Burlingame, California
Aug 24, 2018
Required Education
Bachelors Degree
Position Type
Full time

Role and Responsibilities

  • Participates in the design, planning and implementation of the overall direction of clinical research projects
  • Works closely with sites and vendors to ensure compliance with overall clinical objectives and protocol
  • Evaluates and analyzes clinical data
  • Communicates with sites and vendors  and maintains effective management of 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 CRAs to support drug safety with resolution of open queries
  • Assists manager/Clinical Program Manager with the investigator contract, budget, and payment process
  • Develops basic knowledge in vendor selection and management
  • Prepare site payment tracking for management review
  • Partners with team members and cross-functional teams
  • Must have knowledge in reference to good clinical practices regulations 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 participates in project team meetings. 
  • May conduct clinical monitoring of field sites to supervise and coordinate clinical studies. 
  • May participate in writing protocols. 
  • May require travel to field 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 preferred
  • 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.