Clinical Research Associate

Summit Therapeutics

Palo Alto, CAFull-timePosted Apr 28, 2026

Behavioral Health Market Context

Latest national behavioral health workforce report (2026-W22)California behavioral health workforce newsBrowse all behavioral health workforce news
Apply Nowvia Experteer.ch

Qualifications

  • •A minimum of 3+ years of clinical research experience in conducting clinical trials
  • •Prior phase II or III experience required
  • •A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
  • •Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
  • •Ability to travel internationally to visit clinical sites and for study meetings
  • •Amount will vary upon project needs (up to 20%)
  • •Enjoys building relationships with KOLs and site personnel
  • •Willing to travel to establish relationships
  • •Ability to successfully engage and work collaboratively with global team members/colleagues
  • •Ability to support building and delivery of patient enrolment strategies
  • •Excellent interpersonal and decision-making skills
  • •Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives
  • •Ability to review and assess clinical data
  • •Possesses excellent planning, time management & coordination skills
  • •Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  • •Excellent written and oral communication skills
  • •13 more items(s)

Responsibilities

  • •The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out
  • •This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director
  • •The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial
  • •Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
  • •Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
  • •Initiates and builds solid professional relationships with clinical site staff
  • •Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
  • •Creation and development of study trackers
  • •Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
  • •Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc
  • •Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
  • •Following and implementing assigned study related plans, processes, agreements, and guidelines
  • •Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
  • •Reviews and approves essential document packages to enable timely site activations
  • •Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
  • •Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
  • •Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
  • •Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
  • •Perform periodic QC of the TMF
  • •Oversee the execution of clinical trial activities in accordance with Good Clinical Practices
  • •Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
  • •Ensures the study is "inspection ready" contemporaneously
  • •Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
  • •All other duties as assigned
  • •Tenacity to work in a fast-paced team environment
  • •22 more items(s)
Apply for this Position

More Jobs