Senior Clinical Research Associate (CRA), Oncology

San Diego, CA or Remote

  • Samumed is currently looking for a talented and experienced Senior CRA with oncology experience to join its team.
  • The Senior CRA participates in the planning, coordination, and monitoring activities of oncology clinical trials
  • The Senior CRA will provide project support in the initiation, execution and close out of assigned clinical studies.
  • Remote work opens are available for this position

Specific Responsibilities

  • Managing designated clinical trials, including investigator selection, analysis of potential patient recruitment, and preparation of trial related documentation (administrative and regulatory documents, consent documents, study manuals, study tools)
  • Organizing Ethics Committee submissions with follow through to ensure successful outcome
  • Participating in /presenting at Investigator Meetings
  • Organizing study Site Initiation Visits (SIVs) and develop SIV slides
  • Ensuring procedures are in place for appropriate optimization of patients into the clinical trial
  • Preparing for monitoring visits and monitoring the assigned clinical trial sites (6-8 sites) following company Standard Operating Procedures (SOPs) and in accordance with Good Clinical Practice (GCP).  Monitoring includes the ability to perform all visit types, pre-study, site initiation, interim and close-out visits
  • Planning the requirements for clinical trial material (Investigational Product (IP) and non-IP)
  • Serving as first point of contact for investigators/site personnel inquiring about patient inclusion/exclusion criteria for ongoing trials
  • Maintaining project files including the Trial Master File (TMF), and the following: Ethics Committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment
  • Completing word processing, spreadsheet and database assignments, including, but not limited to, correspondence, records, reports, scanning, emailing, copying, filing and other tasks
  • Creating and managing Investigator Site File and ensuring that all documents within the file are complete
  • Creating and maintaining contact lists and supportive documents for the Clinical Development Department and vendors
  • Tracking completed Case Report Forms (CRFs), and setting up systems whereby completed CRFs are rapidly entered into the database.  Ensuring that queries generated during cleaning are responded to in a timely fashion
  • Managing patient recruitment strategies to increase patient randomization into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, and letters to GPs)
  • Reviewing all SAEs, ensuring medical director sign-off, that sites are notified, and that all company procedures are complied with
  • Participating in departmental planning sessions and SOP development
  • Complying with institutional and departmental policies and procedures
  • Co-monitoring/mentoring CRAs and CTAs
  • Assisting with vendor management and review of specifications


  • 4 year life sciences or health care related degree
  • Minimum 3 years of experience independent monitoring, including the monitoring of oncology clinical trials
  • Proficient in MS Office software
  • Excellent verbal and written communication skills

Please submit your resume or additional inquiries to Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.