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Senior Clinical Research Associate - Midwest


Senior Clinical Research Associate (CRA)-Midwest will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites (Midwest) to support ongoing and future OncoC4 clinical trials of novel immune therapies for various cancers.



  • Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial
  • Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations
  • Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects' rights, safety, and well-being are protected
  • Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
  • Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management
  • Performs investigational product accountability through physical inventory and record review
  • Participates & provides inputs on site selection activities
  • Supports audit/inspection activities as needed
  • Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
  • Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines


  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology
  • Knowledge of e-TMF and CTMS set up and maintenance processes
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Excellent written and verbal communication skills including good command of English
  • Proven skills in site management including independent management of site performance and patient recruitment
  • Effective time management and organizational skills
  • Ability to establish and maintain effective working relationships with coworkers


  • Bachelor's degree in Sciences from an accredited institution with strong emphasis in science and/or biology
  • Minimum of 3 to 4 years of clinical monitoring and direct site management experience in a bio/pharma/ Clinical Research Organization
  • Experience monitoring oncology trials is required
  • Applicants may be eligible to work remotely depending on location
  • Ability to travel domestically approximately 50% of working time
  • Current driver's license preferred

Please send CV and any inquires to hschiltz@oncoc4.com and wwu@oncoc4.com.