Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) is a critical position within the SDP Oncology Clinical Department. This role will manage and oversee clinical trial site activities and will assist in managing or may lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable SDPO SOPs, GCP/ICH guidelines and other regulatory requirements. The Sr. CRA works collaboratively with internal and external team members and supports project team activities to ensure all study deliverables are completed on time and within budget.

Responsibilities

  • Participate in and may facilitate cross-functional study teams, liaise with other functional areas to accurately coordinate clinical study activities.
  • Coordinate clinical study timelines to meet critical milestones; provide regular updates on study progress and escalate issues that may jeopardize timelines and deliverables.
  • Provide monitoring oversight by reviewing monitoring schedules, metrics and reports and potential leadership of regional clinical monitor management for your assigned studies. Liaises with monitors to understand any trends on quality issues or other site issues to develop solutions.  May oversee or manage other clinical documentation and reports.
  • Tracks and reports project enrollment, builds and maintains study trackers, organizes and help lead cross functional project team meetings. 
  • Proactively identify and resolve clinical trial site issues that arise during study conduct; manage escalation of study-related issues.
  • Participate in developing study plans and systems; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
  • Participate in preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
  • Supports/assists with oversight and accountability of all third-party vendors.
  • Work on study feasibility assessments and selection of countries and sites for study conduct.
  • Create and conduct training sessions including investigator meetings and team trainings.
  • Provide oversight and direction to study team members, including vendors, for study deliverables.
  • Review/approve vendor/site invoices.
  • May mentor junior members of the team.
  • Other duties as assigned.

Qualifications

  • Minimum of 3 to 5 years CRA experience in the pharmaceutical/biotech industry
  • BS/MS/PhD in a related life science discipline is appreciated Must have strong knowledge of ICH/GCP guidelines
  • Prior oncology drug development experience preferred
  • Strong interpersonal, communication and leadership skills
  • Proficient with MS office suite
  • High level of organizational skills
  • Demonstrated ability to work independently in a matrix environment
  • Demonstrated ability to prioritize and manage multiple tasks simultaneously
  • Flexibility to accommodate changes in priorities and project needs
  • This position is not an onsite monitoring position but may require travel < 10% to sites to co-monitor/train, attend Investigator meetings, conferences etc.

Job Location: Cambridge, MA

Equal Opportunity Employer

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