Triphase is looking for exceptional people who…

  • Will help us assist patients to survive with cancer
  • Will succeed in a collaborative, innovative culture
  • Want to work in a dynamic, flexible environment with a company that offers competitive compensation and benefits, located in downtown Toronto, Ontario (Canada) and San Diego, CA (USA)

Most importantly, we are looking for people who can help us achieve our vision of bringing more effective, affordable treatments to cancer patients faster than the industry standards.
If you would like to join our team, please send us your CV with a cover note and apply directly through this website, telling us how you think you would make a difference.

Current Openings:

Director of Clinical Operations – San Diego, CA:

The Director of Clinical Operations reports to the Executive Director of Clinical Operations; coordinates and participates in the planning, preparation, execution, and reporting of assigned clinical studies; and provides mentorship to Clinical Operations staff.

Responsibilities

For Assigned Clinical Development Projects

  • Provide leadership and oversight to Clinical Operations Staff
  • Provide mentorship to Clinical Operations Staff and ensure that the team is adequately trained
  • Direct and manage vendors (e.g., CROs) and contractors (e.g., CRAs)
  • Oversee clinical study planning, preparation, execution, and reporting
  • Ensure that data entry and query resolution is completed in a timely manner to facilitate ad hoc and planned data analyses
  • Ensure GCP compliance
  • Develop successful working relationships with other internal functional areas and outside working groups
  • Develop and monitor clinical project budgets and timelines
  • Coordinate and prepare core clinical research documents (e.g., Protocols, Investigator’s Brochures, Annual Reports, Clinical Study Reports, etc.)
  • Establish and oversee the maintenance of project record keeping systems (e.g., TMF, working study files, etc.)
  • Establish and monitor progress towards Clinical Operations and Corporate goals
  • Serve as the Project Manager for assigned Clinical Development Project(s)
Competencies
  • Strong leadership skills with an ability to set a vision, to lead change, and to lead and mentor others
  • Excellent analytical and technical skills with a strong understanding of clinical operations and clinical research with pharmaceuticals and biologics
  • Excellent experience with, and understanding of, domestic and international regulatory and GCP requirements for pharmaceutical and biologic clinical trials
  • Excellent interpersonal communication skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines
  • Excellent writing skills with significant experience preparing INDs, Protocols, Investigator’s Brochures, Annual Reports, Clinical Study Reports, Regulatory Briefing Packages, and NDAs
  • Significant experience and understanding of how to work with and manage vendors (e.g., CROs), consultants (e.g., regional CRAs), and advisors (e.g., KOLs)
  • Proactive management style with exceptional problem solving skills
  • Excellent presentation skills; able to successfully work with and present to a wide variety of audiences
  • Strong working knowledge of PowerPoint and the tools used to analyze and communicate scientific data (e.g., Excel, Prism, etc.)
  • Experienced team leader and Project Manager with a strong working knowledge of Microsoft Project
Qualifications
  • Bachelor’s degree in a science or related field; advanced degree preferred
  • At least 15 years of experience managing successful domestic and/or international pharmaceutical and/or biologics clinical studies and staff
  • Significant oncology experience is strongly preferred

Clinical Research Associate (CRA) – San Diego, CA:

Overview:

The CRA will report to the Associate Director of Clinical and Regulatory Operations and is responsible for assisting with the design, administration, and monitoring of clinical trials; monitoring and managing clinical data from collection through locked database; and ensuring compliance with clinical protocols, their objectives, and ICH and GCP guidelines.

Responsibilities and Duties:
  • Assist with the design of clinical studies
  • Coordinate investigational site startup activities including, but not limited to, the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), organizing Ethics Committee submissions, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies
  • Work closely with the Clinical Trial Manager for each clinical study to manage contract vendors (e.g., CRAs) and Clinical Research Organization (CROs) to ensure all monitoring activities are conducted according to the Clinical Monitoring plan and relevant SOPs
  • Coordinate and maintain relevant tracking systems subject screening, enrollment, study visits, data entry, query resolution, etc.
  • Review clinical databases on a real-time basis to identify/resolve data entry issues, track and manage the query process, and to identify/report evolving trends in the data
  • Perform investigative site qualification, study initiation, interim monitoring, and close-out visits; co-monitor and train contract CRAs for these activities
  • Participate in project team meetings and conference calls to review progress of ongoing clinical trial
  • Assist clinical and regulatory operations staff with additional projects and tasks as determined by department and organizational needs
Requirements and Experience:
  • BS degree in a health-related science or equivalent (e.g., nursing)
  • 1-3 years’ experience as a CRA in the biotechnology or pharmaceutical industry
  • Willing to travel 50% of the time
  • Working knowledge of medical terminology; prior experience in oncology preferred
  • Mature, hard-working, team player that thrives in a fast-paced working environment
  • Ability to prioritize and multitask to ensure tasks that are completed on time
  • Possesses strong interpersonal and written communication skills
  • Excellent organizational and planning skills
  • Detail oriented and produces high quality work
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint with previous experience in SharePoint preferred
  • Performs job skills with minimal guidance
  • Completed (or is in the process of completing) a CRA certification Course

Applications, including cover letter and resume, may be sent to careers@triphaseco.com