Clinical Trial Associate

We are seeking a highly motivated individual to join Mirati Therapeutics as a Clinical Trial Associate (CTA) within the Clinical Science/Operation Teams, reporting into a Director of Clinical Science. The CTA will interact with Clinical Science/Operation teams and collaborate effectively with CROs and vendors. The CTA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

Role Responsibilities

• Support all aspects of Mirati Therapeutics' clinical trials from initiation, planning, execution, maintenance and close-out.
• Collaborate/Interact with CROs and vendors.
• Review and assess study documents required for site activation and investigational product release.
• Review Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
• Support in the review of invoices from vendors/consultants as per contract.
• Support in the review of eCRFs, eCRF guidelines, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
• Support the planning of Investigator Meetings.
• Manage the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
• Additional activities may be assigned as appropriate.
• Travel as required to carry out responsibilities.
• Participate in the development, review and implementation of departmental SOPs and processes.

Qualifications:

• Bachelors or equivalent in a scientific or health care field preferred.
• Minimum of 1-3 years of relevant experience required.
• Experience in oncology clinical trials preferred.
• Clinical operations experience at a small or mid-size company.
• Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
• Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
• Excellent verbal and written communication skills.
• Ability to collaborate and respond to changing circumstances and needs.
• Ability to travel up to approximately 15-20%.