Associate, Clinical Operations
Department: Integrative Sciences
Employment Type: Full Time
Reference Number: 2143741
Job Description Summary
The Associate, Clinical Operations provides operational support for the Mirati Clinical Operations team, working collaboratively with CROs and vendors (including both U.S. and Ex-U.S. regions).
- 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.
- Participate in the development, review and implementation of departmental SOPs and processes.
What is Required
- 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.
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.
Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.
Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.
Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.