The Clinical Operations department at Calithera Biosciences is looking for an experienced Senior Clinical Research Associate who will be involved in the day to day management of early phase clinical studies in oncology. We are looking for someone who has great communication skills and can function in this role fairly independently.
Duties and Responsibilities
- Start-up activities: Assessing site feasibility, manage vendor selection process and be a part of vendor contract and budget negotiation.
- Manage study timelines.
- Making enrollment projections.
- Tracking enrollment.
- Risk management.
- Training/onboarding of new members.
- Support Clinical Operations vendor management activities, including but not limited to:
CRO staff training.
- Participate in CRO teleconferences.
- Sample management:
Tracking of patient samples: PK, PDn, biomarker, biopsies, radiology scans and reports
Sample reconciliation with vendors and EDC.
Working with internal team and external vendors to ensure samples are analyzed, data transferred, and reports generated.
Management of sample vendors.
- Management of Clinical Site Finances:
Approve site budgets and budget amendments
Review invoices to compare charges against expected costs
Meet with finance team to update budgets.
- Drive Clinical data review activities- data listing review, protocol deviation review, trend review.
- Participate in Site Initiations, Co-monitoring, and site close out activities.
- Review and approval of clinical study plans.
- Assist in the quality control of clinical documentation.
- Assist in the development of other study-related documents.
- Mentor CRAs and Clinical Assistants.
- Development of department SOPs.
- Collaborate with department members to identify Clinical Operations process, needs, and lessons learned.
Qualification and Requirements
- Bachelor’s degree or higher with a minimum of 5 years directly related experience.
- Experience with EDCs, eTMFs, IRTs.
- Travel: 20-40%
- Local Candidates only.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Interested candidates should submit their resume to firstname.lastname@example.org