Sr. Consultant, Clinical Operations (Remote/Hybrid) Full Time NEW

Cardiff Oncology is a clinical stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers. This opportunity is eligible for remote or hybrid work location.

Position Summary:

Cardiff Oncology is currently looking for a hands-on senior level Clinical Operations consultant to provide expert level guidance for the management and completion of all clinical trials conducted by Cardiff Oncology. This consulting role includes supporting the development of documents for clinical research studies, including protocols, informed consent documents, case report forms, in collaboration with other corporate functions. This role will provide expertise to Cardiff for executing the clinical development strategy including vendor selection, development of clinical trial documents, selection and training of study sites, oversight of study conduct, data review and assembly of clinical study reports. This role will also assist with managing clinical outsourcing, providing oversight to the financial and budgetary aspects of clinical trials, and will provide input into resourcing of clinical projects.

Essential Job Responsibilities:

• Provide expertise and oversight in managing multiple clinical trials across all functional areas involved in the drug development process
• Oversee and coordinate all operational aspects of clinical trials to ensure corporate goals of time, cost and quality performance expectations are met
• Ensure trials are conducted in full compliance with ICH-GCP, FDA, EMA, and other applicable regulations
• Work with other functional areas, as needed, to develop clinical research protocols and other clinical trial-related documents (i.e., ICFs, CRFs, Pharmacy Manuals, Monitoring Plans, etc.)
• Provide input and oversight for the selection of clinical trials sites and training for site staff
• Function as the lead Clinical Operations advisor for site audits, including defining, scheduling, assessing, evaluating and resolving eventual outcomes
• Ensure monitoring reports are critically reviewed and appropriate follow-up is performed through resolution
• Plan and/or conduct site visits to establish and evaluate operational execution of studies
• Identify requirements and develop bids for clinical research activity providers such as CROs, and other specialty vendors (e.g. central laboratories, visiting healthcare providers, data management, site oversight, monitoring, and other vendors as required)
• Provide input in developing clinical study budgets, participate in ongoing financial forecasting
• Coordinate on-schedule delivery of clinical trial supplies in collaboration with CMC function
• Author and maintain SOPs as applicable

Minimum Qualifications:

• Bachelor’s degree in related scientific discipline (biology, psychology, neuroscience, nursing, epidemiology, public health, etc.) and a minimum of 15 years of relevant experience
• Master’s Degree, PhD or PharmD strongly preferred
• Experience in global phase III oncology clinical trials required
• Experience supporting all phases of clinical research, including US and international trials in the pharmaceutical/biotech industry, with extensive experience managing CROs and global vendors
• Knowledge of GCP, ICH, CFRs and other guidance documents and policies related to clinical trials operations requirements
• Experience developing and implementing protocols on a global level, providing training and overseeing clinical research studies
• Ability to conduct business travel (internationally and domestically) as needed, approximately 15-25%

The consulting rate for this role will be between $150 – $225 per hour. Actual compensation will be dependent upon the individual’s skills, experience, qualifications and location. This is a consultant role and will not be eligible for benefits. This opportunity is eligible for remote or hybrid work location.