Clinical Research Associate (Cra)

The Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA) will be the primary liaison between the Investigator sites and the Company, responsible for overall site conduct and establishing important relationships with key site personnel and serve as an ambassador of the Company to the sites. Given the smaller CRO environment, we are seeking a candidate who is comfortable working in a hands-on, highly visible and autonomous type of role, and who is flexible and can positively collaborate across all levels within the clinical team and sponsor/vendors.

Responsibilities

• Lead assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with management on protocol discrepancies, improving efficiency, data integrity, etc.
• Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
• Perform site selection, initiation, monitoring and close-out visits of investigational sites for the Company’s clinical trials.
• Assist in the development and/or review of study plans, forms and tools, and site training materials (Sr CRA only)
• Conduct monitoring visit report review for junior or entry level CRAs (SrCRA only)
• Perform other duties as assigned by management.
• Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution.
• Develop collaborative relationships with investigative sites and personnel.
• Oversee and conduct monitoring activities, including remote monitoring and risk-based monitoring.
• Mentor junior or entry level CRAs (Sr CRA only)
• Review site regulatory documents, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites.

Qualifications

• Independent, field monitoring or co-monitoring experience of oncology clinical trials is required.
• Established a track record of building key productive relationships with study investigators, site staff and personnel, etc.
• Excellent verbal and written communication skills and conflict resolution abilities.
• Minimum 2 years total in clinical research experience is required at a CRO or pharma company.(5 years total of relevant clinical research experience for Sr. CRA)
• Early Phase oncology experience is a plus.
• A Bachelor’s degree in a scientific or life sciences discipline is required.
• Highly proficient in computer applications including Microsoft 365 and Office.
• Minimum 1 year of exceptional performance as a CRA (for internal promotion to Sr CRA only)
• Ability to independently prioritize tasks with excellent time management skills.

Location

• This is a home-based position. Occasional Site travel (<50% subject to business needs).

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