Job Description

Senior Clinical Research Associate - Phase II Oncology

Direct Hire Full-Time Role

Salary Range: $120,000 - $140,000 per year

Location: San Jose, CA - Hybrid Role

Job Summary:

The Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%.

Duties and Responsibilities:

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits.
• Managed and trained site personnel on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Manage and track the preparation and return of investigational supplies at individual sites.
• Monitor and document investigational product dispensing, inventory, and reconciliation.
• Monitor and document laboratory sample storage and shipment.
• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.
• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues.
• Review data queries and listings, and work with study centers to resolve data discrepancies.
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues.
• Maintain complete and accurate study files and review files to ensure all appropriate documentation is present.
• Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
• Serve as a resource for project team members, including supporting CRA I and CRA II staff by providing solutions to resolve issues.

Requirements and Qualifications:

• RN or Bachelor's and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, or training, and previous CRA experience demonstrating career growth in the CRA position
• Detail-oriented
• Excellent organizational skills, strong interpersonal and communication skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to efficiently perform and prioritize multiple tasks
• Familiarity with the medical and pharmaceutical industries, and related terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Ability to travel, including by air or by car, on short notice
• Proficiency in Microsoft Word, Excel, and PowerPoint

Desired Skills and Experience

Phase II Oncology, Clinical Research Associate, CRA, clinical trials monitoring, clinical trial management, protocol compliance, SOPs, ICH GCP, regulatory requirements, site monitoring, qualification visits, initiation visits, interim visits, close-out visits, site personnel training, therapeutic area expertise, source documentation, case report form completion, investigational product management, drug accountability, laboratory sample management, enrollment tracking, protocol deviations, SAE reporting, laboratory abnormalities, source data verification, SDV, data integrity, query resolution, data discrepancy resolution, regulatory documentation, study files maintenance, investigator communication, coordinator communication, team collaboration, RN, biological sciences, FDA regulations, medical terminology, pharmaceutical industry, detail-oriented, organizational skills, interpersonal skills, communication skills, problem-solving, multitasking, prioritization, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, 65% travel

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