Senior Clinical Research Associate - Phase II Oncology
- Bayside Solutions
- San Jose, California
- Full Time
Senior Clinical Research Associate - Phase II Oncology
in San Jose, California
Overview
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
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s
in San Jose, California
Overview
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
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s
Job ID: 490918822
Originally Posted on: 8/27/2025
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