Senior Clinical Research Associate
ProTrials Research, Inc.
Summary
ProTrials is seeking a Senior Clinical Research Associate with oncology experience to join our team. The Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities 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%.
Job description
Here is what you will do:
- 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
- Manage and train site personnel on therapeutic area, 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
Here is what you bring to the table:
- RN or Bachelor 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 communications 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
Requirements
- RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
- Previous CRA experience demonstrating career growth in the CRA position
- Detail-oriented
- Excellent organizational skills
- Strong interpersonal and communications skills
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Flexible PTO
- 401(k) With Company Match
- Career Development Opportunities
Company overview
ProTrials Research, Inc. is a full-service clinical research organization (CRO) and certified woman-owned business headquartered in Los Gatos, California. Founded in 1996, the company has over 27 years of experience providing high-quality clinical development services to pharmaceutical, biotechnology, and medical device industry sponsors. ProTrials operates as a comprehensive CRO offering site management, clinical monitoring, project management, and supportive clinical development services across a wide range of therapeutic areas. With clinical operations personnel located throughout North America and globally, the company specializes in delivering operational excellence from early-phase studies through post-approval research. ProTrials distinguishes itself through its therapeutic expertise, established site relationships, and commitment to advancing meaningful clinical research that impacts patient lives. The company maintains a strong retention rate of 87% company-wide, reflecting its supportive workplace culture and focus on employee development.