Clinical Research Associate

Clinical Research Associate

Location : San Diego, CA (Hybrid 1 day/week)

Reports to : Associate Director Clinical Trial Management

Job Type : Full Time

FLSA : Exempt

Company Overview

Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company’s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.

Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.

Job Summary

We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase. No travel requirements are anticipated as all monitoring visits will be conducted remotely. Additional responsibilities will include support for the maintenance of monitoring related documents and trackers.

The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office.

We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required.

Key Responsibilities

• Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product.
• Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements
• Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities
• Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File
• Maintain the internal Trial Master File and periodically review
• Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required
• Monitor and track clinical research progress and provide status update reports
• Liaise with clinical sites and provide guidance on site/study issues

Required Qualifications

• Bachelor’s degree, preferably in science or healthcare
• Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology
• Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
• Excellent written and verbal communication skills
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint
• Ability to work independently and prioritize multiple projects in a fast-paced environment.

Physical / Work Environment

• This role is mainly a desk role requiring proper ergonomics.

Salary Range

• Annual base salary: $80,000 to $110,000

Equal Employment Opportunity Statement

Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.