Oncology Clinical Research Associate - Onsite /Travel Required

Job Description

Job Description

About the Company:

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

Bria-IMTTM, BriaCell’s lead candidate, was awarded Fast Track status by FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). MBC is breast cancer that has spread to other tissues. Bria-IMTTM is a targeted cell-based immunotherapy.

Bria-OTSTM, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer, and other cancers.

Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

About the Position:

We are seeking a flexible and experienced Oncology Clinical Research Coordinator (CRC) or newly transitioned Clinical Research Associate (CRA) to join our Clinical Operations team. This position will be based at BriaCell’s Philadelphia labs/offices and requires the individual to work onsite when not traveling for monitoring, site support, or other study-related activities. The role supports oncology clinical trials and is open to candidates with experience in CROs or academic institutions, even if they lack direct sponsor experience.

In addition to clinical operations expertise, the ideal candidate will bring a strong background in data management, data analytics, and statistical interpretation, with demonstrated experience analyzing clinical trial data to support study execution, monitoring, and decision‐making.

Strong communication skills are essential, including the ability to respond promptly to site questions and provide clear, real-time guidance on logistical and operational matters. Team members are also expected to understand and follow each site’s operational policies and requirements.

 

Responsibilities:
Site Monitoring

• Conduct regular onsite and remote monitoring visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements
• Execute monitoring plans tailored to each study
• Review case report forms (CRFs), source documentation, and data entries for accuracy, completeness, and consistency
• Identify data discrepancies and collaborate with clinical operations team members to ensure timely query resolution
• Resolve site-related issues and manage investigational product logistics
• Maintain strong relationships with site staff and provide real-time support on eligibility, protocol logistics, and operational questions
• Deliver high-quality presentations during SQVs/SIVs

Data Management, Analytics & Statistical Support

• Review and interpret clinical trial data to identify trends, risks, and data quality issues
• Support data cleaning, query management, and reconciliation activities in collaboration with clinical operations team.
• Analyze enrollment trends, protocol deviations, and site performance metrics
• Apply basic statistical concepts to interpret trial data and support operational decision-making
• Contribute to development of data tracking tools, dashboards, and performance reports
• Ensure accuracy and completeness of data within EDC and other clinical systems (CTMS, IRT)
• Participate in cross-functional data review meetings and support data-driven study execution

Recruitment and Retention Strategies

• Develop and implement tailored patient recruitment and retention plans using approved vendors
• Analyze recruitment data and site performance metrics to drive strategic improvements
• Collaborate with site staff to identify and overcome recruitment barriers
• Track and report recruitment KPIs and provide actionable insights to the project team
• Prioritize recruitment support and re-training for underperforming sites
• Conduct in‐service training and apply engagement strategies to improve enrollment

Communication and Collaboration

• Serve as the primary point of contact for study sites
• Collaborate cross-functionally with Clinical Operations, Regulatory and Discovery teams
• Prepare and present study progress reports, including data trends and analytics insights, to stakeholders

Training and Development

• Train and mentor site staff on protocols, GCP, data entry expectations, and system use (EDC/CTMS)
• Stay current with industry trends, data management practices, and evolving regulatory expectations

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field required
• Clinical degree (MD, RN, PharmD, or equivalent) preferred.
• Experience in data management, clinical data review, and/or data analytics required
• Background in statistics, epidemiology, or data analysis strongly preferred
• Minimum 2–3 years of oncology clinical research experience (CRC or CRA)
• Experience in CROs or academic institutions acceptable in lieu of direct sponsor experience
• Strong understanding of GCP, ICH guidelines, and regulatory requirements
• Demonstrated ability to interpret clinical trial data and apply analytical thinking
• Proficiency with EDC systems, CTMS, and data tracking/reporting tools
• Excellent communication, presentation, and problem-solving skills
• Ability to respond promptly to site inquiries and logistical needs
• Ability to travel regularly based on monitoring and recruitment requirements

To apply , please visit briacell.com and click on “About Us” and submit your application through the Careers section.

Equal Employment Opportunity Statement

BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Third-Party Agency Statement

BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.

 

\nCompany Description

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

Company Description

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.