Hybrid/Remote – Travel Required
We are seeking a flexible and experienced Oncology Clinical Research Coordinator (CRC) or a newly transitioned Clinical Research Associate (CRA) to join our dynamic Clinical Operations team. This hybrid 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.
We also welcome international clinical research professionals who are authorized to work in the United States for any employer and bring prior hands‐on experience with U.S.-based clinical research trials and data management.
Remote work flexibility is available, with the expectation that team members adhere to each site's operational policies and requirements. Strong communication skills are essential, with an emphasis on real‐time responsiveness to logistical and operational questions from sites.
Key Responsibilities
Site Monitoring
- Conduct regular on‐site 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 Data Management 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 Data Management teams
- 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, Data Management, Biostatistics, and Regulatory 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).
- 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
- Willingness to travel regularly based on monitoring and recruitment requirements
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.