Oncology-Clinical Research Associate/Recruitment Specialist

Role Summary

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.

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.

Responsibilities

• Site Monitoring
  • Conduct regular on-site and remote monitoring visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
  • Complete monitoring plans tailored to each study.
  • Review case report forms (CRFs) and source documents for accuracy and completeness.
  • Resolve site-related issues and manage investigational product logistics.
  • Maintain positive relationships with site staff and provide real-time support on patient eligibility, protocol logistics, and operational questions.
  • Deliver high-quality presentations during SQVs/SIVs.
• Recruitment and Retention Strategies
  • Develop and implement tailored patient recruitment and retention plans using approved vendors.
  • Collaborate with site staff to identify and overcome recruitment barriers.
  • Track and report recruitment and retention metrics, providing regular updates to the project team.
  • Prioritize recruitment support and re-training efforts for low-performing sites or those facing enrollment challenges.
  • Conduct additional in-service training and apply engagement strategies to boost recruitment.
  • Engage with site staff to ensure a positive study experience and address concerns.
• Communication and Collaboration
  • Serve as the primary point of contact for study sites, offering guidance and support.
  • Collaborate with cross-functional teams including project managers, data managers, and regulatory affairs.
  • Prepare and present study progress reports to internal and external stakeholders.
• Training and Development
  • Train and mentor site staff on study protocols, GCP, and regulatory requirements.
  • Stay current with industry trends and best practices in clinical research and site management.

Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field. Advanced degrees, including international clinical degrees, may be considered.
• Minimum 2-3 years of experience in oncology clinical research (CRC or CRA).
• Experience in CROs or academic institutions acceptable in lieu of direct sponsor experience.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong analytical and problem-solving skills.
• Excellent communication and presentation skills, especially for site-facing interactions.
• Ability to respond promptly to site inquiries and logistical needs.
• Willingness to travel 50% based on monitoring/recruitment requirements.

Skills

• Site-facing communication
• Monitoring and regulatory compliance
• Recruitment and retention strategy development
• Data review and accuracy checks
• Cross-functional collaboration

Education

• Bachelor’s degree in life sciences, nursing, or related field (as above).