Hybrid Clinicial Research Coordinator 2

Hybrid Clinical Research Coordinator 2

Tekberry is seeking an experienced Clinical Research Coordinator 2 to support our client within the School of Medicine. This role independently manages significant aspects of oncology clinical research studies, ensuring the successful execution of research protocols while maintaining regulatory compliance and exceptional participant care.

The ideal candidate will have hands-on experience supporting oncology treatment trials, particularly Phase I studies, within a healthcare institution. Candidates with experience limited to CRO or pharmaceutical CRA environments will not be considered.

Responsibilities

• Independently coordinate and manage all aspects of assigned clinical research studies
• Oversee participant recruitment, screening, enrollment, and retention efforts
• Develop strategies to achieve study enrollment goals and maintain participant engagement
• Manage study data collection processes and oversee data integrity
• Develop and maintain systems to organize, collect, monitor, and report research data
• Extract, analyze, and interpret study data to support research objectives
• Develop project timelines, milestones, and accountability measures
• Lead study meetings and prepare meeting documentation and minutes
• Collaborate with principal investigators, sponsors, and study teams
• Monitor and report serious adverse events and resolve sponsor queries
• Ensure ongoing compliance with study protocols, HIPAA, FDA regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements
• Prepare and submit IRB applications, renewals, and modifications
• Conduct audits of study operations and implement corrective actions when necessary
• Assist with study budget development and distinguish standard-of-care versus research-related procedures
• Track study milestones and support sponsor invoicing activities
• Mentor, train, and provide guidance to junior staff and students as assigned
• Support Investigational New Drug (IND) submissions to the FDA when applicable

Required Qualifications

• Bachelor's degree in a related field
• Minimum of 2 years of clinical research experience, or an equivalent combination of education and experience
• Direct experience supporting oncology treatment trials
• Experience supporting Phase I clinical trials
• Experience working onsite within a healthcare institution (hospital, academic medical center, or clinical setting)
• Experience with EPIC electronic medical records system
• Strong understanding of:
  • HIPAA regulations
  • FDA regulations
  • Institutional Review Board (IRB) processes
  • Good Clinical Practice (GCP) guidelines
• Knowledge of medical terminology
• Strong interpersonal, organizational, and communication skills
• Proficiency with Microsoft Office and research databases

Preferred Qualifications

• Experience supporting Phase II or Phase III oncology trials
• Previous experience in an academic medical center environment
• Experience independently managing multiple research protocols simultaneously
• Experience mentoring junior research staff
• Certification through ACRP or SOCRA preferred

Work Environment & Physical Requirements

• Hybrid work arrangement with onsite responsibilities at Stanford facilities
• Frequent standing, walking, bending, twisting, and participant interaction
• Occasional lifting, carrying, pushing, or pulling up to 40 pounds
• Regular use of computers, telephones, and electronic research systems
• May involve interaction with patients undergoing active treatment protocols
• Ability to work in a fast-paced clinical research environment while maintaining strict attention to detail and regulatory compliance

We need hard-working, reliable employees. If you're ready to contribute to groundbreaking oncology research and support studies that improve patient outcomes, we want to hear from you!

Tekberry is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Tekberry is a certified Minority Business Enterprise (MBE) and Disadvantaged Business Enterprise (DBE).

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