Hybrid Clinical Research Coordinator 2

Hybrid Clinical Research Coordinator 2

Tekberry is seeking an experienced Clinical Research Coordinator 2 to support oncology clinical research studies within a leading academic medical environment. This role independently manages significant aspects of treatment trials, ensuring studies are conducted efficiently, safely, and in compliance with all regulatory requirements.

The ideal candidate will bring hands-on experience coordinating cancer treatment trials, particularly Phase I studies, within a hospital or clinic setting. Strong knowledge of regulatory requirements, EPIC proficiency, and the ability to work collaboratively with investigators, sponsors, and patients are essential for success in this role.

Responsibilities

• Independently coordinate and manage assigned oncology clinical research studies
• Oversee participant recruitment, screening, enrollment, and retention efforts
• Develop strategies to meet study enrollment goals and maintain participant engagement
• Manage study data collection processes and ensure data integrity
• Develop and maintain systems to organize, monitor, and report study-related data
• Extract, analyze, and interpret research data to support study objectives
• Lead study meetings and prepare related documentation and meeting minutes
• Collaborate with principal investigators, sponsors, and research teams to support study execution
• Monitor and report serious adverse events and resolve study-related queries
• Ensure ongoing compliance with HIPAA, FDA regulations, Institutional Review Board (IRB) requirements, and Good Clinical Practice (GCP) guidelines
• Conduct audits of study operations and implement corrective actions when necessary
• Assist with IRB submissions, modifications, and renewals
• Support Investigational New Drug (IND) activities when applicable
• Track study milestones and assist with sponsor invoicing and budget-related activities
• Train and mentor junior staff and students as assigned
• Identify opportunities to improve processes and implement best practices across studies

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 cancer treatment trials
• Experience coordinating Phase I treatment studies
• Experience working onsite within a hospital, clinic, or healthcare institution
• Proficiency using EPIC EMR
• Knowledge of:
  • HIPAA regulations
  • FDA regulations
  • Institutional Review Board (IRB) processes
  • Good Clinical Practice (GCP) guidelines
  • Medical terminology
• Strong interpersonal, organizational, and communication skills
• Proficiency with Microsoft Office and database applications

Preferred Qualifications

• ACRP or SOCRA certification
• Experience supporting oncology studies within an academic medical center
• Experience independently managing multiple research protocols simultaneously
• Experience mentoring junior research staff
• Familiarity with sponsor invoicing and clinical trial budget management

Work Environment & Physical Requirements

• Hybrid schedule requiring 3–4 days onsite each week
• 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
• 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 innovative 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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