Clinical Research Coordinator

Position Summary

The Clinical Research Coordinator is responsible for coordinating and managing clinical trial activities, including patient screening, enrollment, data collection, regulatory compliance, and ongoing patient monitoring. This individual works closely with physicians, research sponsors, patients, and other healthcare professionals to ensure successful execution of clinical research studies.

Responsibilities

• Screen potential patients for protocol eligibility.
• Present clinical trial opportunities and study details to patients and families.
• Participate in the informed consent process and enroll eligible patients into clinical trials.
• Assist with patient care activities required by study protocols.
• Monitor patient participation and ensure protocol compliance throughout the study.
• Collect, enter, and report study data accurately and timely.
• In collaboration with physicians, review patients for:
  • Changes in condition
  • Adverse events
  • Concomitant medication use
  • Protocol compliance
  • Response to study treatment
• Thoroughly document all research-related activities and findings.
• Maintain accurate and complete study records.
• May dispense investigational medications in accordance with protocol requirements.
• Maintain investigational drug accountability and documentation.
• Assist in the collection, preparation, and maintenance of regulatory documents.
• Ensure compliance with US Oncology Research (USOR) Standard Operating Procedures (SOPs), FDA regulations, and Good Clinical Practice (GCP) guidelines.
• Participate in monitoring visits, audits, and quality assurance activities.
• Schedule and coordinate sponsor monitoring and auditing visits as needed.
• Serve as a liaison with study sponsors, monitors, and auditors.
• Assist with collection, preparation, packaging, and shipment of laboratory specimens to central laboratories and vendors.
• Complete Hazmat and/or IATA training as required.
• Participate in mandatory training, continuing education, and research-related learning opportunities.
• Stay current on clinical research regulations, protocols, and best practices.

Qualifications

• Associate degree in a clinical, scientific, or healthcare-related field required; Bachelor's degree preferred.
• Minimum of one (1) year of experience in a clinical or scientific healthcare setting required.
• Oncology experience strongly preferred.
• Experience working directly with physicians preferred.
• Proficiency in Microsoft Office applications required.

Knowledge, Skills & Abilities

• Excellent verbal and written communication skills.
• Strong organizational and prioritization skills.
• Ability to manage multiple tasks and deadlines simultaneously.
• Exceptional time management skills.
• Strong interpersonal skills with the ability to work effectively across all levels of the organization.
• High degree of accuracy and attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Ability to maintain patient confidentiality and professionalism.
• May be responsible for performing basic clinical assessments.

Working Conditions

• Traditional clinical and office environment.
• Frequent exposure to conditions common in an oncology/hematology practice, including communicable diseases, toxic substances, ionizing radiation, and medical preparations.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions.
• Significant computer-based work.
• Frequent standing and walking throughout the clinic.
• Occasional lifting and carrying of items up to 40 pounds.
• Requires corrected vision and hearing within normal ranges.