Clinical Research Coordinator - Res G&C - Neely Center for Clinical Cancer Research

Principal Duties And Essential Functions

• Responsible for assisting in the recruitment of study participants.
• Affirms eligibility of potential patients based on protocol requirements.
• Reviews eligibility and ineligibility criteria in the patient's record.
• Verifies information with the physician and interviews patients for informed consent.
• Completes follow-up with study participants as required.
• Abstracts records and completes study Case Report Forms according to best practices.
• Conducts quality control checks on completed CRFs before submission for data entry.
• Coordinates resolution of data queries and performs data entry as needed.
• Maintains regulatory binders, case report forms, source documents, and other study materials.
• Maintains awareness of clinical adverse events and reports them to the PI, study sponsor, and IRB.
• Assists with IRB requirements including educational meetings, document submissions, and annual reviews.
• Performs basic laboratory activities as needed.
• Maintains patient confidentiality under HIPAA regulations.
• Adheres to FDA Good Clinical Practice Guidelines.
• Identifies and resolves protocol compliance issues by notifying the investigator and sponsor.
• Arranges necessary tests and procedures as per protocol requirements and reports results to the investigator.
• Participates in site visits with the study sponsor to review study documentation.
• Performs necessary tests as needed, within the scope of training, such as EKGs and walk tests.
• Maintains inventory of all study supplies.

Qualifications

• High degree of organizational talents, data collection, and analysis skills.
• Meticulous attention to detail.
• Excellent computer skills, including word processing.
• Ability to prioritize tasks quickly and appropriately.
• Excellent communication and interpersonal skills.
• Careful organization and systematic record-keeping.
• Education: Bachelor's degree or equivalent.
• Experience: 0-2 years in research-related activities.
• An equivalent combination of education and experience providing proficiency in responsibilities.
• Licenses, Certifications: BLS certification may be required based on specific role requirements.