Research Coordinator

Overview

Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.

Responsibilities

• Demonstrate understanding of the protocol elements and requirements.
• Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial.
• Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
• Screen, recruit, enroll prospective patients using EMR, EDC, CTMS.
• Create and maintain enrollment logs for each trial from beginning to end.
• Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
• Collaborate with the cross-functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistants, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
• Oversee study kits, study drug accountability records, study kits / IMP drug destruction and maintenance.
• Enter all data into EDC and EMR within 24 hours of data collection.
• Communicate and resolve all data queries within 5 days.
• Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to the PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
• Assist the regulatory coordinator in collecting all necessary regulatory documents (CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug storage for specimens, temperature logs, and other required essential documents).
• Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
• Provide timely and complete updates to study team members regarding changes to workflow or patient-related needs by the protocol or SOP.
• Monitor all clinical logistics including infusion chair assignments and EMR workflow to ensure alignment with protocol requirements.
• Interact with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and study-related issues.
• Support internal and external audits.
• Take initiative to resolve protocol-related concerns and discrepancies; generate solutions to barriers and opportunities for improvements.
• Centrifuge, process, prepare, ship, and store biological materials by sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
• Conduct weekly and monthly clinical trial meetings within the division.
• Attend SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings as required.
• Track and submit clinical trial patient reimbursements.
• Other duties as assigned.

Qualifications

Working Conditions

Job Details

J-18808-Ljbffr