Clinical Research Coordinator III

About the Job

The Clinical Research Coordinator III is responsible for providing technical expertise and overall management of clinical research data collection, study documentation, protocol-required
procedure execution, and collaboration with PI and study team to ensure consistent and accurate implementation of the protocol. The incumbent will be expected to follow Good Clinical
Practice (GCP) and all organization policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.

SPECIFIC RESPONSIBILITIES
Trial Management / Study Coordination (60%)
● Interprets protocols and creates source documents needed for clinical research study
● Identifies and reports protocol deviations within the required timeline in accordance with institutional requirements
● Ensures protocol adherence by communicating and ensuring study parameters are executed according to protocol
● Oversees visits with outside sponsors, including site initiation visits, interim monitoring visits and closeout visits
● Collaborates with PI and study team to enroll study participants, execute study-required procedures, and maintain accurate source documentation
● Maintains a processing and tracking system for protocol-required biospecimens, data, and procedures
● Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down, and laterally
● Troubleshoots problems in the development and implementation of protocol procedures
● Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other bodies across campus to deliver drug, collect biospecimens, and execute the study visits according to protocol

Data Management (25%)
● Serves as primary contact for the collection and completion of required study documentation
● Develops and maintains study documentation to ensure audit-proof compliance
● Abstracts data from medical record to ensure accurate and complete source documentation
● Manages electronic data capture systems, including but not limited to building the case report forms, responding to queries, and meeting data lock deadlines
● Demonstrates proficiency with Common Terminology Criteria for Adverse Events (CTCAE), medical terminology, critical lab values, and other disease-specific diagnostic criteria

Lead Activities (15%)
● Mentors and trains new staff, providing task level guidance to CRCs I and II
● Serves as subject matter experts in key CTO processes
● Manages additional workload during staff changes

Qualifications

REQUIRED QUALIFICATIONS
● BA/BS with at least 4 years of experiences or an advanced degree and 2 years of experience or 8 years of relevant education & healthcare or research experience
● Oncology experience in a clinical or research setting
● Excellent attention to detail and organizational skills
● Ability to work independently, as part of a team, and with changing priorities
● Computer proficiency in a PC environment including Microsoft Office products
● Ability to sit for extended periods of time

PREFERRED QUALIFICATIONS
● Clinical Research Coordinator certification or equivalent
● Experience with disease-specific research or clinical care
● Experience with patient contact / care
● Experience abstracting clinical data and familiarity with medical terminology
● Experience with Epic, Oncore, or equivalent medical record / Clinical Trial Management Systems

Pay and Benefits

Pay Range: $65,000 - $70,000; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type:Civil-Service & Non-Faculty Labor Represented Staff