Clinical Research Coordinator, Adult Leukemia

About the Role

The Clinical Research Coordinator (CRC) will support the adult Leukemia clinical research program in the overall conduct of clinical trials under the Principal Investigator and the Clinical Research Manager, adhering to Good Clinical Practice.

Key Responsibilities

• Primary data collection and management of patient clinical information for clinical trial participation.
• Timely facilitation of trial assessments per protocol and collection/shipment of protocol-related samples.
• Support and maintenance of participant/subject trial binders and regulatory binders for study compliance.
• Potential responsibility for IRB protocol submissions.
• Screening patients for protocol eligibility.
• Obtaining informed consent for non-treatment trials.
• Registering study participants with the clinical trials management system, ONCORE.
• Oversight of the clinical trials start-up process from protocol receipt through Scientific Review Committee and IRB submissions, and site activation.
• Data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
• Preparation and completion of regulatory reports and IRB submissions.
• Maintaining and organizing study participant/subject trial binders and regulatory binders.
• Entering all required study data on an ongoing basis.
• Ensuring study-related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations.
• Collaboration with departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, and Research Nursing.
• Organizing and preparing for internal and external auditing and study monitoring visits.
• Coordination and management of clinical trials throughout their lifecycle, including communication with sponsors and regulatory authorities.
• Close-out of clinical trials, contributing to research articles, audit preparation, and communication with regulatory agencies.
• Interacting with study participants as directed by the protocol and/or study team.
• Potential tissue sample collection per trial requirements.
• Data entry of Subject Visit Tracking information into the Clinical Trial Management System contemporaneously with medical visits and assessments.
• Data entry of time and effort spent on study-specific activities and administrative tasks into the Clinical Trial Management System.
• Data entry of study-specific activities (e.g., monitor visits, external site enrollment, amendments, safety reports) into the Clinical Trial Management System.
• May have contact with Adult and Pediatric patients and may distribute protocol schedules, surveys, diaries, or conduct follow-up communication with patients.
• Some travel may be required.

Requirements & Tech Stack

• Good Clinical Practice
• ONCORE (Clinical Trials Management System)
• IATA/DOT regulations
• Microsoft Office
• Clinical Trial Management System

Qualifications

• Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience.
• 0-1 years of experience working in a medical or scientific research setting or comparable technology-oriented business environment preferred.
• Excellent organization and communications skills.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
• Detail-oriented with the ability to follow-through.
• Ability to effectively manage time and prioritize workload.
• Discretion and adherence to hospital confidentiality guidelines.
• Computer skills, including the use of Microsoft Office.