Clinical Research Coordinator II - Precision Medicine

• liaise between the LSP, DF/HCC hospitals, and external investigators to facilitate highly collaborative translational biomarker driven research
• facilitate the emerging fields of cancer spatial biology
• work closely with principal investigators, program managers, biomarker researchers, and data scientists
• primary data collection and management of patient clinical information as it pertains to participation in clinical trials and patient consent
• ensure timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities
• support and maintain participant/subject trial binders and maintain regulatory binders
• ensure study compliance with all state, federal, and IRB requirements
• screen patients for protocol eligibility
• obtain informed consent for non-treatment trials
• register study participants with the clinical trials management system, ONCORE
• oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities
• responsible for 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
• prepare and or complete regulatory related reports and IRB submissions
• ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations
• collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments
• responsible for organizing and preparing for both internal and external auditing and study monitoring visits
• coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities
• close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved
• interact with study participants as directed/required by the protocol and/or study team
• be responsible for tissue sample collection per trial requirements
• travel may be required

• bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator
• 1-3 years of relevant experience
• preference for those with a background in medical or scientific research or a technology-oriented business environment
• excellent organization and communications skills
• strong interpersonal skills
• detail oriented
• ability to effectively manage time and prioritize workload
• must practice discretion and adhere to hospital confidentiality guidelines
• computer skills including the use of Microsoft Office

background in medical or scientific research or a technology-oriented business environment