Clinical Research Coordinator II - Pediatric Oncology

Dana-Farber Cancer Institute is a cancer research and patient care organization committed to advancing treatment and providing comprehensive care. The Clinical Research Coordinator II will coordinate clinical trials, manage clinical and regulatory data, support participant interactions, collect and ship samples, and ensure compliance throughout the trial life cycle.

Responsibilities

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

May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable

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, as needed per the requirements of the clinical trial

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

May be responsible for tissue sample collection per trial requirements

Orients and assists in training new staff

May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients

Preferred

with a preference for those with a background in medical or scientific research or a technology-oriented business environment

Medical Research

Scientific Research

Technology Business

Benefits

Hybrid work arrangement: 2-3 days onsite per week

Company

Cancer treatment and research institute for children and adults

Boston, Massachusetts, USA

http://www.dana-farber.org/

Founded in 1947

1001-5000 employees

Qualifications

Excellent organization and communications skills required

Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts

Must be detail oriented

Ability to effectively manage time and prioritize workload

Must practice discretion and always adhere to hospital confidentiality guidelines

Must have computer skills including the use of Microsoft Office

The position requires a bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator

Candidates should have 1-3 years of relevant experience

With a preference for those with a background in medical or scientific research or a technology-oriented business environment

The position requires a bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator.

Required skills

Represents the skills you have, click on the tags

Experience

1-3 years