Clinical Research Coordinator - GI Oncology

Dana-Farber Cancer Institute is hiring a Clinical Research Coordinator for its Gastrointestinal Oncology Clinical Research Program. The role supports the conduct and coordination of clinical trials, including patient clinical data management, regulatory compliance, sample collection, and participant-related activities.

Responsibilities

The Clinical Research Coordinator work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator

The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials

Ensures timely collection of protocol related samples including shipment to outside entities as required

Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements

May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols)

This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT)

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

Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information

Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed

Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed

Preferred

0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred

0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

Medical research experience

Scientific research experience

Technology business experience

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 and have the ability to follow-through

Ability to effectively manage time and prioritize workload

Must practice discretion and adhere to hospital confidentiality guidelines at all times

Must have computer skills including the use of Microsoft Office

Bachelor's Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required

0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred

Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required.

Required skills

Represents the skills you have, click on the tags

Preferred skills

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Experience

Entry level