Breast Oncology Trials Coordinator - Make an Impact

MFS Investments; Boston (MA); On-site; USD 48,000 - 54,000; Full time

Job summary

Dana-Farber Cancer Institute in Boston is seeking a Clinical Research Coordinator to oversee trial start-up, manage data and regulatory submissions, and ensure proper handling of samples. You will collaborate with multiple departments and support audits and trial close-out processes.

The role involves direct interaction with study participants, data entry into CTMS, and maintaining regulatory binders. Strong organizational and communication skills are essential.

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.

Responsibilities

• Oversight of the clinical trials start-up process from receipt of protocols through the SRC and IRB submissions, and site activation activities.
• 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.

Skills

Organizational skills

Interpersonal skills

Attention to detail

Time management

Discretion

MS Office

Education

Bachelor’s Degree

Dana-Farber Associate Clinical Research Coordinator experience

Job description

Dana-Farber Cancer Institute in Boston is seeking a Clinical Research Coordinator to oversee trial start-up, manage data and regulatory submissions, and ensure proper handling of samples. You will collaborate with multiple departments and support audits and trial close-out processes.

The role involves direct interaction with study participants, data entry into CTMS, and maintaining regulatory binders. Strong organizational and communication skills are essential.