Senior Clinical Research Coordinator / Dana-Farber Cancer Center

South Shore Health•Weymouth, MA

12d•Onsite

About The Position

The Senior Clinical Research Coordinator works within the clinical research program to support the research team in conducting clinical trials according to Good Clinical Practice under the direction of the Principal Investigator and Clinical Research Manager. The role is responsible for primary data collection and management of patient clinical information related to trial participation, timely facilitation of protocol assessments, and collection and shipment of protocol-related samples. The coordinator maintains participant trial binders and may maintain regulatory binders and prepare IRB submissions to support compliance with state, federal, and IRB requirements. The role may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register participants in ONCORE. The Senior CRC oversees trial start-up, manages study data and records, coordinates clinical trials throughout their life cycle, and supports monitoring, auditing, and close-out activities. The position collaborates with internal departments, sponsors, regulatory authorities, and study participants. It also provides training and day-to-day direction to CRC I and II staff. Some travel may be required. This is an on-site, full-time position with a Monday-through-Friday schedule of 8:00 a.m. to 4:30 p.m.; hours may vary based on department needs.

Requirements

Bachelor’s degree preferred; one year of education is required.
Three to five years of experience in a medical or scientific research setting, or comparable technology-oriented business environment, preferred.
Excellent organizational and communication skills.
Strong interpersonal skills and ability to interact effectively with staff at all levels and external contacts.
Attention to detail and reliable follow-through.
Ability to manage time effectively and prioritize workload.
Ability to exercise discretion and comply with hospital confidentiality guidelines.
Computer skills, including use of Microsoft Office.
Understanding of ICH/GCP and federal regulatory requirements.
Understanding of DF/HCC standard operating procedures.
Comprehensive understanding of the roles and responsibilities of other clinical research departments, such as OHRS, ODQ, and CTO.
Ability to contribute to research protocol development and understanding of research design.
Ability to coordinate PI-initiated multicenter studies.
Responsibility for maintaining current knowledge and recognizing personal learning needs.

Nice To Haves

Bachelor’s degree.
Three to five years of experience in a medical or scientific research setting, or comparable technology-oriented business environment.

Responsibilities

Oversee clinical trial start-up, from protocol receipt through Scientific Review Committee and IRB submissions and site activation.
Manage data reporting and collection, source documents, case report forms, adverse event reporting, study-record filing and archiving, and resolution of data queries.
Prepare or complete regulatory reports and IRB submissions as needed; maintain participant and regulatory binders and enter required study data on an ongoing basis.
Ensure study samples are collected, prepared, and shipped according to protocol requirements and IATA/DOT regulations.
Collaborate with departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, and Research Nursing.
Organize and prepare for internal and external audits and study-monitoring visits.
Coordinate and manage clinical trials throughout their life cycle, including communication with sponsors and regulatory authorities.
Support clinical trial close-out, research articles, audit preparation, and communications with regulatory agencies and other involved disciplines.
Interact with study participants as required by the protocol or study team.
Collect tissue samples when required by trial protocols.
Enter Subject Visit Tracking information into the Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
Enter study-specific time and effort and other administrative tasks into the Clinical Trial Management System contemporaneously with work completed.
Enter study-specific activities, including monitor visits, external site enrollment, amendments, and receipt of safety reports, into the Clinical Trial Management System as they occur.
Orient and assist in training new staff.
Provide day-to-day work direction to CRC I and II staff and contribute input to development and corrective-action activities.
Support, train, and meet the educational needs of CRC I and II staff within the program.