Senior Clinical Research Coordinator / Dana-Farber Cancer Center

Job Description Summary The Senior CRC (Clinical Research Coordinators) 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 and the Clinical Research Manager. The Senior 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 facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required. Job Description The following competencies are necessary to qualify for the Senior CRC role: Supports, trains and meets the educational needs of CRCs I and II within the program. Articulates understanding of ICH/GCP and Federal Regulatory requirements. Articulates understanding of DF/HCC SOPs Has a comprehensive understanding of the roles and responsibilities of other departments within clinical research (ex. OHRS, ODQ, CTO etc.) Contributes to the development of research protocols and understands research design. Ability to coordinate PI initiated multi-center studies. Recognizes own learning needs and takes responsibility for maintaining up to date knowledge.

ESSENTIAL FUNCTIONS

1. Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
2. 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.
3. 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.
4. Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.
5. 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.
6. Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
7. Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.
8. Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
9. Interact with study participants as directed/required by the protocol and/or study team.
10. May be responsible for tissue sample collection per trial requirements.
11. Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
12. 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.
13. 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.
14. Orients and assists in training new staff.
15. Provides day-to-day work direction to CRC I and II. Provides input as needed for development and corrective action activities.

JOB REQUIREMENTS

Minimum Education - Preferred Bachelor’s Degree or 1 year required. Minimum Work Experience 3-5 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Required additional Knowledge and Abilities 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. #J-18808-Ljbffr South Shore Health