Clinical Research Coordinator II

The Clinical Research Coordinator II (CRC II) will work within the Dana-Farber Foxborough Satellite 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(s) and the DFCI disease programs. The Satellite CRC will be responsible for the primary data collection, management of patient clinical information, and regulatory documents as it pertains to participation in clinical trials across all studies open at the Satellite site(s). Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains site regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for site IRB submissions (violations, deviations, severe adverse event reports). This individual may also screen patients for protocol eligibility, obtain informed consent (minimal risk studies), and register study participants to clinical trials. Travel to the Longwood campus and other DFCI Satellite sites may be required.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Oversight of the clinical trials regulatory process at the DFCI Satellite(s) and site activation activities
• Communication and coordination with the lead study team at the Longwood campus for study start-up, ongoing study team meetings, and project management of all site study activities
• Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s)
• Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the satellite?s studies. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
• Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits
• Coordination and management of all clinical trials at the Satellite site(s), 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 work
• Travel between DFCI satellite locations to support all above research activities when cross coverage is needed
• Maintain working knowledge of current regulations, regulatory guidance and or local policies
• May be responsible for preparing and presenting study status regulatory status for satellite site clinical team members at monthly research meetings

COMPETENCIES:

• Demonstrates understanding of CRF completion, including timely and accurate transcription of study data
• Shows an understanding in coordinating and managing clinical research studies
• Shows an understanding of ICH/GCP and Federal Regulatory requirements
• Shows an understanding of DF/HCC SOPs
• Shows an understanding of the roles and responsibilities of other key departments within clinical research (ex. OHRS, ODQ, DFCI CTO etc.)
• Proficient in understanding of phases of clinical trials
• Ability to work across satellite locations and provide on-site and remote support
• Is competent and autonomous with minimal assistance and supervision.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Excellent organization and communications skills
• Strong interpersonal skills with the 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

MINIMUM JOB QUALIFICATIONS:

The position requires a bachelor?s degree, with 1 to 3 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.

SUPERVISORY RESPONSIBILITIES:

Orients and assists in training new staff

PATIENT CONTACT:

Minimal patient contact.