Job Description

Overview

These positions 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(s) and the DFCI Clinical Trials Office. 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 to clinical trials. . Some travel 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.

Responsibilities

• 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.
• Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
• 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 clinical trials, 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.
• Orients and assists in training new staff.

SUPERVISORY RESPONSIBILITIES:

Orients and assists in training new staff.

Qualifications

• Bachelor’s Degree and 1-3 years of equivalent experience required.
• Bilingual Spanish or Mandarin preferred.
• Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

COMPETENCIES:

• Demonstrates understanding of CRF completion, including timely and accurate transcription of study data
• Shows an understanding in setting up, 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, QACT, CTO etc.)
• Proficient in understanding of phases of clinical trials
• Ability to coordinate PI initiated studies
• Is competent and autonomous with minimal assistance and supervision.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• 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

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.  As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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