Job Description

Overview

Dana-Farber’s Division of Population Sciences is seeking a Clinical Research Coordinator II to support a multidisciplinary, multi-center implementation project designed to improve participation of underrepresented patients in blood cancer research across the Dana-Farber network. Building on extensive institutional efforts to expand access to clinical trials, this role will coordinate complementary research interventions; manage day-to-day study operations; and collaborate closely with research navigators, clinicians, scientists, patients, and administrative stakeholders, including OnCore Data Informatics team and Office for Human Research Studies (OHRS).

The CRC II will report directly to the Principal Investigator and contribute to aligned research evaluating barriers in the delivery of cancer research and testing solutions to address them. This is an excellent opportunity for a self-motivated coordinator to help grow a high-impact research enterprise with opportunities to contribute to publications.

This position’s work location is onsite, full-time at our Boston campus.

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.
• 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.

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 in working with study participants.
• 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, 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.

Qualifications

• Bachelor’s Degree or 2 years of Dana-Farber Clinical Research Coordinator experience required.
• 1-3 years of equivalent experience required.  
• Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.   
• Knowledge of regulatory affairs, research ethics, and the responsible conduct of research preferred.
• Bilingual in Spanish, Portuguese, Chinese, or Haitian Creole preferred.

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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