Job Description

Overview

The Clinical Research Coordinator will support the Breast Oncology Center's Inflammatory Breast Cancer (IBC) Studies Program and its research in the areas of screening, recruitment, data collection, assurance of high-quality data, biospecimen collection and database organization. This position will report directly to the Medical Director, Inflammatory Breast Center. Duties include the examination, synthesis, and evaluation of medical records for screening and tracking of patients for banking and therapeutic studies and the collection of biospecimens, including archival tissue and serial blood samples with direction and guidance from the Medical Director of IBC, and the Director, Associate Director, and Clinical Research Manager of the overall Cohort Studies Program. This position will screen patients for protocol eligibility, obtain informed consent, and register study participants to IBC related cohort and banking studies. 

The Dana-Farber Inflammatory Breast Cancer Program has been in existence since 2010 and has successfully developed and maintained three IRB approved retrospective clinical registries to facilitate the investigation of IBC that house more than 600 patients. Since its inception, the DFCI Inflammatory Breast Cancer Program has utilized the information obtained from these active databases and biobank to investigate various questions including: the impact of locoregional treatment in metastatic IBC, incidence of CNS metastasis in IBC, prevalence of pathogenic germline variants in IBC, the impact of pathologic complete response to preoperative systemic therapy among all subtypes of IBC, and the metabolic characterization of IBC using PET-imaging. In addition, these registries have provided extensive information concerning the biology and epidemiology of IBC, allowing for investigation and presentation at national and international scientific meetings.

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

• Screen patients for protocol eligibility, obtain informed consent, and register study participants to cohort studies.
• Interact with study participants as directed/required by the protocol and/or study team.
• 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.
• Review and abstract clinical information from medical records for patients into departmental databases upon study enrollment and follow-up.   
• Verify data for quality and completeness for preparation for analyses.  
• Collaborate with other RDS/CRC, project managers, principal investigators, analyst programmers and other investigators/external collaborators in translational and other research studies. 
• Assist principal investigators and study team in the creation of lists of patients and samples for study management and analyses that may include various data sources such as departmental databases (e.g. REDCap), OnCore, and OpenSpecimen and interfaces with OncDRS. 
• Assist principal investigators and study team in the collection of additional clinical data for specific research studies when needed. 
• May assist study team with other research-related tasks such as: retrieval, labelling, and other preparation of the collation of biological specimens; regulatory needs such as User Committee proposals, IRB applications, amendments and continuing reviews.
• Orients and assists in training new staff.

Qualifications

• Bachelor’s Degree and 1-3 years of equivalent experience required.
• 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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