Job Description

Overview

The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, clinical trials education, and committee management. The Associate Director of Research Systems and Operations (ADRSO) supervises all Clinical Research Systems Specialists and reports to the Director of ODQ.

The Clinical Research Systems Specialist II (CRSS) ensures the accuracy of research data in the OnCore CTMS, performs centralized subject randomization for DF/HCC-initiated clinical trials, conducts feasibility reviews of new protocols, and facilitates activation of protocols and submissions in iRIS. Some Clinical Research Systems Specialists may be required to rotate coverage for after-hours patient care critical requests, as deemed necessary by the ADRS

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

Subject Registration

• Perform randomization and registration of clinical trial subjects for DF/HCC investigator-sponsored, randomized trials.
• Provide after-hours coverage for patient care critical registration issues (rotating schedule with other ODQ staff).
• Routinely review de-centralized subject registrations for data entry quality control. Ensure registrations are entered in accordance with DF/HCC policies, and that registrations successfully interface to downstream clinical systems, including COE, BOE, BICs, EMPI and InForm EDC.
  

OnCore CTMS Quality Control

• Review data in the OnCore CTMS for accuracy, completeness, and compliance with DF/HCC policies.
• Monitor OnCore QC reports and facilitate timely resolution of error flags.
• Track expiration of protocols and automatic closures in OnCore and update posted documents on OncPro, as necessary.

Facilitate the activation of new protocols, amendments and other submissions in iRIS.

• Perform a feasibility review of submissions to verify key operational components and compliance with DF/HCC policies (e.g., registration plan, data management plan, data safety monitoring plan, randomization schema, etc.).
• Facilitate activation of submissions by verifying readiness for activation, updating OnCore status information and formatting and posting final study documents.
• Create and post study-specific eligibility checklists when necessary.

Provide iRIS navigation assistance to research teams for high priority research studies.

• Receive, evaluate, and respond to requests for multiple parallel submissions or bundling of submissions in iRIS.
• Shephard these selected submissions through iRIS and coordinate with research teams, reviewers, and committees.
• Determine when it’s appropriate to manually override default system routing to facilitate activation of high priority submissions while ensuring all required regulatory and operational approvals are obtained.

• Assist in the training of new Clinical Research Systems Specialists on regulatory compliance issues, computer systems, policies and procedures.
  
• Participate in other ODQ special projects and activities as requested by the ADRSO

Qualifications

• Bachelor of Science or Bachelor of Arts with scientific specialty or other relevant major, or equivalent work experience..
• Familiarity with regulatory requirements and best practices related to the conduct of human subject research (e.g., FDA regulations, ICH GCP) is preferred.
• 2+ years of prior experience working in a medical or scientific research setting.
• Ability to communicate clearly and effectively with written and verbal English.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• In addition to the above, has progressed to have a more advanced understanding of connected research systems, clinical trial operations, and data points that impact patient safety.
• Able to provide input on work instructions and system changes.
• Demonstrated ability to review a protocol, comprehend the operational challenges involved, and suggest solutions.
• Ability to assist the Associate Director of Research Systems and Operations in training new specialists.

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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