Manager, Clinical Trials Education

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 Clinical Trials Education Manager reports to the Director of ODQ. The Clinical Trials Education Manager is responsible for supervising and overseeing the centralized clinical research educational activities and resources for research staff of the Dana-Farber/Harvard Cancer Center (DF/HCC). The cancer center is made up of the Boston-area, Harvard-affiliated institutions including: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, Boston Children’s Hospital, and Massachusetts General Hospital. Major responsibilities of the role including managing projects for and ensuring oversight over ODQ staff who coordinate the following activities: identifying educational needs for the consortium, production of educational materials and resources, conduct of live and online educational sessions, development and management of DF/HCC Policies and Operations, ODQ communications and website resources, and customer service for research staff and physician questions regarding DF/HCC policies and education requirements.

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.

Job Description

Primary Duties and Responsibilities

Chair the DF/HCC Education Subcommittee

• Identifying appropriate representatives from DF/HCC member institutions
• Managing committee meetings, agendas, and documentation
• Working with the committee to identify educational needs and opportunities, and develop education resources in response to those needs
• Oversight of education-related projects and delegation/distribution of project work amongst the committee members

Conduct of live educational activities for DF/HCC clinical research staff, including:

• Scheduling topics and speakers for DF/HCC live training sessions

• Recording and posting the training sessions for future viewing

• Overseeing staff who coordinate meeting logistics (location, AV requirements, etc.)

• Reporting metrics and statistics to the ODQ Director and senior DF/HCC leadership

Oversee the development, review, and approval process of the DF/HCC Policies and Operations, which includes the following:

• Management of the Clinical Research Operations Subcommittee (CLINOPS) operations and documentation, including approval of policy decisions
• Presenting feedback and recommendations from the research community and Education Subcommittee; recommending policy changes, and draft policy writing
• Distribution of draft policies for comment, collection of feedback, policy document cleanup and finalization and routing policies for approval sign off
• Maintaining version history of policies and operations
• Announcing policy changes to the DF/HCC community and posting revised policies and operations on the DF/HCC website
• Providing background or template training materials to institutional clinical trial offices to support implementation of policy changes

Developing and maintaining e-learning modules for DF/HCC required trainings and additional topics based on need.

• Designing, creating, recording, and updating e-learning modules for posting to the DF/HCC website.
• Ensuring training resources are updated with regulatory/policy changes.
• Identifying where additional modules are needed and promoting existing educational materials

Administration of the DFCI CITI training program account

• Management of the institutional CITI account

• Tracking completion of required CITI training and notifying research staff whose training has lapsed or is missing

Ensure compliance with investigator annual NCI registration requirements

• Oversight of ODQ staff who provide direct support to investigators with submitting registration materials in the NCI RCR system

• Responsible for tracking and reporting to leadership on compliance with registration requirements and deadlines; provide proactive notifications and reminders
• Escalate non-compliance to institutional clinical trials offices, institutional leaders, and CLINOPS as needed

Act as the face of ODQ for DF/HCC communications

• Sending broadcast announcements as needed, including for important updates, changes, and to promote educational resources

• Overseeing and curating ODQ’s online presence, resources, and educational materials on the DF/HCC website

• Ensuring excellence in customer service to investigators and study teams. Oversees staff who are responsible for email communications in the ODQ Education mailbox

Knowledge, Skills and Abilities:

• Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices.
• Prior experience in the conduct of clinical trials is required.

Minimum Job Qualifications:

• Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is preferred.
• 5 years’ experience in clinical trials; oncology experience preferred.
• 2 years’ experience supervising projects and/or staff.
• Knowledge of federal regulations and biologics regulations and/or experience in the conduct of clinical trials is required.

Supervisory Responsibilities:

This position will supervise 1-2 direct reports

Patient Contact:

No

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 committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate 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.

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).