Our research enterprise is the largest pediatric research program in the world, based on extramural research funding, characterized by innovation in the prevention, diagnosis and treatment of childhood disease as well as enhances the institution’s reputation in both science and pediatric healthcare. The Heart Center Clinical Research Program at Boston Children’s Hospital is seeking an experienced Clinical Research Manager to manage daily operations of clinical research studies supported by the Heart Center. A significant portion of this position will involve working as a member of two research teams:

Principal Duties and Responsibilities of the Clinical Research Manager II

• Leads and manages the work of multiple clinical research studies and/or multiple research sites.
• Collaborates and consults with Principal Investigators, study teams, and study stakeholders on the design, development, and conduct of clinical research studies and on clinical research best practices.
• Develops and oversees the implementation of best practice guidelines for various data collection methods including subject recruitment, chart reviews, subject interviews, and survey administration.
• Manages and trains research staff. Conducts the Performance Management process.
• Assists the principal investigator in developing study budgets. Works collaboratively with grant managers and other financial managers to monitor study budgets and prepare budget reports.
• Assists the principal investigator in preparing study progress reports and annual reports to study sponsor and the FDA.
• Works in collaboration with the Clinical Trials Business Office to prepare and execute site service agreements and material transfer agreements
• Manages regulatory submissions, including preparation of single IRB applications, Reliance Agreements, amendment submissions, and annual reporting.
• Designs and updates Manuals of Operation for research studies; Operations Memos, educational materials, and newsletters for communications with sites; and study materials for participants and families.
• Participates in conference calls and trial meetings, presentations and trainings as requested. Prepares agenda and minutes.
• Identifies, organizes, and ensures accurate completion and retention of required regulatory documents and other relevant files
• Establishes processes for clinical site monitoring and finalizes reports with site monitor.
• Collaborates with Heart Center investigators and Clinical Research Program scientific staff on writing research grants and study protocols.
• Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.

To qualify, you must have:

• A Bachelor’s degree and 8 years of relevant work experience or Masters of Science and 5 years of relevant work experience.

Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, childcare and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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