Details
Posted: 20-Jul-22
Location: Boston, Massachusetts
Type: Full Time
Required Education: 4 Year Degree
Sector:
Hospital, Public and Private
Additional Information:
2 openings available.
At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included.
Job SummaryOur research enterprise is the largest pediatric research program in the world, based on extramural research funding, and 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 (CRP) 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 the Data Coordinating Center (DCC) for an 18-site randomized clinical trial of pediatric patients supported with Extracorporeal Membrane Oxygenation (ECMO) to evaluate different red blood cell (RBC) transfusion strategies to improve clinical and neurodevelopmental outcomes.
The Clinical Research Manager II Responsibilities:
• 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 conducting various clinical research protocols.
• 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.
• 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 IRB applications, amendment submissions, and annual reporting.
• Manages communication between study staff and internal and external stakeholders.
• Manages and trains research staff. Conducts the Performance Management process.
• Collaborates with Heart Center investigators and CRP scientific staff on developing and writing grants and study protocols.
• Leads and collaborates with matrix team to design and develop study databases and related products including data management tools, standard operating procedures, and study manuals.
• Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.
Requirements:
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.
