This Clinical Research Manager will manage daily operations of the Clinical Research Studies of Dr. Adrienne Randolph in Critical Care Medicine at Boston Children's Hospital focused on severe influenza and COVID-19 infections in children.
Develop and oversee the implementation of best practice guidelines for conducting various clinical research protocols.
Collaborate with PI and study stakeholders, including the Centers for Disease Control and Prevention and the National Institutes of Health, for management of research studies across multiple large pediatric hospitals.
Manage and train research staff and conduct Performance Management process.
Manage communication between study staff and internal /external stakeholders including up to 75 sites in the Pediatric Intensive Care Influenza and Emerging Pathogens (PICFLU-EP) Network (http://picflu.org) and the Overcoming COVID-19 Study ( https://overcomecovid.org ).
Assist in preparing and monitoring clinical laboratory and budgets, managing IRB and external site contracting, overseeing site training, development and management of the research database in REDCap, maintenance of equipment and ensures compliance with hospital and governmental regulations.
Ensure work is performed in conformance with established hospital, program, federal, and state policies and procedures.
Serve as a Clinical Research Study / Trial Manager for one or more large clinical studies overseeing the implementation of best practice guidelines for conducting various clinical research protocols.
Collaborate directly with PI and scientific staff on developing and writing grants and study protocols.
Work with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
Lead design and development of data management and data monitoring tools and procedures and supervises data management staff and activities in compliance with GCP and program standards
To qualify, you must have:
Work requires the knowledge of theories, principles, and concepts acquired through completion of a Bachelor's degree and a minimum of 8 years of relevant work experience or Master of Science and 4 years of relevant work experience.
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Work requires well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
Boston Children's Hospital offers competitive compensation and unmatched benefits.
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.