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- Leads and manages the work of multiple clinical research projects.
- Serves as Clinical Research Study / Trial Manager for one or more large, clinical studies.
- Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies and on clinical research best practices.
- Works with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
- Collaborates directly with Hospital investigators and CRP scientific staff on developing and writing grants and study protocols.
- Develops curriculum, conducts lectures, and directs courses as part of sponsored educational efforts to train clinical investigators and study staff in clinical research regulations and best practices.
- Leads 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.
- Lead and collaborate with matrix team to design and develop study databases and related products and procedures.
- Manages Staff's Performance Reviews.
- Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.
- Must have a minimum of a Bachelor's Degree and a minimum of 6 years of relevant experience or a Master's Degree and 4 years of relevant experience.
- Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
- 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.
- Advanced writing skills.
Clinical Research Manager I- Division of Immunology/Allergy - Boston, United States - Boston Children's Hospital
Description
Job Posting DescriptionThe Boston Children's Hospital Division of Immunology/Allergy is seeking a full-time, long-term Clinical Trial Manager for a busy NIH-funded Asthma/Allergy Clinical Research Center leading state-of-the-art studies on asthma and allergic diseases and interacting with multiple Centers across the country, the NIH, and the FDA. The program conducts state-of-the-art pediatric clinical trials with up to 13 national sites and a centralized Data Coordinating Center. The center also conducts community-focused studies focused on mechanisms and environmental interventions to reduce health disparities.
This Clinical Research Manager I will be responsible for:
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