Job Information
Children's Hospital Boston Clinical Research Manager I in Boston, Massachusetts
74462BRJob Posting Title:Clinical Research Manager IDepartment:CardiologyAutoReqId:74462BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:Manages daily operations of the Clinical Research Studies. Develops and oversees the implementation of best practice guidelines for conducting various clinical research protocols. Collaborates with Principal Investigators and study stakeholders for management of research studies. Manages communication between study staff and internal and external stakeholders. Manages and trains the activities of research staff and conducts Performance Management process. Assist in preparing and monitoring clinical laboratory and budgets, maintenance of equipment and ensures compliance with hospital and governmental regulations.
Principal Duties and Responsibilities
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 collaborates with matrix team to design and develop study databases and related products and procedures.
Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.
Develops and oversees the implementation of best practice guidelines for maintaining quality improvement (QI) and research infrastructure, including: data management and data quality procedures; protocol development; staff education and training; regulatory compliance; and analysis file creation, statistical analyses, and report generation.
Management of registry, registry studies, and registry products.
Manages communication between study staff and internal and external stakeholders.
Develop and write grants and research protocols.
Hires, trains, and manages registry research staff and conducts Performance Management process.
As needed, develops and oversees program-specific on-boarding and ensures all staff complete required hospital training.
Prepares and monitors registry budget, maintains financial records of participating sites, and ensures compliance with hospital and governmental regulations.
Organizes and facilitates internal team meetings and external stakeholder meetings.
Ensures all work is performed in conformance with established program, hospital, state, and federal policies and procedures.
Requirements:
Bachelor's degree in STEM and 6 years relevant work experience or Master's degree and 4 years relevant experience.
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
Well-developed communication skills to provide critical information to study participants and collaborators, effectively deal with conflicting views or issues, and mediate fair solutions.
Advanced writing skills.
Boston Children’s Hospital offers competitive compensation and unmatched benefits.
Office/Site Location:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid