Job description
Job Summary
General Summary
Leads the clinical research study process. Oversees collection, maintenance and retrieval of study data and implementing systems and procedures to ensure accuracy, consistency and conformance with protocol requirements. Acts as a resource to clinical research staff to ensure standards for data management and quality assurance are adhered to in each study.
Principal Duties and Responsibilities:
Knowledge and skills:
Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care 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
General Summary
Leads the clinical research study process. Oversees collection, maintenance and retrieval of study data and implementing systems and procedures to ensure accuracy, consistency and conformance with protocol requirements. Acts as a resource to clinical research staff to ensure standards for data management and quality assurance are adhered to in each study.
Principal Duties and Responsibilities:
- Oversees and coordinates daily operations of a study. Develops and implements systems and procedures to meet study goals and protocol requirements. Selects, trains and evaluates contract personnel in collaboration with Principal Investigator. Plans, assigns, prioritizes and supervises work of administrative and support personnel and consultants on contract related activities.
- Acts as a resource to clinical research staff to ensure standards for data management and quality assurance are adhered to in each study emergency, you may be asked to assume additional duties in other areas of the organization if needed.
- Monitors operations of research sub contract. Works with site personnel to develop and maintain systems for data collection and preparation of unit budget.
- Prepares, monitors and justifies project budgets according to hospital and funding agency specifications. Monitors expenses and identifies and resolves errors or discrepancies. Maintains financial records and prepares related reports.
- Communications project policies and procedures to contract and ancillary personnel at local study sites. Monitors and reviews data collection and computer entry, clinical testing, patient confidentiality and related activities to ensure compliance and consistency of application.
- Serves as liaison between local study sites and Clinical Coordinating Center regarding study procedures and operations and protocol interpretation. Ensures on site and subcontract operations are consistent with overall study requirements for database maintenance, coding, completion and computer input of study forms, deadlines and other related issues. Trains local study personnel in use of computer system.
- Supervises collection, coding and computer entry of study data. Conducts periodic testing of data validity, identifies and resolves any errors or discrepancies.
- Oversees development of computer applications and systems to enhance efficiency and effectiveness of study operations and data management, such as patient appointment scheduling, and completion and tracking of study data and forms.
- Assists Principal Investigator in preparing new applications for research funding and in developing, implementing, and managing ancillary study grants.
- Bachelors and 4 years of relevant experience or Masters of Science and 2 years of experience.
Knowledge and skills:
- 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.
Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care 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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