Under direction of the Principal Investigator and/or designee, independently carries out studies. Responsible for screening patients for trial participation, enrolling patients, monitoring protocol implementation, completing required forms, reporting results and regulatory submission. Creates study-specific data collection and statistical and analytical reports. Responsible for managing and coordinating the clinical studies as members of the research team and will work closely with multidisciplinary teams and participate in subject research activities throughout the studies. May assist in writing articles and summarizing papers for submission.

Key Responsibilities

• Responsible for daily operations of the study. Implements processes and procedures to meet study goals and protocol requirements. May participate in training Clinical Research Assistants and prepare study related training materials as needed in collaboration with the Principal Investigator and/or designee.
• Consents and enrolls patients for studies by providing detailed information on the clinical study to prospective participants and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Evaluates the suitability of study candidates and makes selections based on clinical knowledge of each study.
• Provides input for updates of SOPs and drafting of new quality documentation. Coordinates and prepares with minimal supervision the necessary documentation for Institutional Review Board (IRB) and external stakeholders on submissions and track progress to review and approval. May prepare, monitor, and justify project budgets according to hospital and funding agency specifications. Monitors expenses and identifies and resolves errors or discrepancies. May maintain financial records and prepare related reports.
• For multi-center studies, performs subrecipient monitoring to ensure timely invoicing and progress according to schedule. 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. Maintains regulatory binders and all study documentation, monitors adverse events and reporting thereof, handles protocol amendments.
• Creates tracking systems and assist with developing processes 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. Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis.
• May write articles and summaries of studies for submission. May present study results at local and national meetings. Assists Principal Investigator in preparing new applications for research funding and in developing, implementing, and managing ancillary study grants. Assists in preparing scientific abstracts and manuscripts for publication in academic journals.

Minimum Requirements
Education

• Bachelors Degree

Experience

• 2 years of relevant experience
• Ability to proofread and check documents for accuracy.
• Ability to input and retrieve words or data into or from an automated/computer system.

Boston Children’s Hospital offers competitive compensation and unmatched benefits.