Clinical Research Coordinator

Boston Children's Hospital; Boston (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Boston Children’s Hospital seeks a Clinical Research professional to independently carry out studies under the Principal Investigator. The role involves screening and enrolling patients, monitoring protocol adherence, and preparing regulatory submissions and data reports.

Collaboration with multidisciplinary teams and participation in subject research activities are integral. Opportunities to assist in writing articles and manuscripts for publication are available.

Qualifications

• Bachelor's degree in a science field is required.
• 2 years of relevant and applicable experience required.

Responsibilities

• Oversee daily operations of the study and ensure protocol adherence.
• Screen and enroll patients for studies; provide detailed information to prospective participants and families.
• Prepare regulatory submissions and maintain regulatory binders and study documentation.
• Monitor study progress, track budgets, and prepare related reports.
• Coordinate with local sites and Clinical Coordinating Center on procedures and operations.
• Develop data collection systems and generate statistical reports and summaries for review.

Skills

Data collection

Regulatory submissions

IRB coordination

Budget monitoring

Study coordination

Education

Bachelor's degree in a science field

Job description

Position Summary

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.

Position Summary

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 Qualifications

Education

• A bachelor's degree in a science field

Experience

• 2 years of relevant and applicable experience

The posted pay range is Boston Children’s reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes 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.