Clinical Research Assistant

Boston Children’s Hospital; Brookline, Northern (MA, KY); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Boston Children’s Hospital in Brookline, MA seeks a Clinical Trials Coordinator for Dermatology to coordinate daily activities of clinical trials and related studies. The role splits time between clinical trials and other research studies, focusing on screening, enrollment, protocol adherence, and data collection.

Responsibilities include obtaining informed consent, coordinating follow-up, preparing IRB-related documents, and assisting with study materials.

Qualifications

• Bachelor’s degree required.
• Prior clinical trial experience is desirable but not mandatory.

Responsibilities

• Consents and enrolls patients for research studies in Dermatology and explains study details.
• Acts as liaison to families/patients at on-site and off-site locations, guiding and supporting study participation.
• Coordinates IRB submissions and tracks progress from submission to approval.
• Assists in developing study documents and tracking enrollment information.
• May assist with manuscripts or reports to journals.
• Coordinates with departments to ensure proper testing/processing and clear instructions for participants.

Education

Bachelor’s Degree

Job description

Position Summary:

Under supervision, coordinates daily activities and operations of clinical trials and other research studies for the Division of Dermatology. Time will be split 50/50 between Clinical Trials and Other Research Studies. Responsible for screening and enrolling patients, monitoring protocol implementation, completing required forms and reporting results, and regulatory submissions. Conducts data collection activities and may prepare analytical reports on study results. Follows established clinical study standards and procedures to plan and conduct clinical research studies including clinical trials, retrospective chart reviews, and prospective survey studies. Maintain open communication with team members to ensure proper study progress.

Key Responsibilities:

• Consents and enrolls patients for research studies in Dermatology by providing detailed information on the Research Study to patients and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Obtains informed consent and enrolls patients in research studies. Reviews clinical information to identify patients meeting study inclusion criteria.
• Serves as liaison to the families/patients in the research studies, conducted at both on site and off-site locations, guiding and advising them throughout each phase of the study. Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots resolution of any issues that may arise throughout the study.
• Coordinates and prepares documentation needed for Institutional Review Board (IRB) on submissions, for PI approval. Tracks progress from submission to approval.
• Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study. Assist with the tracking and compilation of enrollment information.
• May assist with preparation of manuscripts and reports to be submitted to academic journals.
• May help train and orient newly hired study personnel.
• Coordinates activities with various departments to ensure correct testing/processing and sends clear instructions to each study participant. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.

Minimum Qualifications

Education:

• A Bachelor’s Degree is required.
• Prior clinical trial experience is highly desirable but not mandatory.