Clinical Research Coordinator II

About the Role

The Clinical Research Coordinator II, under the direction of the Principal Investigator (PI) or designee, independently performs delegated tasks and procedures involving human subject research. This includes coordination of regulatory activities and data collection/management for complex research protocols related to treatment, ancillary services, and prevention practices.

Responsibilities

• Obtain consent of research participants in accordance with IRB-approved protocols and all applicable regulations, including HIPAA.
• Identify, schedule, and/or conduct participant study visits, tests, and/or interviews/telephone follow-up calls.
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data.
• Conduct preliminary quality assurance reviews of study data.
• Assist with financial/operational aspects of grants and contracts, including clinical research billing review within the required timeframe.
• Present study status reports related to assigned research projects.
• Contribute to data presentations and Institutional Review Board (IRB) processes.
• Track and maintain study-related information in the data management system within the required timeframe.
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs.
• Contribute to the design, development, and documentation of study-related data and collection tools (e.g., questionnaires, treatment data, and/or therapeutic checklists).
• Monitor the inventory of research-related supplies.
• Document and collect data/samples for research-related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
• Monitor strict adherence to all study protocols, including regulatory requirements under federal, local, and institutional guidelines. Identify and resolve issues with protocol compliance.
• Comply with all safety and infection control standards appropriate to this position.
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices.
• Perform other duties as required.

Requirements

• Bachelor’s degree in a scientific or health-related field, or equivalent experience.
• 1–3 years of related experience.
• Ability to travel to off-site locations.

About the Projects

The CRC will work on multiple projects within the LEAD Lab at The Eunice Kennedy Shriver Center, UMass Chan Medical School, under the direction of Dr. Sarabeth Broder-Fingert and in collaboration with other faculty. This position includes work on NIH- and industry-sponsored research, supporting investigations using qualitative interviews with families and professionals as well as quantitative survey data. Projects focus on early development, early identification of children with developmental disabilities, and health systems/service access. The role involves cross-site collaboration and working closely with research partners at other institutions. Opportunities for research dissemination, including manuscript preparation and/or conference presentations, are available.

Preferred Qualifications

• Experience with database development and management.
• Experience with statistical data analysis.
• Comfortable interfacing with families, caregivers, and professionals in the context of recruitment and data collection.
• Demonstrated organizational skills and independent problem-solving.
• Interest in developmental disabilities and health equity.
• Proficiency in Spanish.