Project Coordinator II - Medicine Clinical Trials Office

Mount Sinai Health System•New York, NY

About The Position

The Mount Sinai Department of Medicine Clinical Trials Office is looking for a Program Coordinator with experience in Clinical Trials Coordination and REDCap database management. This position is with Mount Sinai's Department of Medicine Clinical Trials Office (MCTO) and will report to the Research leadership. The ideal candidate will be responsible for managing start-up of multicenter trials and coordinating data collection activities for research studies using the REDCap platform. The Research Program Coordinator will also be responsible for completing special projects as needed to support the research team. Additional duties include operational assistance with other essential systems, as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the MCTO.

Requirements

Bachelors degree required, or equivalent education and work experience.
3 years of experience required
Ability to read research protocols to synthesize information and experience in clinical research study or trial management
Creative problem solving skills; ability to navigate through ambiguous situations.
Proven organizational skills including attention to detail and multi-tasking skills.
Must have a strong working knowledge of Microsoft Office Suite.
Training in GCP and HIPAA regulations will be required.
Bachelors Degree
3 years of research experience in coordination in healthcare or basic research.
Experience using REDCap for research data collection and management.
Knowledge of best practices for research data management, including data security, quality control, and ethical considerations.

Responsibilities

Coordinate and track startup activities (e.g., regulatory approvals, site activation, contracts, database readiness for multicenter clinical research studies across the lead site and participating sites.
Serve as a central point of communication for startup progress across sites.
Develop and update tracking tools, dashboards, and reports to communicate progress to stakeholders.
Track status of site contracts and budgets to ensure alignment with study timelines.
Review study protocols to understand required surveys/questionnaires and acquire necessary licenses/permissions for use of validated instruments.
Track database build progress, including development, testing, and deployment milestones.
Support monitoring of study activities across participating sites to ensure adherence to protocol and timelines.
Participate in or coordinate monitoring visits (remote or onsite) as needed.
Design, build, and maintain REDCap databases for research studies, including forms, surveys, workflows, user access controls.
Train research staff on the use of REDCap, including data entry, quality control, and reporting.
Monitor data quality and perform quality control checks to ensure accuracy and completeness of data.
Manage study participant data, including recruitment, informed consent, and tracking study progress.
Collaborate with study investigators and team members to design data collection strategies and protocols.
Provide technical support and troubleshooting for REDCap users, including identifying and resolving system issues and maintain up to date knowledge of REDCap functionality and best practices.
Prepare data summaries and reports for research team meetings and study investigators.
Ensure compliance with GCP, HIPAA, and institutional policies related to data security and research conduct.
Complete special projects as needed to support the research team, such as data cleaning and preparation, literature reviews, and contributing to grant proposals.