Clinical Trial Assistant Project Management

Mass General Brigham•Somerville, MA

2d•$63,253 - $102,596•Hybrid

About The Position

The Clinical Trial Assistant Project Management role supports clinical trial operations and research portfolio workflow at the Neurological Clinical Research Institute, an academic research organization within Massachusetts General Hospital. The position manages multiple clinical trial sites, works independently in a dynamic, fast-paced environment, and helps ensure research operations run efficiently and effectively. It also provides guidance and mentorship to staff on trial operations and supports training, process improvements, regulatory documentation, data quality, budgets, and administrative functions. The role may be hybrid or remote, with reliable internet access required; occasional onsite attendance may be requested for meetings, sponsor audits, or regulatory inspections. The position is responsible for day-to-day operations of the Research Portfolio, including coverage throughout the day and during vacations, administrative support for technical staff, financial budgets and budget amendments related to Research Study Maintenance, invoices and payment journal entries, study supplies and reagents, and lab contracts. It also assists with clinical trial SOPs, maintains trial databases, handles trial correspondence and reporting, and addresses issues identified through quality monitoring or audits.

Requirements

Bachelor's degree in a related field of study, or relevant experience in lieu of a degree may be accepted.
Previous industry clinical trial experience of 2–3 years.
Work independently in a dynamic, fast-paced environment.
Thorough understanding of the organization and functions of the Research area.
Reliable access to the internet.
Occasional onsite attendance may be required for meetings, sponsor audits, or regulatory inspections.

Nice To Haves

Data management experience of 2–3 years is preferred.

Responsibilities

Manage multiple clinical trial sites for the duration of each trial.
Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review or approval.
Advise research sites on protocol conduct and interpretation, and ensure issues are resolved.
Evaluate the quality and timeliness of data entry; issue, track, and resolve queries; and implement corrective action plans as needed.
Maintain clinical trial databases containing the latest protocol versions and updated contact information.
Work with department or trial managers to address issues identified through periodic quality monitoring activities or audits.
Prepare official trial correspondence, including numbered memos; develop and maintain databases; and generate reports from internal and external databases as needed.
Assist with training and developing junior staff in key processes and procedures.
Ensure efficient day-to-day Research Portfolio operations, including coverage throughout the day and during vacations.
Provide oversight to technical staff as the primary resource for administrative and clerical issues.
Manage financial budgets related to Research Study Maintenance.
Assist in developing and maintaining clinical trial standard operating procedures.
Design and prepare clinical trial budget amendments pertaining to Research Study Maintenance.
Track outside invoices and submit journal entries for payment.
Obtain and maintain study supplies and reagents.
Maintain, monitor, and renew lab contracts.
Organize and track training and act as a Protocol Office liaison for the research area.
Perform other duties as assigned and comply with applicable policies and standards.