Clinical Trial Assistant Project Management

Mass General Brigham•Somerville, MA

1d•Hybrid

About The Position

The Clinical Trial Assistant Project Management role supports the Neurological Clinical Research Institute’s clinical trial and research portfolio operations. The position works with a high degree of independence, understands trial protocol requirements, contributes to process improvements, and provides guidance and mentorship to junior staff. It helps ensure that research portfolio workflows operate efficiently, organizes and tracks training, and serves as a Protocol Office liaison for the research area. The role also manages special projects as needed and is responsible for financial budgets, accounts payable and receivable, and compliance and reconciliation related to clinical trial conduct. The position may be hybrid or remote and requires reliable internet access. Occasional onsite attendance may be required, at the Director of QA’s discretion, for meetings, sponsor audits, or regulatory inspections; advance notice will be provided. The role is based at 399 Revolution Drive and is scheduled for 40 hours per week on the day shift.

Requirements

Bachelor’s degree in a related field; equivalent experience may be accepted in lieu of a degree.
2–3 years of previous industry clinical trial experience.
Reliable access to the internet.
Ability to work independently in a dynamic, fast-paced environment and support efficient research portfolio workflows.

Nice To Haves

2–3 years of data management experience.

Responsibilities

Manage multiple clinical trial sites throughout the duration of trials.
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 data-entry quality and timeliness; issue, track, and resolve queries; and implement corrective action plans as needed.
Maintain a clinical trial database with current protocol versions and contact information.
Work with department or trial managers to address issues identified through periodic quality monitoring 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 development of junior staff in key processes and procedures.
Support day-to-day Research Portfolio operations, including coverage throughout the day and during vacations.
Provide oversight to technical staff as a 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 (SOPs).
Design and prepare clinical trial budget amendments related 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.
Perform other duties as assigned and comply with organizational policies and standards.