Clinical Trial Assistant Project Management
Mass General Brigham • Somerville, MA6d • $63,253 - $102,596 • Hybrid
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Clinical Trial Assistant Project Management
Mass General Brigham•Somerville, MA
•$63,253 - $102,596•Hybrid
About The Position
The Clinical Trial Assistant Project Management position supports the Neurological Clinical Research Institute’s clinical research portfolio and clinical trial operations. The role manages multiple clinical trial sites throughout a trial, supports regulatory document review, advises research sites on protocol conduct, monitors data quality and timeliness, maintains trial databases, and helps resolve issues identified through monitoring and audits. The position works independently in a dynamic, fast-paced environment and may provide guidance and mentorship to other staff. The role also supports day-to-day Research Portfolio operations, organizes and tracks training, serves as a Protocol Office liaison, and handles administrative and financial responsibilities related to research study maintenance. These include managing budgets and budget amendments, processing invoices and journal entries, maintaining lab contracts, and obtaining study supplies and reagents. The position may manage special projects and assist with clinical trial SOPs. It can be hybrid or remote, with reliable internet access required; occasional onsite attendance may be required for meetings, sponsor audits, or regulatory inspections.
Requirements
- Bachelor’s degree in a related field of study, or experience in lieu of a degree may be accepted.
- Two to three years of previous industry clinical trial experience.
- Work independently in a dynamic, fast-paced environment.
- Have a thorough understanding of the organization and functions of the Research area.
- Reliable access to the internet.
Nice To Haves
- Two to three years of data management experience.
Responsibilities
- Manage multiple clinical trial sites for the duration of each trial.
- Collect and review essential regulatory documents for completeness before submission 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 clinical trial databases with current protocol versions and contact information, and generate reports from internal and external databases as needed.
- Work with department or trial managers to address issues identified through quality monitoring activities or audits.
- Prepare official trial correspondence, including numbered memos.
- Assist in training and developing 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 and serve 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.
- 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.
- Organize and track training and act as a Protocol Office liaison for the research area.
- Manage special projects as required and perform other duties as assigned.
- Comply with applicable policies and standards.
Benefits
- Competitive base pay.
- Career advancement opportunities.
- Differentials, premiums, and bonuses as applicable.
- Recognition programs.
- Comprehensive benefits package; specific benefits are not detailed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
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