Clinical Trial Assistant Project Management

massgeneralbrigham; Somerville (MA); Híbrido; USD 57.000 - 70.000; Jornada completa

Descripción de la vacante

The General Hospital Corporation (Mass General Brigham NCRI) in Somerville, MA is seeking a Clinical Trial Assistant Project Manager (Systems use) to oversee multiple trial sites and support protocol operations. You will train staff, manage data and budgets, and ensure regulatory compliance across the Research Portfolio.

This role can be hybrid or remote, with on-site duties at 399 Revolution Drive and collaboration with trial managers to address quality and audits.

Formación

• Bachelor's Degree required
• Related Field of Study required
• Can this role accept experience in lieu of a degree? Yes

Responsabilidades

• Manage multiple clinical trial sites for the duration of the trial.
• Collect and review essential regulatory documents for submission to Regulatory for review/approval.
• Advise research sites on protocol conduct and interpretation and resolve issues.
• Evaluate data entry quality and resolve queries; implement corrective actions.
• Maintain a clinical trial database with latest protocol versions and contacts.
• Coordinate with department/trial managers to address quality monitoring findings and audits.
• Prepare trial correspondence and develop/maintain databases; generate reports.

Educación

Bachelor's Degree

Related Field of Study

Experience in lieu of degree

Descripción del empleo

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.

Does this position require Patient Care? No

Essential Functions

• -Manage multiple clinical trial sites for the duration of the trial.
• -Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval.
• -Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues.
• -Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.
• -Maintain a clinical trial database that includes the latest protocol versions and updated contact information.
• -Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
• -Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
• -Assist in the training and development of other junior staff members in key processes and procedures.
• -Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits

The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses,quality specialists and administrative assistants dedicated to planning and implementing clinical trials.

Works independently in a dynamic, fast-paced environment to ensure that the Research Portfolio workflow is run efficiently and effectively. Has a thorough understanding of the organization and functions of the Research area. Organizes and tracks training and acts as a Protocol Office liaison for the research area. This position is responsible for all accounts payable andreceivable as well as compliance and reconciliation related to the conduct of clinical trials. This position will also manage special projects as required.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Responsible for day-to-day operations of the Research Portfolio including coverage throughout the day, as well as vacations
• Provides oversight Technical Staff as primary resource for administrative/clerical issues.
• Responsible for all financial budgets related to Research Study Maintenance.
• Assist in the development and maintenance of clinical trial SOPs.
• Maintain clinical trial database that includes latest protocol versions and updated contact information.
• 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.
• Performs other duties as assigned.
• Complies with all policies and standards

EDUCATION

• Bachelor's Degree
• Related Field of Study required
• Can this role accept experience in lieu of a degree? Yes

EXPERIENCE

• Previous Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred

FISCAL RESPONSIBILITY

• All financial budgets related to Research Study Maintenance.
• Design and prepare clinical trial budget amendments pertaining to Research Study Maintenance
• Track outside invoices and submit journal entries for payment
• Maintain monitor and renew lab contracts

This position can be either hybrid or remote. Must have reliable access to internet. On occasion and at the discretion of the Director of QA the Clinical Trial Assistant Project Manager (Systems use) may be required to be onsite for meetings, sponsor audits or regulatory inspections. Advanced notice will be given.

Additional Job Details (if applicable)

• Remote Type
• Hybrid
• Work Location
• 399 Revolution Drive
• Scheduled Weekly Hours
• 40
• Employee Type
• Regular
• Work Shift
• Day (United States of America)
• Pay Range
• $63,252.80 -