Clinical Trial Assistant Project Manager | Mgh Cancer Center - Hybrid Remote

Clinical Trial Assistant Project Manager | MGH Cancer Center - Hybrid Remote

Reporting to the Cellular Therapeutics and Transplantation (CTTL) Supervisor, and the CTTL Medical Director, the incumbent provides comprehensive support for the CTTL Research Portfolio. The Clinical Trial Assistant Project Manager - CTTL Study Maintenance / Study Activation works independently in a dynamic, fast-paced environment to ensure that the CTTL Research Portfolio workflow is run efficiently and effectively. Has a thorough understanding of the organization and functions of the CTTL. Organizes and tracks training and acts as a Cancer Center Protocol Office (CCPO) liaison for CTTL. This position is responsible for all accounts payable and receivable as well as compliance and reconciliation related to the conduct of clinic trials. This position will also manage special projects as required.

Position requires strong communication skills and has the ability to converse with patient, caregivers, professional and clinical staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Operations

• In collaboration with the Clinical Operations team, coordinates yearly mandatory training for all CTTL Technical Staff
• Provides administrative and clerical assistance for CCPO as needed.
• Responsible for day-to-day operations of the CTTL Research Portfolio including coverage throughout the day, as well as vacations.
• MediaLab Administrator for CTTL Research Training, develops/assigns courses, and schedule/runs reports.
• Provides oversight CTTL Technical Staff as primary resource for administrative/clerical issues and in relation to the CTTL Research Portfolio
• Responsible for maintenance of calendars, organizes meetings and filing system for the CTTL Research Portfolio. Uses independent judgment in setting priorities and proposing alternatives to meetings.
• Provides back-up coverage for the Clinical Trial Assistant Project Manager - CTTL Study Maintenance / Study Activation as applicable.
• Provide first response for maintenance, personnel, and other research management issues.
• Makes decisions and provides guidance relative to routine administrative and clerical matters.
• Responsible for all financial budgets related to CTTL Research Study Maintenance
• Maintains Departmental meeting minutes and distributes to staff as pertaining to the CTTL Research Portfolio
• Maintain calendars, organizes meetings, types and prepare documents, copies and distributes information as requested by Leadership.

Administrative Responsibilities – Research Study Activation

• Assist in the development and maintenance of CTTL clinical trial SOP’s.
• Work closely with the CCPO Financial Analyst to assure that all accounts receivables are current.
• Participate in clinical team meetings as it relates to the lab.
• Maintain and develop model and format for pricing study consumables.
• Manage special projects as assigned.
• Attend on-site investigator meetings.
• Collaborate with other disease centers to assist in the creation of SOP’s for all new trials that involve the CTTL.
• Coordinate investigator meetings and practice run-throughs for the CTTL
• Develop and maintain protocol specific binders and tools needed to ensure protocol compliance.
• Design and prepare clinical trial budgets pertaining to CTTL activation.
• Construct reports regarding the CTTL
• Review and maintain appropriate training records.
• Submit budgets to the CCPO Financial Analyst to incorporate into overall study budgets.
• Obtain and maintain study supplies and reagents.
• Work with the CCPO/PI to communicate all issues or concerns.

SKILLS & COMPETENCIES REQUIRED

• Proficient in Microsoft Office applications including Windows, Word, Excel, Access, Outlook
• Time management skills and ability to function effectively within a changing environment.
• Able to work independently, exercise discretion and maintain strict confidentiality.
• Team player with demonstrated ability to multi-task and manage competing priorities.
• Demonstrated writing and editing skills.
• Excellent interpersonal, communication and problem-solving skills along with attention to detail and follow-through
• Develop timelines and meet deadlines.

EXPERIENCE

• Demonstrated knowledge specific to the specialty.
• Bachelor’s degree in Biological Sciences or Medical Technology. Prior experience in a laboratory setting, cell processing and/or cryopreservation preferred.
• Demonstrated experience with cGMP procedures related to cellular therapies is desirable.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.