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General Summary:
Reporting to Cellular Therapeutics and Transplantation (CTTL) leadership, 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
Responsible for day-to-day operations of the CTTL Research Portfolio including coverage throughout the day, as well as vacations
Provide first response for maintenance, personnel, and other research management issues
Makes decisions and provides guidance relative to routine administrative and clerical matters.
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.
Provides administrative and clerical assistance for CCPO as needed.
Maintain calendars, organizes meetings, types and prepare documents, copies and distributes information as requested by Leadership
Maintains Departmental meeting minutes and distributes to staff as pertaining to the CTTL Research Portfolio
Responsible for all financial budgets related to CTTL Research Study Maintenance
MediaLab Administrator for CTTL Research Training, develops/assigns courses, and schedule/runs reports
In collaboration with the Clinical Operations team, coordinates yearly mandatory training for all CTTL Technical Staff
Administrative Responsibilities - Research Study Maintenance
Assist in the development and maintenance of CTTL clinical trial SOP's
Maintain clinical trial database that includes latest protocol versions and updated contact information.
Design and prepare clinical trial budget amendments pertaining to CTTL Research Study Maintenance
Submit CTTL Invoicing to the CCPO Financial Analyst to incorporate into overall study budgets
Coordinate investigator meetings and practice run-throughs for the CTTLEnsure all Manuals and SOPs are current and updated for all new trial amendments
Work closely with the CCPO Financial Analyst to assure that all accounts receivables are current
Manage special projects as assigned
Work with the CCPO/PI to communicate all issues or concerns
Develop and maintain protocol specific binders and tools needed to ensure protocol compliance
Attend on-site investigator meetings
Assure any protocol amendments are communicated with lab personnel
Maintain and develop model and format for pricing study consumables
Construct reports regarding the CTTL
Participate in clinical team meetings as it relates to the lab
Review and maintain appropriate training records.
Maintain accurate research files and records of procurement
Monitor the CTTL cost center and submit encounter forms for revenue processing
Track outside invoices and submit journal entries for payment
Obtain and maintain study supplies and reagents
Maintain, monitor and renew lab contracts
SKILLS & COMPETENCIES REQUIRED:
Demonstrated writing and editing skills
Proficient in Microsoft Office applications including Windows, Word, Excel, Access, Outlook
Excellent interpersonal, communication and problem-solving skills along with attention to detail and follow-through
Team player with demonstrated ability to multi-task and manage competing priorities
Able to work independently, exercise discretion and maintain strict confidentiality
Time management skills and ability to function effectively within a changing environment
Develop timelines and meet deadlines
WORKING CONDITIONS:
Normal office conditions apply
May require manipulation of common office objects and materials
Qualifications
EXPERIENCE:
Required:
Bachelor's degree.
Preferred:
Bachelor's degree in Biological Sciences or Medical Technology. Prior experience in a laboratory setting, cell processing and/or cryopreservation preferred.
Demonstrated knowledge specific to the specialty.
Demonstrated experience with cGMP procedures related to cellular therapies is desirable.
EEO Statement
Mass General Brigham is an Equal Opportunity Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under the law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.