Clinical Trial Assistant Project Manager, CTTL Study Maintenance *Hybrid Remote

Job Description - Clinical Trial Assistant Project Manager, CTTL Study Maintenance Hybrid Remote (3303124)

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system.

Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care, and other health-related entities.

Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.

We’re focused on a people-first culture for our system’s patients and our professional family. That’s why we provide our employees with more ways to achieve their potential.

Mass General Brigham is committed to aligning our employees’ personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors.

We support each member of our team to own their personal development and we recognize success at every step.

Our employees use the Mass General Brigham values to govern decisions, actions, and behaviors. These values guide how we get our work done : Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk;

and how we treat each other : Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.

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 patients, 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 to 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 prepares 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 SOPs.
• 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 CTTL.
• Ensure 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.

EXPERIENCE : Required :

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.

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.

If you want to know about the requirements for this role, read on for all the relevant information.

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Remote working / work at home options are available for this role.