Clinical Trial Assistant Project Manager - CTTL Research Activation **Hybrid Remote (massgeneralbrigham)

Job Description

Site: The General Hospital Corporation

 

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission—from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community.  We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.

 

 

Job Summary

Summary
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 and receivable as well as compliance and reconciliation related to the conduct of clinic trials. This position will also manage special projects as required.

Does this position require Patient Care?
No

Essential Functions
- Responsible for day-to-day operations of the Research Portfolio including coverage throughout the day, as well as vacations.
- Provides oversight for 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 SOP’s.
- 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.

 

Reporting to the Cellular Therapeutics and Transplantation (CTTL) Clinical Trial Project Manager, and the CTTL Medical Director, the incumbent provides comprehensive support for the CTTL Research Portfolio. The Clinical Trial Assistant Project Manager - CTTL 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.

Principle Duties and Responsibilities

Operations

• Responsible for day-to-day operations of the CTTL Research Portfolio including coverage throughout the day, as well as vacation cross coverage
• Provide first response for maintenance, personnel, and other research management issues
• Makes decisions and provides guidance relative to routine administrative and clerical matters.
• Provides guidance 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, 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 Activation

• Assist in the development and maintenance of CTTL clinical trial SOP’s
• Design and prepare clinical trial budgets pertaining to CTTL activation
• Submit budgets to the CCPO Financial Analyst to incorporate into overall study budgets
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• Coordinate investigator meetings and practice run-throughs for the CTTL
• Collaborate with other disease centers to assist in the creation of SOP’s for all new trials that involve the CTTL
• 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
• 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.
• Obtain and maintain study supplies and reagents

Administrative Responsibilities – Research Study Maintenance (Cross coverage required, as needed)

• 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 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

Knowledge, Skills and Abilities

• 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

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
No

Experience

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.
 

 

 

Hybrid

 

100 Blossom Street

 

40

 

Regular

 

Day (United States of America)

 

The General Hospital Corporation is an Affirmative Action 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 law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

 

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.