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

Massachusetts General Hospital; Boston (MA); Remote; USD 50,000 - 80,000; Full time

Job summary

An established industry player is looking for a Clinical Trial Assistant Project Manager to support their dynamic Research Portfolio. This role involves managing day-to-day operations, overseeing financial budgets, and ensuring compliance with clinical trial protocols. The ideal candidate will possess strong communication and problem-solving skills, thrive in a fast-paced environment, and be adept at multitasking. You'll play a crucial role in facilitating clinical trials, coordinating meetings, and maintaining essential documentation. If you're passionate about contributing to cutting-edge research in a collaborative setting, this opportunity is perfect for you.

Qualifications

• Bachelor's degree in a related field required.
• Prior experience in a laboratory setting preferred.

Responsibilities

• Manage day-to-day operations of the CTTL Research Portfolio.
• Assist in the development and maintenance of clinical trial SOPs.
• Coordinate investigator meetings and practice run-throughs.

Skills

Communication Skills

Problem-Solving Skills

Time Management

Attention to Detail

Education

Bachelor's Degree in Biological Sciences or Medical Technology

Tools

Microsoft Office Suite

Clinical Trial Database

Job description

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 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.

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 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 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 SOPs
• Design and prepare clinical trial budgets pertaining to CTTL activation.
• Submit budgets to the CCPO Financial Analyst to incorporate into overall study budgets.
• Coordinate investigator meetings and practice run-throughs for the CTTL
• Collaborate with other disease centers to assist in the creation of SOPs for all new trials involving the CTTL
• Work closely with the CCPO Financial Analyst to ensure 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 as needed)

• 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 for integration 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 ensure 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 to ensure protocol compliance.
• Attend on-site investigator meetings.
• Ensure 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 related to the lab.
• Review and maintain training records.
• Maintain accurate research files and procurement records.
• 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, 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 in a 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.

Experience with cGMP procedures related to cellular therapies is desirable.

The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, or other protected status under law.