Clinical Trial Assistant Project Management

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

Summary
Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.

Does this position require Patient Care?
No

Essential Functions
-Manage multiple clinical trial sites for the duration of the trial.

-Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval.

-Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues.

-Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.

-Maintain a clinical trial database that includes the latest protocol versions and updated contact information.

-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.

-Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.

-Assist in the training and development of other junior staff members in key processes and procedures.

-Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits

Qualifications

The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses,

quality specialists and administrative assistants dedicated to planning and implementing clinical trials.

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 clinical trials. This position will also manage special projects as required.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Relevant activities include, but are not limited to the following:

- Responsible for day-to-day operations of the Research Portfolio including coverage throughout the day, as well as vacations

- Provides oversight 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.

- Performs other duties as assigned.

- Complies with all policies and standards

EDUCATION:

Bachelor's Degree

Related Field of Study required

Can this role accept experience in lieu of a degree? Yes

EXPERIENCE:

Previous Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred

FISCAL RESPONSIBILITY:

All financial budgets related to Research Study Maintenance.

Design and prepare clinical trial budget amendments pertaining to Research Study Maintenance

Track outside invoices and submit journal entries for payment

Maintain monitor and renew lab contracts

This position can be either hybrid or remote. Must have reliable access to internet. On occasion and at the discretion of the Director of QA the Clinical Trial Assistant Project Manager (Systems use) may be required to be onsite for meetings, sponsor audits or regulatory inspections. Advanced notice will be given.

Additional Job Details (if applicable)

Remote Type

Hybrid

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

1200 The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at View phone number on aiapply.co.

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.