Clinical Trial Asst Project Manager

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

Expectations for All Employees: Supports the organization's missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership Position Summary: Assists with coordination of CTNI-managed clinical trials

Competencies Required:
Excellent communication skills
Sound interpersonal skills and the ability to supervise others
Ability to work independently and display initiative to introduce innovations to research study
Ability to prepare/monitor budgets
Ability to identify problems and develop solutions
Ability to prioritize tasks and set deadlines

Primary Duties as Assistant Project Manager of a Clinical Trial:
1. Schedule SAFER interviews with sites
2. Obtain interview results from doctors, track results, and communicate results to sites and sponsors
3. Manage Rater Training using Excel, MGH LMS and RedCap
4. Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc.
5. Organize and attend conference calls and distribute minutes accordingly
6. Attend Investigator and Sponsor Meetings as necessary
7. Submit study protocols, protocol amendments, and study staff certifications to the IRB
8. Coordinate and respond to audits by study sponsors

Other Tasks, As Required:
Verifies accuracy of study forms
Updates study forms per protocol
Prepares data for analysis and data entry
Assists with formal audits of data
Assists with study regulatory submissions
Verifies subject inclusion/exclusion criteria
Maintains research data, patient files, regulatory binders and study databases Performs data analysis and QA/QC data checks
May develop systems for QA/QC
Acts as study resource for sites
Prepares for FDA and IRB annual reviews
Recommends protocol changes and may assist with writing protocols and manuscripts
Works with PIto prepare complete study reports
Responsible for quality control
Designs research protocols in conjunction with PI
Assists in the selection of study sites
Tracks and analyzes trends across studies, study sites, and CTNI clinicians Invoices sponsors and processes payments to vendors
Orders supplies, handles computer and telephone issues, and communicates with property management
Participates in regular meetings with operations and clinical teams
Facilitates any rater communication with study sites as requested Creates/distributes study reminders
Acts as general resource for study information

Work Schedule: Monday through Friday, 9:00AM to 5:30PM

Working Relationships: Must be able to communicate well both verbally and in writing with internal and external clients

Qualifications

Requirements: BA or BS Minimum of 1-3 years of work experience, clinical research experience helpful Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communication Familiarity with statistical packages (SPSS, SAS) desirable Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate

Additional Job Details (if applicable)

Remote Type

Hybrid

Work Location

15 Parkman Street

Scheduled Weekly Hours

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

- /

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:

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 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.

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