Clinical Trial Assistant Project Manager
Mass General BrighamAbout the role
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 trialsCompetencies 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
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$63,252.80 - $102,596.00/Annual
Grade
7
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