Clinical Trial Assistant Project Manager

Mass General Brigham•Boston, MA

2d•Hybrid

About The Position

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. 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. Assists with coordination of CTNI-managed clinical trials.

Requirements

BA or BS
Minimum of 1-3 years of work experience
Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communication

Nice To Haves

clinical research experience helpful
Familiarity with statistical packages (SPSS, SAS) desirable
Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate

Responsibilities

Schedule SAFER interviews with sites
Obtain interview results from doctors, track results, and communicate results to sites and sponsors
Manage Rater Training using Excel, MGH LMS and RedCap
Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc.
Organize and attend conference calls and distribute minutes accordingly
Attend Investigator and Sponsor Meetings as necessary
Submit study protocols, protocol amendments, and study staff certifications to the IRB
Coordinate and respond to audits by study sponsors
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 PI to 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