Clinical Research Asst. Project Manager
Massachusetts General Hospital
- Boston, MA Bowdoin, ME
- Permanent
- Full-time
- 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
- 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