16 set - Volpiano
Tommaso Leonardi - for CTNI
Location: Padova (PD), Italy
Reports to: Tommaso Leonardi
Time: Full-time
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, the hire is from an EOB (Employer on Behalf)
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 Junior Project Manager of a Clinical Trial:
- Schedule 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
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
- Monitors and evaluates lab and procedure data
- Prepares for FDA and IRB annual
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