16 set
|
Tommaso Leonardi - for CTNI
|
Trentino-Alto Adige
16 set
Tommaso Leonardi - for CTNI
Trentino-Alto Adige
Location: Padova (PD), ItalyLe informazioni riportate di seguito illustrano i requisiti del ruolo, l'esperienza richiesta ai candidati e le qualifiche associate.Reports to: Tommaso LeonardiTime: Full-timeExpectations 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 ownershipPosition Summary:Assists with coordination of CTNI-managed clinical trials, the hire is from an EOB (Employer on Behalf)Competencies Required:Excellent communication skillsSound interpersonal skills and the ability to supervise othersAbility to work independently and display initiative to introduce innovations to research studyAbility to prepare/monitor budgetsAbility to identify problems and develop solutionsAbility to prioritize tasks and set deadlinesPrimary Duties as Junior Project Manager of a Clinical Trial:Schedule interviews with sitesObtain interview results from doctors, track results, and communicate results to sites and sponsorsManage Rater Training using Excel, MGH LMS and RedCapManages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc.Organize and attend conference calls and distribute minutes accordinglyAttend Investigator and Sponsor Meetings as necessarySubmit study protocols, protocol amendments, and study staff certifications to the IRBCoordinate and respond to audits by study sponsorsOther Tasks, As Required:Verifies accuracy of study formsUpdates study forms per protocolPrepares data for analysis and data entryAssists with formal audits of dataAssists with study regulatory submissionsVerifies subject inclusion/exclusion criteriaMaintains research data, patient files,
regulatory binders and study databasesPerforms data analysis and QA/QC data checksMay develop systems for QA/QCActs as study resource for sitesMonitors and evaluates lab and procedure dataPrepares for FDA and IRB annual reviewsRecommends protocol changes and may assist with writing protocols and manuscriptsWorks with PI to prepare complete study reportsResponsible for quality controlDesigns research protocols in conjunction with PIAssists in the selection of study sitesTracks and analyzes trends across studies, study sites, and CTNI cliniciansInvoices sponsors and processes payments to vendorsOrders supplies, handles computer and telephone issues, and communicates with property managementParticipates in regular meetings with operations and clinical teamsFacilitates any rater communication with study sites as requestedCreates/distributes study remindersActs as general resource for study informationRequirements:Bachelor degree required.Appreciated a 1-3 years of work experience/clinical experienceMust be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communicationFamiliarity with statistical packages (SPSS, SAS) desirableMust have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriateWork Schedule (flexible):Monday through Friday, 9:00 to 18:30 or 18 (depending on lunch break choice)Working Relationships:Must be able to communicate in English well both verbally and in writing with internal and external clientsSalary: negotiable RAL, spending on experience and previous qualifications.
xysqume The base salary shall start from ****** Euro per year.Deadline for Application:September 15th ****
📌 Clinical Trial Junior Project Manager (Trentino-Alto Adige)
🏢 Tommaso Leonardi - for CTNI
📍 Trentino-Alto Adige