Senior Project Assistant, Early Phase (Romania)

The Senior Project Assistant works with Project Managers, Project Coordinators and Clinical Research Associates (CRA) at many stages during clinical studies. Works independently to coordinate and manage study deliverables and administrative tasks, as required by the project team.

More specifically, the Senior Project Assistant, Early Phase must :

• Participates and supports the project team for assigned studies with administrative tasks
• Assists with maintenance of projects within Smartsheet and CTMS if applicable (i.e., trackers, contacts, etc.)
• Verification and tracking of vendor and site invoices
• Reconciles project team training against project specific training matrix
• Monthly reconciliation of the project specific training matrix
• Export and send documents to the eTMF, according to the eTMF plan
• Follow-ups with team members for completion of their project specific training
• Assists with initiating and maintaining study files (eTMF)
• Filing of email correspondences in eTMF
• Support with system accesses : creating, management of requests and revoking
• Supports the project coordinators with tracking, uploading and entering metadata for the site regulatory documents
• Supports the project coordinator to resolve the eTMF queries
• Assist with tracking and review of the site close-out documents
• May be assigned to the management of the study specific training in SOLABS
• Update enrollment tracker (screened, randomized, screen failed) for assigned studies
• Download site visit reports and site letters from CTMS and send for upload to eTMF
• May assists with project tracking activities and status reports preparation
• May support with sending and / or collecting documents to sites
• Assist with the periodic review of study files, training documentation and CTMS for completeness (e.g. eTMF, project and systems training completion) and verify that actions items and protocol deviations have been pushed from the site visit reports to the CTMS library
• Prepare site information packages for CRA (e.g. required site follow-up from central monitoring activities, action items, protocol deviations, eTMF completeness, etc) in preparation for their upcoming monitoring visits
• Assist Clinical Research Associate (CRA), Site Visit Report Reviewer (SVRR), Central Monitors (CM) and other Clinical Operations team members with generating reports from clinical systems such as the EDC, CTMS, Smartsheet and TMF (e.g. reports on action items, protocol deviations, data entry and query status, source data verification status, etc…)
• Ensure CRA site assignments are up to date and accurate in CTMS
• Assist with the tracking of visits, site visit report compliance, and study documents
• May assist in the preparation, distribution, and filing of clinical documents and study supplies
• May support other groups within the Early Phase Department with various administrative tasks
• Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project team

Our company : The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks :

About Indero

A Global Clinical Leader In  Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.

Brand name : Indero