ClinDatrix is looking to hire a full time Clinical Project Assistant.

Typical Responsibilities

Assist with the assembly of the Trial Master File.

Assist with the generation and maintenance of study-specific electronic tracking tools for the following: regulatory documents, monitoring visit intervals and reports, screening and enrollment, protocol deviations, serious adverse events (SAEs), and study supplies.

Ensure proper shipment and tracking of clinical supplies (e.g., case report forms, site regulatory binders, etc.) to the site.

Review, track, and file screening and enrollment information from the clinical sites.

Review, track, and file updates to regulatory documentation.

Interface with Clinical Research Associates (CRAs) to address issues and resolve problems as directed by the Clinical Project Manager.

Ensure that all study-related documents collected from or submitted by the clinical sites are filed in the Trial Master File.

Index and prepare Trial Master File contents for return to the Sponsor at the close of the clinical trial.

Attend SOP training meetings and ensure that training records are updated.

Assist Clinical Project Manager with any day-to-day study operational issues.

Assist other departments or ClinDatrix personnel as needed.

Qualifications and Requirements

High school diploma or the equivalent

Excellent accuracy and attentiveness to detail

Good written and verbal communication skills

Good organizational skills with ability to multitask and prioritize workload

Good computer skills (Word, Excel, Email)

Ability to work within a team matrix

Ability to handle stressful situations and deadlines