Senior Clinical Research Associate (Romanian Speaker)

1w1 week ago

Theradex Oncology

RO · Contract · €30,000 – €50,000

About this role

Theradex Oncology is a full-service CRO celebrating 40+ years, founded in 1982 with an ongoing NCI contract. We conduct early and late-phase oncology trials across U.S., Europe, and Asia, managing over 250 studies. Our mission ensures cancer therapies advance from mice to man for mankind's benefit.

Hiring a freelance SCRA (Romanian speaker) based in Romania at 0.3 FTE per month for a 12-month contract. Responsibilities include preparing project materials, maintaining site communications, and managing regulatory documents. Perform quarterly QC in eTMF and study tracking via CTMS.

Collaborate with project teams, sponsors, and sites to meet regulatory readiness and protocol objectives. Establish routine communications for timely updates on site issues. Participate in monitoring visits including pre-qualification, initiation, routine, remote, and close-out.

Ensure subject protection, data integrity, and GCP adherence across studies. Proactively resolve site issues and escalate data quality concerns. Support multiple studies while advancing cancer treatment innovations.

Requirements

Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience
At least 5 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
Experience in on-site monitoring oncology early phase studies
Thorough knowledge of ICH Guidelines
Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice
Romanian speaker
Familiarity with CTMS and eTMF systems for study tracking
Knowledge of Good Clinical Practice (GCP) and regulatory requirements for oncology trials

Responsibilities

Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, study manuals/binders
Establish and maintain effective, routine communications with study sites, providing timely study updates and support
Perform ongoing management of essential regulatory documentation at the outset and across the lifespan of a study
Perform quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP
Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits
Proactively identify and resolve potential site and study issues
Identify and escalate data quality issues to ensure clinical data integrity
Provide support to project management via ongoing project reports and updates