[Hiring] Senior Clinical Research Associate @Theradex Oncology

Role Description

We are hiring a Freelance SCRA (Romanian Speaker) based in Romania for a 0.3 FTE per month for a 12 months contract. The primary responsibilities of this position include, but are not limited to, the following:

• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, study manuals/binders, etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Collaborate with other members of the project team to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.
• Establish and maintain effective, routine communications with study sites, providing timely study updates and support to sites.
• Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues.
• Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
• Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies).
• 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.
• Perform study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
• Ensure protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
• Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs.
• 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.
• May be responsible for supporting multiple studies simultaneously.

Qualifications

• At minimum, 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.

Requirements

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Highly effective multitasking and execution skills.
• Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
• Excellent organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems.
• Effective knowledge of the drug development process and the Theradex organizational structure.
• Strong communication skills: verbal and written.
• High level of proficiency in Microsoft Outlook, Word and Excel.
• Fluent in Romanian.
• Fluent in English.

Benefits

• Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.