Senior Clinical Research Associate (Romanian Contractor)

Celebrating 40+ Years!

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

We are hiring a Freelance SCRA (Romanian Speaker) based in Romania 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).
• Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study
• Performs quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
• Performs 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.
• Ensures 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

Level of Education

•  At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.

Prior 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

Skills and Competencies to be demonstrated

• 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
• Candidates must be fluent in Romanian
• Candidate must be fluent in English.

What we offer

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