Freelance Clinical Research Associate - Remote

Overview

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds. ClinChoice is searching for a Freelance Clinical Research Associate to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines.

In Short

• Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
• Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate after appropriate and documented training.
• Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance.
• Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.
• Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.
• Manages the investigational products (storage, inventory, dispensing records, packaging, and labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
• Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• You will be the main contact person for the site in order to ensure close follow up.

Requirements

• University Degree in scientific medical or paramedical disciplines.
• Previous proven experience as a CRA, performing on-site monitoring activities.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirement.
• Fluent in English and Hungarian.
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
• Willingness to travel.

Benefits

• Work directly for a single sponsor while having the security of a global CRO.
• Opportunities for professional development.
• Supportive work culture.