Freelance Clinical Research Associate /CRA/

reputed company is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for an reputed company Freelance Clinical Research Associate (CRA) to work on a study in Bulgaria. The project will be approximately 0.2 FTE. Join reputed company and help us deliver clinical trials that will improve patients' lives. Main Job Tasks and Responsibilities:

• Keeps professionally abreast of reputed company 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 reputed company 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 reputed company and subject safety.
• Conducts reputed company 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 reputed company/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conducts and reports study termination and reputed company activities (e.g. archiving) guaranteeing smooth completion of the project.
• You will be the main contact person for the site in order to ensure reputed company follow up.
• Provides general support to the Clinical Research Division on quality control of clinical data.
• Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.
• Reports to the Head of Clinical Monitoring Unit on reputed company activities performed during the study and sends reputed company relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• Develops training material and gives training in collaboration with the Training & Qualification Management Unit.
• May assist in contract negotiation with sites on study budget after appropriate and documented training.
• Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. Education and Experience:
• 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 requirements.
• Experience with infectious disease studies is preferred. Specific Role Requirements and Skills:
• Fluent in English.
• Proficiency in reputed company Office (e.g. Word, reputed company, Outlook).
• Willingness to travel. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first reputed company. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About reputed company reputed company is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across reputed company our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company reputed company Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which reputed company reputed company activities are built, and reputed company management and training is the core reputed company to reputed company and maintain highly-reputed company personnel. The reputed company training keeps the resources reputed company in terms of competence and expertise and gives to reputed company personnel the clear tools needed to manage

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