Freelance Clinical Research Associate /CRA/

reputed company is a global full-service CRO dedicated to reputed company development and providing an excellent work-life balance, with a reputed company-reputed company, reputed company “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 reputed company assigned
• Assists in the selection of sites, site evaluation reputed company, initiation reputed company, and ensuring follow-up by obtaining the reputed company-study documentation to ensure good start-up of the investigation sites.
• May reputed company 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 reputed company in the field and reviews at reputed company visit accuracy, legibility, completeness, and reputed company of the Case Report reputed company (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 reputed company reputed company 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 reputed company and correct supply to the site.
• Cooperates with the site staff for ensuring reputed company reporting from the site of the safety issues (such as reputed company/SAEs, SUSARs, etc.) and their follow-up, guaranteeing reputed company 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 reputed company control of clinical data.
• Promptly address the reputed company Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical reputed company 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 reputed company 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 reputed company will be invited for phone interview as the first reputed company. Unfortunately, due to the number of applications we receive, we cannot reputed company 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-reputed company delivery and results across reputed company our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-reputed company. reputed 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 t Apply tot his job Apply To this Job