Premier Research - CRA Trainee
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Employer: | Entry Level Jobs in TOP Companies - Hipo.ro |
Domain: |
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Job type: | full-time |
Job level: | Student/Graduate |
Location: |
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Updated at: | 22.11.2016 |
Remote work: | On-site |
Joburi studenti, programe de internship, stagii de practica si joburi entry level de la cei mai mari angajatori din Romania.
Requirements
You'll need this to be considered:
Undergraduate degree or its international equivalent in clinical, science
Previous clinical research experience and/or completion of CRA training program is mandatory
Fluent in English and Romanian- verbal and written
Knowledge of ICH / GCP regulations
Knowledge of web based communication tools for conferences and any other IT systems required for the job
Excellent team player, collaborative and able to enable an effective team
Ability to multitask and work effectively in a fast-paced environment with changing priorities
Excellent organizational and time-management skills, able to meet deadlines
Customer service focused in approach to work, both internally and externally
Valid driver’s license, passport as required
Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic CRA Trainee to join our team! This is an exciting opportunity to join the team in our office in Bucharest, Romania.
You will be accountable for:
Delivering quality, timely monitoring reports for sponsor approval
Scheduling site visits for monitoring
Maintaining submission of expenses
Ensuring the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites
Monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
Planning day to day activities for monitoring of a clinical study and sets priorities per site
Preparing for and conducting on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF)
Assisting project team with assessing project feasibility and recruitment
Maintaining project tracking system of subjects and site information
Ensuring adherence to study timeline and budget
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