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CLINICAL RESEARCH ASSOCIATE από την εταιρεία Creative Pharma & HR Services SM S.A
Creative Pharma & HR Services S.M SA is a customer-oriented Contract Research Organization offering services to the Pharmaceutical, Biotechnology and Medical Devices Industry. Our mission is to be the trusted CRO Partner that can accommodate Clinical, Medical, Vigilance, Regulatory, Quality and Talent Acquisition projects of all complexity levels.
The quality of our people is the cornerstone of Creative Pharma Services. Our Team consists of passionate, outcome-oriented, collaborative, innovative, enthusiastic and with outstanding academic background people and that is our greatest asset. Due to the expansion of our team we are seeking for a:
The responsibility of a Clinical Research Associate (CRA) in Interventional Clinical Trials (phase II-III) is to prepare the submission files and perform the clinical monitoring aspect of designated projects in accordance with applicable ICH-GCP guidelines, SOPs and international/national regulations. Responsibilities also include performing qualification, initiation, monitoring and close-out of investigational sites.
- Show solid understanding of therapeutic indications and study hypothesis
- Build relationships with investigators and site staff
- Communicate effectively with the other study team members at local and global level
- Prepare submission files to Hospitals, National EC and HA
- Arrange and perform on-site visits in accordance with the monitoring plan
- Conduct on-site study-specific training (if applicable)
- Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
- Perform site facilities inspection
- Ensure completeness and quality of the on-site files
- Update all relevant tracking system on an ongoing basis
- Write the relevant visit/contact report in accordance with monitoring plan
- Attend Audits / Regulatory Inspection if requested
- Life Sciences related degree
- 1- 2 year experience as a CRA in Interventional Clinical trials (phase II-III)
- Familiar with ICH-GCP guidelines
- Computer literacy
- Fluency in written and oral English
- Team oriented person with excellent communication, planning and problem-solving skills
- Ability to travel
- Clean driving license
What we offer
Creative Pharma & HR Services is offering a competitive remuneration package according the Industry’s standards. Nonetheless, we are also proud at Creative Pharma Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.
By sending your CV to us you accept our “Privacy Statement and Terms for submitting your Curriculum Vitae", which is available at http://www.creativephs.com/en/data-protection-policy