Clinical Research Associate (FSP model) - Greece

Optimapharm

Αθήνα
Μόνιμη
Πλήρης Απασχόληση

Πριν 28 ημέρες

Who are we?Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations.With 26 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.We are looking for a Clinical Research Associate to join our team in Greece and support an International Biopharmaceutical Company in Athens (FSP model).What do we offer?

Working in a successful company that's growing and developing every day
Working with a highly experienced team of clinical research professionals
Professional growth
Performance bonus
Referral bonus
Training opportunities
Flexible work hours
Work from home days
Company car
Additional Health Insurance

Who are we looking for?Qualifications And Experience

University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social, or humanistic sciences must have nursing education or other relevant healthcare college degree.
Prior exposure to clinical trial monitoring is beneficial but not mandatory.
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements, and a strong interest in clinical research
Fluent in local language and English; both, written and verbal
Computer proficiency is mandatory
Ability to read, analyze, and interpret common scientific and technical journals
Excellent verbal and written communication skills
Very good interpersonal and negotiation skills
Ability to work with minimal supervision, proactive
Affinity to work effectively and efficiently in a matrix environment
Excellent numerical skills and reasoning ability
A current, valid driver's license would be advantageous

Your responsibilities

Perform routine site visits with minimal guidance, including pre-study, initiation, interim monitoring, and closeout visits
Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment, and understanding of study requirements
Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
Identify and escalate potential risks and identify retraining opportunities for site personnel
Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow-up of each individual CAPA until timely resolution
Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
With minimal supervision, negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
Administration of site payments in accordance with relevant project instructions

By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

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