Clinical Research Associate mfd - Greece

Who are we

Optimapharm is a leading midsized fullservice CRO working across Europe and North America to deliver new therapies to improve and save patients lives. Optimapharms key priorities are our people and consistently exceeding our clients 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.

Indepth expertise and longstanding 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 Associateto join ourClinical Operations teamin Greeceand support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

What do we offer

• Working in a successful company thats growing and developing every day
• Working with a highly experienced team of clinical research professionals
• International projects andprofessional 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 andExperience

• 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 drivers license would be advantageous

Yourresponsibilities

• Perform routine site visits with minimal guidance including prestudy 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 proactive followup of each individual CAPA until timely resolution
• Preparation of documents required for EC submissions and notifications translation of studyrelated 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 of site contracts as applicable
• Administration of site payments in accordance with relevant project instructions

By joining our fastgrowing 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.