Clinical Research Associate (M / F / d) - Italy

Who we are

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

• 27 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

• CRA III / Senior
• to join our
• Clinical Operations team in Italy
• and 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 that’s growing and changing every day
• Working with a highly experienced team of the clinical research professionals
• International projects and professional growth
• Performance bonus
• Training opportunities
• Flexible work hours
• Home-based position
• Summer work schedule

Who are we looking for?

• Qualifications and Experience
• University degree, preferably in medical or life sciences
• Individuals with a university degree in biotechnical, technical, bio-medicinal, social, or humanistic sciences must have a nursing education or other relevant healthcare college degree.
• At least 3 years of independent clinical trial monitoring experience
• Experience in oncology and start-up activities is an advantage
• 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, pro-active
• 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
• Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
• Prepare 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