Clinical Research Associate (m/f/d) - UK

Location: homebased

Who we are

Optimapharm is a globally operating leading midsized fullservice CRO aiming to deliver new therapies to improve and save patients lives.

Optimapharm s key priorities are the wellbeing of our people consistent quality delivery to our clients and healthy sustainable growth.

With 26 strategically located offices Optimapharm operates in 40 countries providing most optimal access to Patients and Investigators globally. Established nearly 20 years ago we leverage our experience stable project teams and collaborative and flexible approach to secure a high level of repeat business gain the trust of new customers and secure continued growth of the company.

We are looking for an experiencedCRAto join ourteam in the UKand 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 changing every day
• Working with a highly experienced team of the clinical research professionals
• International projects andprofessional growth
• Performance bonus
• Training opportunities

Who are we looking for

Qualifications andExperience

• University degree preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least23yearsof independent clinical trial monitoring experience
• High level of knowledge of ICH GCP Guidelines knowledge of regulatory requirements and a strong interest in clinical research
• Fluent in English both written and spoken
• 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 independently proactive
• Affinity to work effectively and efficiently in a matrix environment
• A current valid drivers license

Yourresponsibilities

• Perform routine site visits independently 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
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactive follow 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
• Independently 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 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.