Location: home-based
đŻWho we are?
Optimapharm is aglobally operating, leading, mid-sized, full-service CROaiming to deliver new therapies to improve and save patientsâ lives.Â
Optimapharmâ s key priorities are the well-being 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.Â
We are looking for anexperienced Senior CRA to join our team in the UK and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
đ What do we offer?
- Working in a successful company thatâs growing and changing every day
- Working with a highly experienced team of theclinical research professionals
- International projects and professional growth
- Performance bonus
- Training opportunities
đ Who are we looking for?
đŒ Qualifications and ExperienceÂ
- University degree,preferably in medical or life sciences;nursing education or other relevant healthcare college degree
- At least 2-3 years of 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, pro-active
- Affinity to work effectively and efficiently in a matrix environment
- A current, valid driverâs license
đ Your responsibilities
- Perform routine site visits independently, 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
- 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 pro-active follow 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
- 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 fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.Â
If you would be interested in joining the Optimapharm team, pleasesend your CV in Englishand note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.
