🎯 Who are we?
Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives.
Optimapharm’ 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.
We are looking for an experienced CRA II to contribute to our team in an FSP model for a leading client. This position offers involvement in clinical trials across various therapeutic areas, while the FSP structure provides the opportunity to concentrate on key tasks and enhance professional development.
🎁 What do we offer?
- Working in a successful company that’s growing and developing every day
- FSP model focused on key tasks and skill development
- Performance bonus
- Referral bonus
- Training opportunities
- 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; nursing education or other relevant healthcare college degree
- At least 1- 2 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 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
📑 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.
