Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives. Main Duties and Responsibilities:
We are looking for a Clinical Research Associate II to join our Clinical Operations department. You will be based remotely in Germany and will cover sites across the country.
You will monitor the progress of clinical trials with investigators onsite or remotely, to ensure clinical trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP.
You will attend study meetings, perform visits (independently) and act as a site manager whilst working closely with Project Management to ensure timely delivery of key study tasks. You will have previous experience in a clinical trials environment, or have readily transferable skills and is responsible for conducting site visits independently. Minimum Requirements: Essential:
- Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
- Experience as Clinical Research Associate; or equivalent relevant experience.
- Good Communication Skills
- Proficiency in written and spoken English, fluent in host country language
- Good knowledge of European clinical research regulations & ICH-GCP
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
- Advanced degree (Masters, MD, PhD)
- CRA II experience in a CRO or Pharmaceutical setting
- Strong presentation skills
- Ability to establish/maintain good working relationships with colleagues and clients
- Proven ability to gain in-depth protocol knowledge