Simbec Orion Group Ltd

Clinical Research Associate III

Remote, Germany
08 Jan 2021
30 Jan 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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 III to join our Clinical Operations department. You will be based remotely in Germany.

You will be responsible for the setup of sites, budget proposals, and liaising with relevant authorities to ensure approvals are in place and will be involved with more complex studies and challenging sites to monitor the progress of clinical trials onsite or remotely, to ensure the trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP. Will work closely with sponsors, project managers and other members of the study team (CTLs) to ensure study deliverables are met within the project timelines.

Minimum Requirements:

  • Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
  • Experienced Clinical Research Associate
  • Proficiency in written and spoken English; fluent in host country language
  • Good knowledge of European clinical research regulations and ICH-GCP
  • Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge
  • Ability to establish/maintain good relationships with sites/colleagues/clients
  • Ability to make decisions independently / Strong problem-solving skills
  • Highly developed mentoring and motivational skills

  • Previous CRO experience
  • Good experience in CTMS, eTMF IXRS and EDC systems
  • Advanced degree (Masters, MD, PhD)
  • Experience as a Senior Clinical Research Associate
  • Strong presentation skills
  • Competent in clinical trial planning and metrics management

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.