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 Senior Clinical Research Associate to join our Clinical Operations department. You will be based remotely in Spain covering sites across the country.
You will be responsible for the set up of sites, budget proposals, and liaising with relevant authorities to ensure approvals are in place. Reporting into the CRA Manager and working under the supervision of the Clinical Trial Lead (CTL) and the Project Manager (PM) to conduct pre-study visits, Site Initiation, monitoring of clinical trials and close-out of investigator sites on complex studies run by Simbec-Orion. You will work closely with sponsors, project managers and other members of the study team to ensure study deliverables are met within the project timelines. Minimum Requirements: Essential:
- Bachelor's degree in life Sciences or related fields
- Previous experience as a CRA II
- In-depth knowledge of European clinical research regulations, GCP, and ICH
- Strong problem solving skills
- Multiple therapeutic experience and demonstratable ability to understand complex protocols.
- Deliver results to the appropriate quality and timeline metrics
- Ability to establish and maintain effective working relationships with colleague and clients
- 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.
- Subject matter expert in CTMS and/or eTMF systems
- Advanced Degree (Masters, MD, Phd)
- Previous experience working as a Senior Clinical Research Associate