Senior Clinical Research Associate
- Experience Level
- Experienced (non-manager)
A pharmaceutical consultancy is looking for an experienced CRA (Clinical Research Associate) to join their team in Basel.
- The Clinical Research Associate will complete project activities associated with monitoring functions of Phase I-IV clinical research studies whilst developing mastery and a thorough understanding of the drug development process.
- Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a study.
Skills and Requirements
- BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
- Extensive experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
- On site experience: signed off on all types of visits; PSSV, SIV, IMV, COV.
- Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.