Hartmann Young is partnered with an ISO 9001–certified Contract Research Organisation (CRO) to appoint an experienced CRA II. The company delivers high-quality clinical services across Non-Interventional studies, CTIMPs, ATMPs, rare disease and medical device trials, and is expanding due to internal growth and a strong study pipeline.
Role Overview
The CRA II will act as the primary contact for trial sites, ensuring high standards of compliance, documentation, and monitoring across multi-centre studies. You will support site teams and project teams to maintain trial quality and timelines.
Key Responsibilities
* Conduct site selection, initiation, routine monitoring, and close-out activities
* Ensure compliance with GCP, ICH and regulatory requirements
* Build strong relationships with investigators, site staff, and clients
* Deliver SIV training and oversee CRF accuracy and SDV
* Prepare monitoring reports and escalate protocol deviations when required
* Support regulatory/ethics submissions and eTMF quality
About You
* 2–3+ years’ clinical monitoring experience (CRA I or equivalent)
* Experience across Phases I–IV; life sciences degree
* Strong knowledge of ICH-GCP; excellent communication and organisational skills
Desirable: Familiarity with ISO 14155/medical device studies