Clinical Research Associates - medical devices

Senior CRA / Clinical Research Associate – Medical Devices

Location: Germany (home-based)

Number of site visits: 6-8 within Germany

Salary: €60-73,000 plus benefits

Our client, an international CRO, providing outsourced services to pharmaceutical and biotechnology as well as medical device organisations is looking for CRA’s with experience within medical devices to join their established team 

Who are we looking for

An experienced Clinical Research Associate who is passionate about working at the core of clinical research in an established, structured, and collaborative environment.  A team worker who loves being able to utilise their extensive therapeutic area experience and playing an important role in bring new treatment to patients.

With the ability to work effectively at all levels you will enjoy working cross-functionally and directly with health care professionals monitoring sites as required and have a minimum of 12 months medical device experience.

What will the role involve

Working with multiple medical device sponsors across multiple therapeutic areas but predominantly cardiovascular you will also be responsible for supporting gastro and neurology trials covering various phases (First in Man, Registry, Post-market follow-up) 

Typical responsibilities will include

1. Performing all types of monitoring visits as required (site qualification, site initiation, interim monitoring, site management and close-out visits) Adhering to GCP, ICH guidelines and local regulations as well as internal policies providing country specific expertise. Work with sites to drive recruitment plan in line with project needs. Ensuring safety and rights of patients is maintained throughout the study Supervising the conduct of clinical studies, ensure compliance with protocols, regulatory requirements, and good clinical practice Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness Reviewing the Investigator Site File (ISF) for accuracy

For this role it is important that the person enjoys and can work independently when required as well as provide training and mentoring support to more junior members (depending on level).

Experience / Qualifications required

• Minimum of 12 months medical device independent monitoring experience Life Science degree or equivalent In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Excellent written and verbal communication skills including good command of English language.

This is a great opportunity to join an internationally recognised CRO with a supportive and clear internal career structure supporting your long-term career within clinical research.

For further information on this role and others please get in touch directly on +44 (0)1293 364114