Experienced Clinical Research (CRA) - Based anywhere in Germany

*Senior Clinical Research Associate - Home Based in Germany - High Salary - Great Reputation*

A great opportunity has risen for a senior clinical research associate based in Germany!

This innovative, scientifically oriented and growing CRO is looking for a new senior CRA. They are offering above market average benefits, the opportunity for leadership positions and career advancements and a great work – life balance.

The Clinical Research Associate with our Global CRO offers the unique opportunity to be involved at every stage of the drug development process by providing unrivaled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you.

Responsibilities:

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation review and verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that only eligible subjects are enrolled;
• Review of regulatory documents;
• Investigational product/drug and/or Medical device accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding medical condition to confirm accurate data reporting in accordance with the protocol, ICH GCP and Local Regulations;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes, but is not limited to providing summaries of the site’s status, significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Requirements:

• Degree in scientific/healthcare related subject
• Willingness to travel
• Good knowledge of English
• Good planning, organization and problem-solving abilities

To apply:

• If you would like to discuss this vacancy further or to discuss your career options in confidence, please e-mail jdawes@planet-pharma.co.uk
• If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
• We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age. Planet Pharma is an Employment Agency providing Global Staffing

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com