An excellent opportunity has arisen to join a leading pharmaceutical company as a senior CRA.
*Serves as main contact for assigned investigative sites. Responsible and professional manner.
*Completes site selection and pre-study activities to identify and evaluate potential investigators. Assists in site evaluation and reports to Study Manager, as appropriate.
*Manages investigative site activity for multiple protocols/indications and provides ongoing updates of site status to study manager, ensuring compliance and understanding of study requirements by site staff.
*Assists with study start-up activities: collects, reviews and tracks regulatory site documents, assist in regulatory submission process to Ethic Committees and Competent Authority; and Contract and Budget negotiation.
*Participates in study-specific training and attends Investigator meetings.
*Completes monitoring visits and routing monitoring activities to ensure the integrity completeness and accuracy of clinical data and appropriate follow-up of study procedures, including source document verification and SAE reporting in accordance with the Project Plan, Study protocol, GCP/ICH Guidelines and applicable Regulations.
*Anticipates/identifies site issues and study deviations. Implements corrective actions and a proper escalation to Study Manager, as necessary
*Ensures proper storage, dispensation and accountability of all investigational product(s) and trial-related material
*Attend to global project team teleconferences and provides ongoing updates of site status to Study Manager. Maintain project tracking systems, as required
*Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.
This awaits you:
-A globally organized US company with 9 European
-Owner-led and value-oriented
-A nice and motivated team
-Diverse tasks with an international focus
-Flexible working hours
-Attractive Bonus System
How do you convince us?
-Bachelor's or Master's Degree in allied health fields, such as Health/Natural sciences, Pharmacy, or Nursing.
-Research Nurse RN or study coordinator or 3-year Nursing Diploma with at least 2 years of clinical nursing experience
-At least 4 years of prior independent clinical monitoring experience
-Good Knowledge in applicable regulatory requirements in Germany
-Proficient in the use of laptop computer and software systems (MS-Office package, eTMF, CTMS, etc)
-Excellent communication, presentation, interpersonal skills are essential
-English fluent (both, spoken and written language)
-Reliability and a good sense of team working
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: firstname.lastname@example.org
Tel: +41 4350 86620 or email: email@example.com
Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years.
-We achieve results faster
-Our candidates really are a cut above
-We add greater value
We think it's because we're a private company driven by clients, not by shareholders.
For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.