Proclinical is announcing a vacancy for a Clinical Research Associate (CRA) II position for a global Contract Research Organisation (CRO). This partner company prides itself on delivering a complete spectrum of clinical trial and consulting services through the development lifecycle. They are seeking for a talented and hard-working individual to join them as CRA II in their German-based team.
The CRA II will support the clinical team to accurately update and maintain clinical systems and/or trackers within project timelines. This includes the preparation, handling, distribution, filing, and archiving of clinical documentation and reports, along with preparing and distributing meeting agendas and meeting minutes. Above all, they will contribute to the growth and development of the team, providing all manner of related support.
Job Responsibilities:
- Serving as main CTI contact for assigned investigative sites, whilst representing CTI in a professional manner.
- Completing site selection and pre-study activities to identify and evaluate potential investigators.
- Assisting in site evaluation and reports to Study Manager, as appropriate.
- Managing investigative site activity for multiple protocols/indications and providing ongoing updates of site status to the study manager; ensuring compliance and understanding of study requirements by site staff.
- Assisting with study start-up activities: collecting, reviewing, and tracking regulatory site documents, assisting in regulatory submission processes to Ethics Committees and Competent Authorities, and negotiating contracts and budgets.
- Participating in study-specific training and attending Investigator meetings.
- Completing monitoring visits and routing monitoring activities to ensure the integrity, completeness, and accuracy of clinical data and appropriate follow up of study procedures. This includes source document verification and SAE reporting in accordance with the Project Plan, Study protocol, GCP/ICH Guidelines, and applicable Regulations.
- Anticipating/identifying site issues and study deviations, implementing corrective actions, and escalation to Study Manager as necessary.
- Ensuring proper storage, dispensation, and accountability of all investigational products and trial-related material.
- Attending to global project team teleconferences and provides ongoing updates of site status to Study Manager. Maintaining CTI/Sponsor project tracking systems, as required.
- Completing assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.
Skills and Requirements:
- A bachelor's or masters' degree in a health or related science discipline, or equivalent. Health, Natural Sciences, Pharmacy, or Nursing degrees are particularly desirable.
- Research Nurse RN, study coordinator, or 3 year Nursing Diploma with at least 2 years of clinical nursing experience.
- At least 2 years of prior independent clinical monitoring experience.
- Solid knowledge of applicable regulatory requirements in Germany.
- Proficiency in computer software systems, such as MS Office, eTMF, CTMS, etc.
- Excellent communication, presentation, persuasion, and general interpersonal skills are essential.
- Proficiency in TMF systems, filing, reviews, and reconciliation on a global level.
- A thorough understanding of clinical research.
- Strong interpersonal skills with an ability to communicate and persuade across different levels.
- Diplomacy and rationale in difficult situations.
- An ability to handle many tasks, and setting shifting and competing priorities.
- A creative and analytical approach to work, with a focus on detail and accuracy.
- Excellent spoken and written English skills.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 203 846 0643 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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