An international contract research organization (CRO) is seeking to recruit a CRA II to its office in Germany. The CRO delivers a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialisation. The organisation's focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise, along with access to a fully integrated multi-speciality clinical research site that conducts phase I-IV trials. This is an exciting opportunity to work with a company that provides life-changing therapies for critically ill patient populations.
- Performs clinical trial initiation, monitoring, and close-out activities while adhering to all applicable regulatory and SOPs.
- Assists with study start-up activities.
- Completes site selection and pre-study activities to identify and evaluate potential Investigators.
- Assists in site evaluation and reports to Study Manager as appropriate.
- Collects, reviews, and tracks regulatory documents when required.
- Participates in study specific training.
- Attends Investigator meetings.
- Completes pre-study visits (PSVs) with study site staff.
- Provides status updates of pre-study and initiation activities to Study Manager.
- Completes site initiation visits (SIVs) with study staff through Protocol and case report form (CRF) training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening / randomization procedures, reviewing serious adverse event (SAE) reporting requirements, and reviewing drug storage and accountability procedures.
- Assists in developing patient enrolment strategies with Project Team and study Site Coordinator.
- Ensures proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials.
- Completes monitoring visits (MVs) to ensure integrity of clinical data and appropriate follow-up procedures, including source document verification (SDV) and SAE reporting in accordance with Project Plan.
- Manages study sites' activities and provides ongoing updates of site status to Study Manager.
- Completes in-house monitoring activities as appropriate, such as updating in-house site files and completing visit reports.
- Maintains tracking records for assigned sites such as tracking of status and source document review (SDV) per patient.
- Completes study site close-out visits (COVs).
- Assists with project-specific administrative activities as member of Project Team.
- Represents the company in professional manner.
Skills and Requirements:
- Degree in Life Sciences.
- At least one year of experience as a Clinical Research Associate (CRA).
- Proven clinical monitoring skills.
- Demonstrable understanding of medical/therapeutic area knowledge and medical terminology.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Reem Iskandarani at +44 203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.