Project/programmamanager RED 3.3 CRA
Quest4 - Utrecht
Project/programmamanager RED 3.3\CRAOpdrachtomschrijvingDe doelstelling van het programma is dat de RDI inzicht krijgt in de impact van de RED 3.3 (D, E, F) en de CRA op de RDI en welke maatregelen moeten worden getroffen. - Volledige vacature bekijken
In-house CRA
Oxfordcorp - 21-04-2024
Naar vacature
An inhouse CRA position within a dynamic medical device company appeals to you ? You are fluent in English, have strong planning, communication and multitasking skills ? You are quickly available (May 2nd the latest) and you are open for an office-based position (1 day of home-working + min. 4 days/week working at client's location)? Then check out the opportunity below.
Job description
The inhouse CRA participates in the planning and conduct of the Client's clinical studies. Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager.Ensures compliance to the study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Client Standard Operating Procedures.
Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes.
Primary focus is on providing support of site management activities.
Responsibilities
- Ensure regulatory and clinical protocol compliance for all assigned clinical projects.
- Review informed consent document to ensure all required elements are included.
- Provide product/protocol specific support and training to internal and external clinical personnel.
- In partnership with assigned field staff and in-house personnel; coordinate the start-up and maintenance of the clinical study site.
- Coordinate and lead activities with study specific committees, vendor services, and core labs.
- Conduct the follow-up and resolution of findings from monitoring visits and audits.
- Independently review site compliance and raise issues to study management.
- Serve as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.
- Communicate and collaborate with all levels of employees, customers, contractors, and vendors.
- Apply general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
- Contribute to global process improvements and provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).
- Identify and routinely use the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.
Requirements
- University degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering
- Internship or first working experience in clinical research.
- Fluent in English
- Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills.
- Able to interpret clinical data, meet deadlines and work effectively with all levels of employees.
- Proficiency in Microsoft Office Suite and relevant clinical applications.
- Ability to work independently when necessary.
- Capable of exchanging straightforward information, ask questions, and check for understanding.
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