Are you an experienced CRA in Medical Devices and are interested in an international Sr CRA role without a lot of traveling, covering broad CRA tasks including the coaching of Junior CRAs? Don't hesitate and apply today!
Job Description
As a Senior CRA, part of the clinical research team, you will support the Clinical Project Manager and the Clinical Director and participate in the execution of clinical studies to assess the safety and effectiveness of specific Medical Devices products. Working with confidential patient and company data, you will interface with internal and external stakeholders, managing and monitoring clinical trials in the area of neurovascular or peripheral vascular therapies.
Responsibilities
- Participate in clinical research site management, qualification, initiation, routine monitoring, and final close out.
- Assist with the development and edits of Informed Consent.
- Assist with the development, approval, and distribution of study-related documents including Case Report Forms (CRF's), study manuals, and other study tools to investigational sites and review committees.
- Manage device accountability, inventory, and distribution.
- Monitor ongoing compliance with study protocols and global regulatory guidelines, including safety reporting.
- Prepare and deliver presentations of protocols and other study requirements at site initiations, including training at investigational sites when needed.
- Manage distribution, collection and tracking of regulatory documentation.
- Conduct site visits (region Germany and France), as necessary. Acting as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively.
- Assist Clinical management with regulatory submissions, and other reports as required.
- Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing of SOP's and Work Instructions.
- Train sites to the device as needed.
- Train junior team members.
- Perform other duties/projects as required and assigned.
- Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
- Ensure other members of the department follow the QMS, regulations, standards and procedures.
Requirements
- Bachelor or Master degree
- Business English and native German and/or French
- Five (5) years' experience in clinical/scientific research, nursing, or medical devices/ pharmaceutical industry required, and min 3 years of clinical monitoring experience required.
- Medical Devices experience required.
- EC Submission experience required.
- Excellent verbal, written, and interpersonal communication skills.
- Strong organizational and problem-solving skills.
- Keen attention to detail.
- High level of competence in Word, Excel, PowerPoint or equivalent programs.
- Ability to work in teams and with multiple projects.
- Ability to provide guidance and mentoring to junior Clinical staff
- Existing right to work in Europe required
Information
- Long term project
- Payroll / Freelance
- 0.8 to 1.0 FTE
- Remote position with ad-hoc travel for on-site SQV
