We have a great opportunity for an experienced CRA looking forward to working in the dynamic environment of medical devices. This position is a mix between on-site international monitoring (France, the Netherlands) and start-up activities (Dutch-speaking sites in Belgium, the Netherlands).
Job Description
Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start up, enrollment, follow up and closure of clinical trial activities. Monitoring activities will be in France and in the Netherlands. Start-up activities will concern Dutch sites in Belgium and sites in the Netherlands.
Responsibilities
- Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
- Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
- Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
- Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
- Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
- Collaboration: participates in study-specific meetings, teleconferences and trainings.Collaborates with cross-functional team members and study sites throughout all study phases.
- Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Requirements
- Knowledge : A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
- Problem Solving: Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.
- Planning and Organization: Plans, organizes, and prioritizes own daily work routine to meet established schedule.
- Discretion/Latitude; Supervision Received; Decision Making: Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpreting established policies, procedures and practices. Work is reviewed for soundness of judgment.
- Business Relationships and Project Management:Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.
- Impact: Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.
- Liaison: Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.
- Mentoring: Provides guidance to less experienced staff.
- Languages: Fluent (oral/written) in Dutch, French and English
- Scientific background and minimum 3 years' experience as a CRA
Benefits
- Full Time position
- A balanced salary package based on your capabilities and experience, including a company car.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17140
