Are you a Dutch speaking Senior CRA and interested in a very varied CRA function, where you have tasks from A to Z of a clinical study and this in a growing and exciting Medical Devices environment? Then this will be your dream job!
As a Senior CRA you work on assigned clinical studies in the Netherlands to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. You will be handling a study from A to Z, meaning performing site qualification visits, initiation visits, site activation, contract negotiations, study document writing, monitoring, providing training, possible mentoring,…. The clinical sites are in the Netherlands and the main focus will be on monitoring and submission activities.
- Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
- May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. On average 3 site visits per month.
- Serves as primary point of contact for site questions relating to study enrolment, conduct, and close-out issues: liaise with appropriate study team members as needed.
- Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
- Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
- Performs study-related training.
- Manages the development and maintenance of study documents, processes and systems as assigned.
- Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
- Tracks study site and over all study metrics including but not limited to enrolment, deviations, adverse events, trial master file maintenance.
- Provides all job-related progress reports and visit documentation as required.
- May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
- Prepares and coordinates submissions to regulatory authorities.
- Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process.
- Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s).
- Assists in preparing sites for audits and in resolving audit action items.
- Supports sites during audits remotely and/or onsite as needed.
- Participates in meetings with prospective clients.
- Supports training and mentoring of CRAs during remote and onsite visits.
- Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents.
- Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development.
- Supports Core Laboratory management and may serve as the primary contact.
- Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks.
- Performs and summarizes literature searches.
- Registers trials on Clinicaltrials.gov
- May perform other activities as assigned.
- Higher education degree or equivalent education, training, and experience
- Preferred 5 years clinical trial experience
- Preferred 3 years monitoring experience
- Fluency in English and Dutch
- Able to work independently once trained
- Good verbal and written communication skills
- Strong organizational skills
- Basic computer proficiency
- Understanding of clinical research processes and regulations
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience
Vacancy number: 20639