"Do you have a health related degree (Medical, Scientific, Nursing, Pharmacy preferred)? Ideally with already a site monitoring experience? You're fluent in English, French and Dutch and you want to become a CRA as next step in your career? Then we might just have your dream job, apply now!"
The Clinical Research Associate performs site management and monitoring activities and acts as the main line of communication with the participating sites.
- For assigned sites/study(s), the Clinical Research Associate must ensure successful protocol level execution of SMM deliverables involving startup, execution, and closeout.
- The Clinical Research Associate has to ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
- As Clinical Research Associate, you will anticipate and identify site issues that could affect timelines and develop alternative solutions.
- You will ensure clinical trial management systems containing all site-specific information are maintained and kept current.
- The Clinical Research Associate will provide Local regulatory and legal requirement expertise.
- The Clinical Research Associate ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- As Clinical Research Associate, you ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Client Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- As Clinical Research Associate, you must stay abreast of new and/or evolving local regulations, guidelines and policies.
- The Clinical Research Associate, has to ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements.
- You have to prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- The Clinical Research Associate is responsible for coaching and mentoring CRAs for various aspects of work and providing input into their development.
- The Clinical Research Associate may be responsible for being the country point of contact for CROs for an assigned study & may participate/lead in global/local task forces and initiatives.
- As Clinical Research Associate, you have to identify training needs, standardizing and facilitating training solutions for SMM monitors globally.
- As Clinical Research Associate, you provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
- You may be key point of contact in country/district for assigned study.
- The Clinical Research Associate has to update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
- You hold a Bachelors/Masters or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Previous Site Monitoring Experience is a plus
- You are fluent in English, French, Dutch.
- You have strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and make smart decision.
- You have excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- You are proactive, positive and team player, with a hands-on and result oriented attitude.
- You have a strong working knowledge of pre-clinical and clinical research, be familiar with requirement and current attitudes of regulatory agencies, and have efficient writing skills.
- You have demonstrated business ethics and integrity
- You have a strong commitment, willing to take ownership of problems & solve problems
- You have excellent time management skills.
- You have the existing right to work in Europe.
- A balanced salary package based on your capabilities and experience.
- Full Time position
Vacancy number: 18632