Our client is looking for an experienced, clinical research professional, who can work independently and can take on additional coordinating tasks as per project needs.
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), ensure successful protocol level execution of SMM deliverables involving startup, execution, and closeout.
- 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.
- Anticipate and identify site issues that could affect timelines and develop alternative solutions.
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
- Provide Local regulatory and legal requirement expertise.
- Ensure timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- 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.
- Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements.
- Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- Be responsible for coaching and mentoring CRAs and providing input into their development.
- Responsible for mentoring CRAs for various aspects of work.
- 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.
- Responsible for activities as assigned by manager.
- Identify training needs, standardizing and facilitating training solutions for SMM monitors globally.
- 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.
- May be key point of contact in country/district for assigned study.
- Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Strong Site Monitoring Experience.
- Fluent in English, French, Dutch.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and make smart decision.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
- Proactive, positive and team player, with a hands-on and result oriented attitude.
- Strong working knowledge of pre-clinical and clinical research, be familiar with requirement and current attitudes of regulatory agencies, and have efficient writing skills.
- Demonstrated business ethics and integrity.
- Strong commitment, willing to take ownership of problems & solve problems
- Innovate and explore alternative successful ways of working, processes and tools.
- Excellent time management skills.
- A balanced salary package based on your capabilities and experience.
- Full Time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17769