Clinical Research Specialist
- Jefferson Wells
- Fixed-term, Independent, Full-time
Clinical Research Specialist
Our partners innovate to bring treatments to their patients that significantly improve their lives.?Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.
This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Your scope of work?
- Support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
- Participate in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
- May serve as the primary contact for clinical trial sites (e.g. site management)
- Assist in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed;
- Coordination and execution of ordering, tracking, and managing investigational products and trial materials
- Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
- Assist in overseeing the development and execution of Investigator agreements and trial payments
- Assist in clinical data review to prepare data for statistical analyses and publications
- If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
- Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Assist in tracking assigned project budgets
- Develop a strong understanding of the pipeline, product portfolio and business needs
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures
- Performs other duties assigned as needed
- Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple situations but required guidance for complex situations
- Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
- BS with at least 2 years, MS, and PhD with at least 1 year of relevant experience preferred
- Previous experience in clinical research or equivalent is desired
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…)
- Clinical/medical background a plus
- Medical device experience a plus
- Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations
- Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations
- Presentation and technical writing skills
- Written and oral communication skills
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?
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- Company car
- 30 April
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