Clinical Research Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Creates and composes comprehensive training materials.

• Develops and writes investigational clinical trial research protocols that outline study procedures, hypotheses, and objectives.

• Evaluates design limitations at the project's initial phase for management presentation.

• Remains updated on product features and industry trends to inform the organization about significant scientific advancements.

• Engages with various groups to ensure Stago remains a leader in the market's progression.

• Collaborates with French counterparts on the creation of study protocols, data collection tools, laboratory manuals, case reports, and databases.

• Oversees field evaluations for prospective study sites.

• Communicates and trains NCRA’s on the protocol and assists the NCRA in executing the study for all external stakeholders.

• Keeps abreast of FDA and CLSI regulations affecting coagulation and hematology.

• Accountable for the creation of study-related documentation.

• Aids in the formation and supervision of the study budget and timeline.

• Responsible for the review and statistical analysis of the data.

⛳️ Requirements

• Bachelor’s degree in R&D Engineering, Biomedical Engineering, Medical Technology, Clinical Laboratory Science, or a related field from an accredited four-year institution is mandatory.

• MT(ASCP) Certification or an equivalent qualification is required.

• At least five years of hospital experience in Hematology and Coagulation, ideally with expertise in validations, correlations, and training laboratory personnel on new laboratory equipment.

• Proven experience in project management, including designing, organizing, and executing clinical trials.

• Demonstrated proficiency in the statistical evaluation and analysis of clinical data.

• Experience in IVD product development is an advantage.

• Familiarity with applications like Minitab, Analyze-it, or other statistical software, along with other company-specific software.

🏝️ Benefits

• Reasonable accommodations are available for individuals with disabilities.

• COVID-19 vaccination is mandatory for employees.

• A competitive salary and benefits package is offered.