Clinical Research Specialist

We are seeking an experienced Clinical Research Specialist to support clinical studies and product evaluations within the hematology and coagulation field. This remote opportunity is ideal for a detail-oriented professional with strong clinical research, laboratory, and statistical analysis experience who enjoys collaborating across multidisciplinary teams and contributing to new product development and scientific advancement. The role offers the opportunity to work on innovative clinical studies, partner with industry experts, and play a key role in supporting product launches and regulatory initiatives.

RESPONSIBILITIES

Develop and prepare study protocols, training materials, laboratory manuals, case report forms, databases, and additional study‑related documentation. Coordinate and support clinical trials involving hematology and coagulation products and instrumentation. Collaborate with cross‑functional and international teams to support clinical research initiatives and study execution. Conduct data review, validation, statistical analysis, and interpretation of clinical study findings. Prepare study reports, presentations, publications, and scientific communications based on research outcomes. Assist with onboarding and support of investigational study sites and external stakeholders. Participate in study budgeting, project timelines, and ongoing study management activities. Provide scientific guidance and stay informed on industry trends, regulatory standards, and product advancements. Support field evaluations, training efforts, and new product launches as needed. Travel domestically as required to support clinical trial activities and study sites.

QUALIFICATIONS

Bachelor’s degree in Biomedical Engineering, Medical Technology, Clinical Laboratory Science, or a related scientific field required. MT(ASCP) certification or equivalent certification required. Minimum of 5 years of experience in hematology and coagulation within a hospital or laboratory setting. Experience with clinical trial coordination, laboratory validations, correlations, and instrumentation training preferred. Strong understanding of statistical analysis and clinical data review. Familiarity with statistical software such as Minitab, Analyze‑it, or similar platforms preferred. Experience supporting IVD product development is a plus. Excellent communication, presentation, organization, and project management skills. Ability to travel up to 40% domestically.

BENEFITS

Fully remote opportunity within the United States. Opportunity to contribute to innovative clinical research and product development projects. Exposure to industry-leading scientific advancements and collaboration with subject matter experts. Career growth opportunities within a highly specialized healthcare and laboratory environment. Ability to make a direct impact on clinical studies, regulatory initiatives, and product launches. #J-18808-Ljbffr Spectrum Staffing Services