Clinical Research Specialist

Clinical Research Specialist

Ideal candidates can be located in the Continental United States.

Essential Duties & Responsibilities:

• Design and writes detailed training materials for National Clinical Research Associates (NCRAs)
• Design and write investigational clinical trial research / external validation/ study protocols detailing study procedures, hypotheses, and aims and Data Collection Forms (DCF) in collaboration with DSA Counterparts
• Assesses design constraints (cost, complexity/risk and timeframe) at an early stage of the project for presentation to management.
• Collaborates on development of data collection tools, lab manuals, case reports, and databases with DSA counterparts to help conduct and support clinical trials in the US regarding new Hematology and Hemostasis products and parts.
• Stays current with product capabilities and industry to advise the organization regarding important scientific developments as well as creating and maintaining a scientific and technical relationship with opinion leaders.
• Initiate site selection, contracting, budgeting and submission to the IRB for all studies
• Leads field evaluations and study sites - responsible for overseeing all SIVs, COVs, SEV in collaboration with the NCRA.
• Communicate and train NCRA's on the protocol and supports the NCRA with the execution of the study to all external stakeholders (biologists, clinicians, lab techs) for evaluations of new and existing products.
• In conjunction with the Manager, following completion, present study outcomes to an internal multidisciplinary team.
• Performs validation checks to ensure completeness and consistency of data.
• Provides the locked database to US MA / HQ
• Uses professional knowledge of statistics/biostatistics to collect, analyze, scrub, summarize, and present data, as well as to draw conclusions
• Depending on identified needs, work in collaboration with statisticians, clinicians, biologists, CROs, HQ to analyze data
• Responsible for the statistical analysis and data review process.
• Responsible for the authoring of comprehensive final study reports—including raw data, summaries, and conclusions—in collaboration with the Scientific Affairs CRA manager, to deliver detailed results to Regulatory Affairs
• Keeps current with FDA as well as CLSI regulations that impact coagulation and hematology and clinical trial conduct overall.
• Responsible for the development of study related documents such as study protocol, SIV presentation, RDO, eCRF, DCF, Final Report (as applicable) and all related materials needed to conduct clinical studies. Also responsible for the validation of eCRF's and DCF's for study specific data capture.
• Assist in the development and monitoring of the study budget and study cadence.
• Support on boarding of investigational sites in collaboration with the NCRA's, for the conduct of clinical trials.
• In collaboration with the NCRA, manage the contractual and documentary elements of clinical trial activities.
• Give Scientific Presentations as required.
• Offer support on new product launches as needed.
• Responsible for corroboratively working with Marketing to formulate external communication of study results in the form of publications, posters, etc.
• Organizes and manages study documents in electronic format on Open Text.

Education and/or Experience

• Bachelor's degree in a health-related or scientific discipline (e.g., Biology, Chemistry, Biotechnology) required;
• Master's degree in a related scientific field preferred.
• MT (ASCP) certification or equivalent credential preferred.
• Minimum of five (5) years of hospital laboratory experience, with a focus on Hematology and Coagulation, preferred.
• Minimum of five (5) years of experience in the design, execution, and oversight of clinical trials, including protocol development, participant recruitment, and ensuring regulatory compliance, required.
• Experience working with in vitro diagnostics (IVDs) and familiarity with IVD product development preferred.
• Proven experience managing validations and correlations, as well as training laboratory personnel on new instrumentation and methodologies.
• Demonstrated expertise in project management, including the design, organization, and execution of clinical studies.
• Strong competency in statistical evaluation and interpretation of clinical data is required.
• In-depth knowledge of clinical research processes and regulatory standards.
• Familiarity with electronic clinical trial systems (CTM Ss or EDCs).
• Valid driver's license required.

Up to 40% US travel required during clinical trial conduct.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as determined by customer requirements.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.