Clinical Research Specialist

Diagnostica Stago•Virtual, GA

1d•Remote

About The Position

The Clinical Research Specialist will design and write investigational clinical trial research protocols, detailing study procedures, hypotheses, and aims. This role involves assessing design constraints, staying current with product capabilities and industry trends, and maintaining scientific relationships with opinion leaders. The specialist will collaborate with international counterparts on study protocols, data collection tools, and other essential documents for clinical trials in the US, supporting new Hematology and Hemostasis products. Responsibilities include drafting the Clinical Trial Management Design, leading field evaluations for potential study sites, communicating and training on protocols, performing validation checks, and analyzing data using statistical knowledge. The role also involves creating final reports, staying current with FDA and CLSI regulations, developing study-related documents, assisting with budget and cadence, supporting site onboarding, managing contractual elements, giving scientific presentations, and collaborating with Marketing on external communications.

Requirements

B.S. in R&D Engineering / Biomedical Engineering or Medical Technology/Clinical Laboratory Science or equivalent from an accredited four-year college or university required.
MT(ASCP) Certification or equivalent required
Minimum five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations and training lab staff on new laboratory instrumentation.
Experience in project management, designing, organizing, and conducting clinical trials.
Demonstrated competency in the statistical review and analysis of clinical data.
This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as determined by customer requirements.

Nice To Haves

Experience in IVD product development is preferred.
Applications, Minitab, Analyze-it or other statistical software and other company software.

Responsibilities

Designs and writes detailed training materials.
Design and writes investigational clinical trial research protocols detailing study procedures, hypotheses, and aims.
Assesses design constraints (cost, complexity/risk and timeframe) at an early stage of the project for presentation to management.
Stays current with product capabilities and industry in order to advise the organization regarding important scientific developments as well as creating and maintaining a scientific and technical relationship with opinion leaders.
Interacts with groups, such as but not limited to CLSI, CLIA and CAP in order to ensure Stago is at the forefront of the market's evolution.
Collaborates on development of study protocols, data collection tools, lab manuals, case reports, and databases with French counterparts to help conduct and support clinical trials in the US regarding support new Hematology and Hemostasis products and parts
Drafts the Clinical Trial Management Design to include study sites led by motivated, innovative and dynamic opinion leaders in the fields of Hematology and Hemostasis.
Leads field evaluations for potential study sites 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 clearance, present study outcomes to an internal multidisciplinary team.
Performs validation checks to ensure completeness and consistency of data
Uses professional knowledge of statistics/biostatistics to collect, analyze, scrub, summarize, and present data, as well as to draw conclusions
Creates final reports on findings and study results.
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.
Responsible for review and statistical analysis of the data including drafting of the statistical report and final study report.
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.