Senior Clinical Research Associate
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for an experienced Clinical Affairs (i.e. clinical operations) professional to join our enthusiastic and collaborative team.
The selected individual will:
Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development
Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality
Report to Director, Clinical Affairs, Quality, Point of Care Business Area
Managing clinical studies independently, which may include protocol development including risk rationales and study design, ICF and CRF development, investigational product supply management, budget/contract negotiation and regulatory document management
Conducting and/or assisting clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols
Monitoring conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need
Assisting clinical sites with IRB submission/documentation, as needed
Assisting in the preparation of the clinical portion of Pre-Subs, 510ks and other regulatory submissions
Anticipating and identifying issues; implementing solutions, proposing corrective actions in areas relevant to the role
Cross-functionally assisting other Quality colleagues, Regulatory Affairs and Quality Systems, as workload permits to support efforts in these areas
Required Knowledge/Skills, Education, and Experience
BS/BA in life science discipline
CCRA certification with ACRP or SoCRA
Demonstration of 5-8 years of professional know-how and experience in Clinical Affairs; evidence of successful performance of responsibilities presented above
Experience with in vitro diagnostics and/or medical device industry
Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical study reports, etc.)
Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels
Ability and willingness to travel, depending upon project need (periodically up to 40% domestically; <10%>10%>
Preferred Knowledge/Skills, Education, and Experience
Medical Technologist or similar (MT/MLT) highly preferred
Experience with Pre-Subs and 510k submissions
Job ID: 185609
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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