Responsible for the study site management for clinical trials being conducted to support applications for research or marketing permits for devices regulated by the FDA or other notified bodies. Working with limited direction, is responsible for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials for Zimmer, Inc to ensure completeness and accuracy of data as well as compliance with U.S. Food & Drug Administration (FDA) or other Regulatory body regulations. In consultation with the Clinical Project Lead and other in-house personnel, coordinates the initiation of the clinical site, conducts clinical site monitoring visits, identifies and obtains missing data and data corrections, maintains accurate, detailed and complete records of monitoring visits and assists in the reporting of study results. Must have the ability to function independently with a remote manager. Other duties may include working on external research projects as a clinical research manager, performing literature reviews, and working on product surveillance plans.
Principal Duties and Responsibilities
-Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, company SOPs, applicable regulatory requirements and defined quality and performance standards.
-Performs pre-monitoring work and compiles post-monitoring reports and follow-up letters in compliance with Zimmer ZWIs.
-Responsible for reconciling third party vendor services (radiology, laboratory) with data received from assigned sites. Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies
-Serves as a research services manager for select sites in conjunction with the External Research Process. Prepares and routes assigned externally funded research protocols and grant applications in compliance with Zimmer policies.
-May perform monitoring or training visits for non-regulated post-market studies as required.
-Participates in the postmarket surveillance process as the clinical team member, may provide literature searches, registry data or study results for annual reports. Ensures complaints and adverse events are captured in as outlined in Zimmer policies.
-Work closely with data management and site to resolve discrepancies.
-Responsible for assisting with PMA preparation (Regulated Trials) or other regulatory submissions which require clinical data by assisting with data cleanup and report writing as needed.
Expected Areas of Competence
-Proficient in Microsoft Office software, including Word, Excel, and PowerPoint; high level of computer literacy and ability to learn new software if required
-Demonstrated ability to understand and comply with applicable FDA/ICH regulations and Company operating procedures, processes, policies, and tasks.
-Requires excellent written and verbal communication skills (i.e., English grammar and style)
-Must possess outstanding organizational skills and attention to detail.
-In-depth understanding of clinical data system and analytical report development from studies.
-Has thorough understanding of the Code of Federal Regulations, Title 21 sections applicable to Good Clinical Practice and the ability to use sound judgment independently on issues related to studies.
-Must be able to perform in a diverse cross-functional team environment
-Ability to multi-task in fast paced environment is essential.
-Ability to function in a team environment under time and resource pressures
-B.S. Degree in the health, life sciences, or engineering disciplines, plus 3 or more years' experience working in a clinical research environment, or an equivalent combination of education and experience.
-Certification as a Certified Clinical Research Professional (CCRP or CCRA) or other certifications preferred.
Up to 75%
This is a field-based position. Candidates must be located in Chicago, IL; Philadelphia, PA; Detroit, MI; or Atlanta, GA.
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