Associate, Clinical Research II

Overview

The position oversees the clinical trial process for new diagnostic products.  The process includes participating in the development of clinical trial protocols, establishing the capabilities required for the clinical trial sites to complete the protocols, identifying sites having the proper clinical trial capabilities, managing the clinical trial contract process, and managing the clinical trial sites for compliance.   

Responsibilities

• Training of clinical trial sites and internal departments such as Technical Services may be required.   
• The clinical trial sites may be in North America or Europe so periodic field travel can be expected. 
• Coordinating the logistics of sample and data transfer as well as cost accounting of the clinical trial process will be performed.   
• Supports applicable regulations including ISO 20916, ICH GCP, IDE 21CFR812 Local, State, and/or Federal requirements. 
• In collaboration with other staff, identify potential external sites for the evaluation of new IVDs and performance of clinical trials. 
• Perform detailed investigations, including site visits, to evaluate the technical capability of potential external collaborators. 
• Participate in the identification of collaborators that can provide critical clinical specimens for R&D feasibility and verification studies and for manufacturing validation studies. 
• Participate in the development of clinical trial protocols and prepare final document, which will include evaluation of the individual site’s technical and logistical capabilities to perform the protocols.   
• Coordinate and manage the clinical specimen acquisition process in collaboration with site staff.  
• Coordinate any training required at external collaboration sites, which may include providing on-site training. 
• Coordinate and manage the monitoring of the performance of clinical trial sites by reviewing procedures, personnel and data generated at the sites including period visits to all clinical trial sites.  
• Participate on cross-functional teams with R&D, manufacturing, Regulatory Affairs, Marketing, and Technical Services to bring products through the regulatory process and launched to the field. 
• Work with the clinical trial sites to ensure clinical trial data is published in peer-reviewed journals or other appropriate platforms. 
•  Routinely reviews the Investigator Site File (ISF)/study binder for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.  
• Verifies site compliance with electronic data capture requirements as applicable
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.  Supports subject/patient recruitment, retention and awareness strategies.  Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.  Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Monitoring Associate.  Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Research technical questions through review of periodicals, interaction with in-house personnel, the Internet, and any other resource. 
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees.   
• Candidate will also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems.  Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process. 
• The position requires the maintenance of documentation to meet specific quality standards. 
• Perform other duties as assigned. 

Qualifications

Required Work Experience:  

• Minimum of 7 years experience in the field of IVD  
• 5 or more years experience in laboratory medicine 

Preferred Work Experience: