The Clinical Research Associate II (CRA II) is responsible for effectively managing investigational sites in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting. The CRA II reports to the Senior Manager of Clinical Operations.

 

Essential Functions

• Conduct site qualification, initiation, monitoring and close-out visits and submit timely reports
• Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
• Provide case and follow-up visit support to ensure proper data collection
• Review source documentation, case report forms and data reports for accuracy, completeness and timely submission
• Manage investigational product accountability
• Ensure proper reporting of adverse events and protocol deviations
• Respond to and work with site investigators to ensure resolution and escalate critical compliance issues to manager promptly
• Collect and transfer required site documents for trial master file
• Provide site updates at study meetings
• Attend relevant scientific meetings as directed

Education, Experience and Skill Requirements

• Bachelor’s Degree in science/health-related degree (Health Science, RN, or advanced degree preferred)
• Minimum 2 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies
• Thorough knowledge of CFRs, IDE, NDA, GCPs and ICH Guidelines
• Demonstrate strong interpersonal and organizational skills
• Have excellent verbal and written communication and critical thinking skills along with a positive attitude
• Able to work in a fast-paced environment and complete tasks independently and efficiently with a high attention to detail and accuracy
• Self-motivated, assertive and able to function independently and as part of a team

Other Requirements

• The position may require travel 50-70% of the time, with periods of more frequent travel (up to 85%)

Relocation

Not Available

Location

Field-based position. Company headquarters in Valencia, CA

Company Description

SetPoint Medical is a clinical stage medical device company developing the first implantable neurostimulation device for the treatment of autoimmune diseases.

Apply Now

 

The Senior Clinical Research Associate (Sr. CRA) independently manages and monitors investigational sites and has a thorough understanding of FDA, GCP, and ICH principles. This position oversees study execution from start-up to close-out at assigned study sites, including training, monitoring, and reporting in compliance with study protocols, IRB requirements, applicable FDA regulations, and company procedures.

The Sr. CRA may act as a CRA team lead and must be self-motivated, independent and able to work efficiently in a team environment. The Sr. CRA mentors other team members and participates in development of study protocol and materials. The Senior CRA will report to the Sr. Manager, Clinical Operations.

 

Essential Functions

• Conduct site qualification, initiation, monitoring and close-out visits and submit timely reports
• Ensure adherence to study protocols, company’s SOPs, and compliance with GCP guidelines and FDA regulations and IRB requirements
• Provide case and follow-up visit support to ensure proper data collection
• Review source documentation, case report forms and data reports for accuracy, completeness and timely submission
• Manage investigational product accountability
• Ensure proper reporting of adverse events and protocol deviations
• Respond to and work with site investigators to ensure resolution and escalate critical compliance issues to manager promptly
• Collect and transfer required site documents for trial master file
• Provide site updates at study meetings
• Mentor and train CRAs in accordance with company procedures and ensure consistency with study practices, training, proctoring across CRA team members and clinical sites
• Participate in the development of study documents (protocols, monitoring plans, case report forms, informed consent forms, study manuals) and EDC user acceptance testing
• Review monitoring reports, trend compliance issues, create solutions and escalate to manager, as required
• Assist with routine quality audits to ensure that clinical sites maintain necessary study documentation and adhere to protocol requirement
• Attend relevant scientific meetings as directed

Education, Experience and Skill Requirements

• Bachelor’s Degree in science/health-related degree (Health Science, RN, or advanced degree preferred)
• Minimum 5 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies
• Thorough knowledge of CFRs, IDE, NDA, GCPs and ICH Guidelines
• Demonstrate strong interpersonal and organizational skills
• Have excellent verbal and written communication and critical thinking skills along with a positive attitude
• Able to work in a fast-paced environment and complete tasks independently and efficiently with a high attention to detail and accuracy
• Self-motivated, assertive and able to function independently and as part of a team

Other Requirements

• The position may require travel 50-70% of the time, with periods of more frequent travel (up to 85%)

Relocation

Not Available

Location

Field-based position. Company headquarters in Valencia, CA

Company Description

SSetPoint Medical is a clinical stage medical device company developing the first implantable neurostimulation device for the treatment of autoimmune diseases.

Apply Now