Conduct qualification, initiation, interim monitoring, and close-out visits in accordance with the Monitoring Plan
Ensure investigational sites remain compliant with the approved protocol, regulatory requirements, and Sponsor SOPs
Perform source data review and verification to ensure accuracy, completeness, and traceability of clinical data
Review and ensure timely reporting of adverse events and device deficiencies
Support preparation of FDA Annual Reports and regulatory submissions as applicable
Maintain and reconcile TMF/eTMF documentation to ensure inspection readiness
Provide site training on investigational plan requirements and study procedures
Collaborate with Regulatory Affairs and Data Management to resolve data and compliance issues
Escalate protocol deviations, compliance concerns, or site performance issues as appropriate
Support internal and external audit readiness activities

Requirements

Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of relevant clinical research experience (post-baccalaureate degree preferred)
Minimum 7+ years of clinical research experience, including experience with Phase I–IV clinical trials and/or medical device studies
Experience supporting clinical monitoring activities in a Sponsor or CRO environment, including managing monitoring from site initiation through close-out
Working knowledge of ICH-GCP guidelines, FDA regulations, and applicable clinical research standards (e.g., 21 CFR Parts 50, 54, 56, 812 and ISO 14155)
Experience supporting IDE submissions, PMA-related studies, FDA Annual Reports, and regulatory inspections or audits
Demonstrated ability to identify and manage site compliance risks, maintain regulatory documentation, and ensure protocol adherence
Strong organizational, documentation, and communication skills with the ability to manage multiple sites and tasks within a regulated, cross-functional clinical research environment
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Benefits

Medical, dental and vision coverage*
Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
TeleHealth options
401k plan with company match*
Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Company paid Short/Long-Term Disability coverage (STD/LTD)
STD LTD Buy-ups available
Accident/Hospital Indemnity coverage
Legal/ID Theft Assistance
PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
Paid parental bonding leave
Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
Robust Internal Career Growth opportunities
Tuition reimbursement
Hearing aid discount for employees and family
Internal social recognition platform

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchclinical monitoringsource data reviewregulatory submissionsTMF documentationadverse event reportingprotocol compliancedata verificationaudit readinessIDE submissions

Soft Skills

organizational skillsdocumentation skillscommunication skillsproblem-solvingcollaborationrisk managementtrainingmulti-taskingattention to detailsite management