Remote Senior CRA - Audiology Trials

Real Staffing Group; Santa Clarita (CA); Remote; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

Company paid life/ad&d insurance

Paid sick and vacation time

TeleHealth options

Tuition reimbursement

Job summary

Advanced Bionics is seeking a Senior Clinical Research Associate to lead global medical device studies from start-up through close-out. You will manage complex investigative sites, drive quality, and mentor CRAs while ensuring regulatory compliance in a remote, globally distributed role.

This role requires 5+ years in clinical research with independent site monitoring, and experience with CTMS, EDC and eTMF systems, plus strong knowledge of ICH-GCP, ISO 14155 and FDA regulations.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 5 years in clinical research with independent site monitoring.
• Experience with CTMS, EDC and eTMF systems and guidelines.

Responsibilities

• Lead operational execution of global clinical studies from start-up to close-out.
• Conduct site qualification, initiation, monitoring visits and close-out.
• Oversee site activation, training, device accountability and milestones.
• Act as operational lead for investigative sites, monitor enrollment and data quality.
• Resolve complex monitoring findings, deviations and data queries.
• Maintain TMF/eTMF and support audits and inspections.
• Collaborate with cross-functional teams and mentor CRAs.

Skills

Site monitoring

CTMS experience

EDC experience

Regulatory awareness

Study management

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Tools

CTMS systems

EDC systems

eTMF systems

Job description

Advanced Bionics is seeking a Senior Clinical Research Associate to lead global medical device studies from start-up through close-out. You will manage complex investigative sites, drive quality, and mentor CRAs while ensuring regulatory compliance in a remote, globally distributed role.

This role requires 5+ years in clinical research with independent site monitoring, and experience with CTMS, EDC and eTMF systems, plus strong knowledge of ICH-GCP, ISO 14155 and FDA regulations.