Clinical Research Associate & Programs Specialist (Remote)

Aliso Viejo, California, USA        ·       Full time

Job ID:11179BR
Job Title: Clinical Research Associate & Programs Specialist (Remote)
Location: Aliso Viejo, California, USA
650-Clinical Admin-Post Market
$64,321 – $94,337 (Compensation could be higher based on education, experience and skill sets)

Job Description

Supports project managers and Director, Post-Market Clinical Programs in post-market and physician-initiated research efforts.

Job duties:

• Supports startup and execution of post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements.
• Assists project managers in protocol and study documentation development as well as in the IRB approval process and audit preparation.
• Supports budget and contract negotiations with clinical sites.
• Performs study site qualification.
• Facilitates communication with study site/subsite personnel, monitors, vendors, and CROs/coordinating centers.
• Coordinates and participates in investigator meetings, site initiation visits, and training of site staff, monitors, and vendors.
• Partners with study project managers to track study data, enrollment trends, and other metrics.
• Supports setup of single-center case series and pilot data collection by preparing series synopses, proposals, slide deck templates, and contract requests.
• Reviews case series data for trends in support of larger-scale research and distributes internally for educational purposes.
• Facilitates publication support and other investigator-initiated research by participating in proposal review and preparing related grant/contract requests.
• Performs other duties and responsibilities as assigned.

Qualifications

• Bachelor’s Degree in a related field or equivalent experience (life science or engineering preferred).
• Minimum of two to four (2-4) years clinical research experience preferably in the medical device industry.
• Experience supporting post-market clinical studies and other post-market research initiatives.
• Travel required (up to 25%).

Desired Qualifications

• Familiarity with clinical research concepts, terminology, and regulations/guidelines such as FDA Title 21 and Good Clinical Practice (GCP).
• Ability to understand the clinical therapies, procedures, and devices that form the basis of the organization’s research and to review and understand related reports and literature.
• Ability to perform basic data analysis, identify trends, and prepare related reports.
• Outstanding detail-orientation and organizational/time management skills.
• Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and other internal/external business partners.
• Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat.
• Experience using Electronic Data Capture systems desired.
• Global and/or IDE/PMA study experience a plus.

Posting Country: US – United States

Please click here to apply.