Spec 1, Clinical Support

About the role

We are seeking a self-motivated Clinical Operations Analyst to join our growing team in R&D. The Clinical Operations Analyst is responsible for supporting clinical study activities which includes managing clinical operations, including payment processing, contract management, inventory management, device procurement, shipping, and data entry. The Analyst will support with tracking study progress, and generating reports which includes interacting and communicating with site staff and key study personnel. This position will ensure that all activities will be conducted in accordance with regulations and standard operating procedures.

Responsibilities

• Support study plans, contracts, and other study related materials to assure quality, compliance, and organization of all assigned study projects
• Prepare, document and support Master service contracts and Statement of work for different studies
• Processing PO's and Invoices, Site payment monitoring and tracking
• Conduct site budget payment reconciliations to validate the accuracy of payments made against approved budgets, identify and resolve discrepancies, and ensure alignment with contractual terms and financial records
• Effectively work and communicate with investigator, site staff and internal project teams
• Order BD equipment for studies, managing inventory and shipments to study sites
• Follows SOP to ensure device accountability
• Support Site and Sponsor communications along with all study related documentation
• Attend meetings and document discussions
• Track and maintain all Clinical study related documents
• Support data analysis using MS Excel and organize reports of data

Skills

• Good written and verbal communication skills
• Strong clinical and engineering communication skill set
• Highly motivated self-starter able to achieve results with minimal direction
• High-energy individual with excellent teamwork, partnering, and negotiation skills
• Proactive with attention to detail

Qualifications

• Proficient with Microsoft Office Suite (Word, Excel, Power Point, Outlook, Teams)
• Good understanding of contractual terms
• Familiar with Medical, Pharmaceutical or Clinical Research industry
• Ability to work with cross-functional teams

Pay

$50.40 - $56.00

Schedule

Onsite five days per week in Irvine, California.