Spec 1, Clinical Support

$50.40 -$56.00 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
Good written and verbal communication skills
Qualifications:
Must be 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

** This role is onsite five days per week in Irvine, California.

A strong clinical and engineering communication skill set is needed to facilitate working with BD and clinical site teams.

Must be a highly motivated self-starter who is able to achieve results with minimal direction. Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills. Must be proactive and provide attention to details.