Spec 1, Clinical Support

MillenniumSoft Inc; Irvine (CA); On-site; USD 69,000 - 77,000; Full time

Job summary

MillenniumSoft Inc. in Irvine, California is seeking a self-motivated Clinical Operations Analyst to support clinical study activities, including payment processing, contract management, inventory management, device procurement, shipping, and data entry, while ensuring compliance with SOPs.

You will track study progress, generate reports, communicate with site staff and study personnel, and help manage budgets and site payments; onsite five days a week.

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.

Responsibilities

• Support study plans, contracts, and other study 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.

Skills

Microsoft Office Suite

Contract terms

Clinical Research industry

Cross-functional teams

Job description

$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.