Clinical Support Spec 1

Planet Pharma; Irvine (CA); On-site; USD 41,000 - 51,000; Full time

Job summary

Planet Pharma in Irvine, CA, is seeking a self-motivated Clinical Operations Analyst to support clinical study activities, including contract management, budgeting, inventory, shipping, and data entry. The role emphasizes ensuring regulatory compliance and SOP adherence while collaborating with site staff and study personnel.

You will prepare and track contracts, process POs and invoices, monitor site payments, generate reports, and maintain study documents using MS Excel and other MS Office

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 related materials to assure quality and organization of all assigned study projects.
• Prepare 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 payments and align with budgets.
• Communicate with investigator, site staff and internal project teams.
• Order equipment for studies, manage inventory and shipments to sites.
• Follow SOPs to ensure device accountability.
• Support Site and Sponsor communications along with study documentation.
• Attend meetings and document discussions.
• Track and maintain Clinical study related documents.
• Support data analysis using MS Excel and organize reports.

Skills

Microsoft Office

Contract terms understanding

Cross-functional collaboration

Communication skills

Job description

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
• Orderequipment 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 withclinical 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.

Pay Range:

30-37/hr *based on experience