Altasciences

Operations

• Support Research Associate Supervisors, Study Supervisors, and Study Directors in the scheduling of all Protocol-required tasks for in-life studies, as well as any other departmental related task
• Create the employee daily task schedule based on each study schedule and the departmental needs, as well as employee availability
• Liaison with other departments to coordinate logistical challenges associated with the timing and collection of study-required tasks
• Involved in the departmental and site resource management evaluation and planning
• Assist with verification and posting of all generated schedules
• Be available to assist management with scheduling rearrangements in times of need (e.g., late doses, call-outs)
• Troubleshoot logistical challenges associated with workload and study execution
• May be involved in scheduling consultants and contractors for specialty procedures per Protocol or SOP requirements, as needed
• Maintain consultant and contractor calendar as needed
• May be involved in the creation or the verification of the individual study schedule
• Assist in special projects as needed

Operations Scheduler

IT Support

• Provide accurate and creative solutions to user problems
• Enhance and develop quality support methods and communication skills through coaching feedback
• Assist in the resolution of user and support issues among company sites to ensure timely distribution of knowledge and positive impact on user satisfaction
• Research, resolve, and respond to questions received via phone calls, emails in a timely manner
• Participate in team projects that enhance the quality or efficiency of help desk service
• Through the Helpdesk system, log calls and document the issue, the communication, and the solution of the incident
• Identify recurrent problems and help users to resolve them
• Troubleshoot problems encountered by staff members, user account, email, and user profiles creation / management
• Prepare computers, following the procedure in place for delivery to employees, loading them with the appropriate software and operating system
• Suggest improvements and upgrades to hardware and software
• Train user in the proper use of hardware and software

IT Technician I

Manager

• Provide expertise, strong leadership, and management.
• Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable Standard Operating Procedures (SOPs), regulations, Good Clinical Practice, and study-specific requirements.
• Review visit reports and manage any issues brought to their attention by CRA staff and/or the study team and/or Sponsor.
• Oversee Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution.
• Track clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training.
• May conduct monitoring visits to offer support to project teams.
• Participate in the preparation, conduct and resolution of audits and inspections.
• Contribute to the development, revision, and implementation of Clinical Monitoring SOPs, processes, and study tools.
• Serve as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
• Identify and implement professional development and performance evaluations.
• Act as a mentor to team members to ensure growth and career development.
• Ensure projects/studies are resourced appropriately by allocating and/or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff.
• Conduct Monitoring Oversight Visits to ensure compliance of clinical monitoring team members with regulations, SOP’s, and study requirements.
• Prepare and review budgets for RFPs, as assigned.
• Participate in Bid Defense Meetings, as assigned.
• Perform ongoing reconciliation of clinical monitoring activities against budget.
• Perform additional duties assigned by Clinical Monitoring leadership.

Operations Scheduler

IT Technician I

Manager, Monitoring Services