Advarra

General

• Support IRB meeting preparation and coordination: Review submissions for full board assignment to ensure readiness for review
• Assign submissions to upcoming IRB meetings, as directed
• Send assignments and assignment updates to reviewers in CIRBI
• Send clarifications between Client Services and Board reviewers in collaboration with Senior Meeting Coordinator
• Assist with preparation of Meeting and Postmeeting ICFs, as directed
• Assist with preparing meeting determinations in collaboration with Senior Meeting Coordinator
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada,TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards
• Apply negotiated language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s.
• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Complete informed consent quality control check for self and others
• Maintain and increase individual regulatory knowledge to assist with organizational compliance
• Maintain and increase knowledge of U.S. and/or Canadian Federal Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Complete organizational training as required by management
• Attend a minimum of four IRB meetings per month to enhance knowledge and understanding of IRB processes
• Offers process improvement suggestions to management
• Other duties as assigned

Coordinator II, Meeting Coordination

Client Coordinator

• Collaborates with management and Team Lead to drive process enhancements and contributes to the execution of departmental and company strategies
• Acts as a point of contact for IRB customers and provide exceptional customer service to enhance the client experience
• Demonstrates comprehensive understanding across various IRB processes and submission requirements
• Proactively supports the clients, both internal and external, by assisting in a variety of tasks
• Upholds high standards of accuracy and attention to detail, collaborating with internal teams to ensure client satisfaction
• Ensures timely responses to customer inquiries
• Document and track client experience data in system for continuous improvement
• Escalates client concerns promptly to relevant Team Lead and/or Manager
• Collaborate with internal teams to promptly resolve client issues and concerns, proactively addressing potential issues
• Provide client feedback through appropriate channels
• Participate in process improvement discussions
• Act as the primary contact for Advarra teams and CIRBI support, effectively communicating client needs and feedback
• Conduct CIRBI demonstrations to clients
• Subject matter expert for IRB processes and requirements
• Participate in assigned projects
• Completes tasks, as assigned

Coordinator II, Client Experience

Auditor

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Pharmaceutical Quality GCP Auditor – Consulting

• Conduct Good Pharmacovigilance Practice (GVP) audits (planning, agenda, physical or remote audit, and report writing)
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders
• Work collaboratively with clients to ensure quality standards.

Pharmaceutical Quality GVP Auditor – Freelance/Independent Consultant

Pharmaceutical Quality GVP Auditor – Consulting

• Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing).
• Evaluate investigator sites, CROs, and vendor compliance or qualification.
• Prepare comprehensive audit reports detailing findings and root-causes.
• Provide written audit reports in English.
• If required will provide corrective actions support and present findings to QA leadership and stakeholders.
• Work collaboratively with clients to ensure quality standards.

• Collaborates with management and Team Lead to drive process enhancements and contributes to the execution of departmental and company strategies
• Acts as a point of contact for IRB customers and provide exceptional customer service to enhance the client experience
• Demonstrates comprehensive understanding across various IRB processes and submission requirements
• Proactively supports the clients, both internal and external, by assisting in a variety of tasks
• Ensures timely responses to customer inquiries

Project Manager

• Lead customer-facing product implementations
• Support internal organizational initiatives
• Drive successful and timely project completion
• Work with customers to understand processes, goals, and priorities
• Communicate with project stakeholders
• Monitor project work to ensure timely completion
• Identify and communicate project-related risks or issues
• Facilitate cross-functional discussions
• Lead meetings and training events
• Drive data migration activities

Quality Control

• Conducts Quality Control (QC) activities on complex IRB and staff documentation to ensure accuracy compared to primary sources and adherence to applicable quality control standards, federal regulations, and timelines
• Reviews and critically analyzes documents for accuracy in content for assigned submission types
• Provides clear feedback to communicate errors to Research Services staff regarding missing and/or incomplete elements
• Accomplishes daily workload priorities with flexibility and adaptability
• Executes procedures in compliance with internal quality standards and external regulations
• Models QC best practices through peer-to-peer training and mentorship
• Participates in team and department professional and personal development initiatives

Senior Coordinator, Quality Control

• Conduct Quality Control (QC) activities on complex IRB and staff documentation to ensure accuracy compared to primary sources
• Reviews and critically analyzes documents for accuracy in content for assigned submission types
• Provides clear feedback to communicate errors to Research Services staff regarding missing and/or incomplete elements
• Accomplishes daily workload priorities with flexibility and adaptability
• Executes procedures in compliance with internal quality standards and external regulations
• Participate in team and department professional and personal development initiatives

• Support IRB meeting preparation and coordination: Review submissions for full board assignment to ensure readiness for review
• Assign submissions to upcoming IRB meetings, as directed
• Send assignments and assignment updates to reviewers in CIRBI
• Send clarifications between Client Services and Board reviewers in collaboration with Senior Meeting Coordinator
• Assist with preparation of Meeting and Postmeeting ICFs, as directed
• Assist with preparing meeting determinations in collaboration with Senior Meeting Coordinator
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards
• Apply negotiated language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s.
• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Complete informed consent quality control check for self and others
• Maintain and increase individual regulatory knowledge to assist with organizational compliance
• Maintain and increase knowledge of U.S. and/or Canadian Federal Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Complete organizational training as required by management
• Attend a minimum of four IRB meetings per month to enhance knowledge and understanding of IRB processes
• Offers process improvement suggestions to management
• Other duties as assigned

Director

• Responsible for selling specific Advarra services that address the unique business challenges within the clinical trial business process, specifically Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) reviews.
• Collaborate and work with commercial and operational colleagues to grow IRB and IBC services within both existing clients and new sales prospects
• Develop and expand relationships with key IRB and IBC stakeholders at clients
• Lead IRB and IBC opportunities, collaborating with relevant commercial and operational colleagues on discovery calls, solution development and pricing, proposal development, bid defense meetings, and contracting, as applicable
• Stay current on new market and competitive developments in IRB and IBC, and communicate with commercial colleagues on how to capitalize on this information
• Develop and maintain thorough knowledge of the company and its IRB and IBC services / capabilities, research client needs, and identify how our IRB and IBC services can address those needs
• Prospect for new business through traditional sales activities such as email outreach, cold calling, conference attendance, etc.
• Utilize Salesforce to manage accounts, opportunities, contacts and all corresponding activities and communications
• Partner with internal teams to ensure successful implementation of solutions sold and ensure client satisfaction
• Aid in supporting, establishing, and managing quarterly Field Marketing activities for the solutions portfolio, including, but not limited to webinars, conference attendance and presentation, customer and industry events
• Position requires travel 25 - 50% of the time

Strategic Services Director

• Collaborate and work with commercial and operational colleagues to grow IRB and IBC services within both existing clients and new sales prospects
• Develop and expand relationships with key IRB and IBC stakeholders at clients
• Lead IRB and IBC opportunities, collaborating with relevant commercial and operational colleagues on discovery calls, solution development and pricing, proposal development, bid defense meetings, and contracting, as applicable
• Stay current on new market and competitive developments in IRB and IBC, and communicate with commercial colleagues on how to capitalize on this information
• Develop and maintain thorough knowledge of the company and its IRB and IBC services / capabilities, research client needs, and identify how our IRB and IBC services can address those needs
• Prospect for new business through traditional sales activities such as email outreach, cold calling, conference attendance, etc.
• Utilize Salesforce to manage accounts, opportunities, contacts and all corresponding activities and communications
• Partner with internal teams to ensure successful implementation of solutions sold and ensure client satisfaction
• Aid in supporting, establishing, and managing quarterly Field Marketing activities for the solutions portfolio, including, but not limited to webinars, conference attendance and presentation, customer and industry events

Learning and Development

• Develop and deliver professional training events for customers and internal employees; demonstrate expertise in our software products as well as an understanding of customer workflows and unique configurations
• Create and update training documentation, which includes training manuals, assessments, diagrams, PowerPoints, and other supporting materials
• Serve as designated product owner for at least one Advarra technology product and be responsible for ensuring all training materials are updated to match the product release schedule
• Become a software expert in multiple Advarra software application(s); stay up-to-date on new features and version changes
• Develop an understanding of the clinical trial industry, including typical customer processes and standard operating procedures; provide guidance and share best practices with customers

Senior Training Specialist

Manager

• Draft and negotiate a variety of contracts, including master agreements (containing SaaS subscription terms) data privacy agreements, statements of work, software user agreements, business associate agreements, and consulting services arrangements
• Coordinate with internal and external subject matter experts, including external counsel when needed
• Drive the contracting process and serve as point of contact for internal stakeholders and customers
• Respond to inquiries regarding contract interpretation and compliance
• Support continuous improvement of internal processes
• Establish and build good working relationships with internal clients, based on mutual trust and respect, as well as knowledge of the company’s business, needs, and goals
• Work on additional legal or contracting projects as directed
• Maintain contractual records and documentation
• Participate in training new staff
• Other duties as assigned

Coordinator II, Meeting Coordination

Coordinator II, Client Experience

Pharmaceutical Quality GCP Auditor – Consulting

Pharmaceutical Quality GVP Auditor – Freelance/Independent Consultant

Pharmaceutical Quality GVP Auditor – Consulting

Pharmaceutical Quality GCP Auditor – Consulting

Coordinator II, Client Experience

Project Manager

Senior Coordinator, Quality Control

Senior Coordinator, Quality Control

Coordinator II, Meeting Coordination

Strategic Services Director

Strategic Services Director

Senior Training Specialist

Contracts Manager