Research Scientist

• Support administrative aspects of safety management such as: Data entry and verification
• Manage and respond to project related emails
• Accurate and timely delivery of information to other project team members
• Generate and distribute reports to relevant project team members
• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
• Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation.
• Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
• Assist with the printing, collation and distribution of study materials to project team members, sponsors and sites.
• Assist with query management.
• Assist with User Acceptance Testing (UAT) and manage user access requests (including user reconciliation).
• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Participate in project, program, functional area and general CPC meetings as required.
• Adhere to CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations.
• Serve as a study coordinator for select projects as needed.
• Additional activities as required.

Research Assistant II – Safety

Manager

• Responsible for timely and accurate provision of investigational product(s) (IP) for CPC Clinical Research clinical trials
• Managing outsourcing to external vendors [Contract Manufacturing Organizations (CMOs)] to ensure labeling, packaging and shipping of IP in compliance with applicable regulations
• Establish and document supply chain for each project according to required scope
• Manage supply planning/forecasting to ensure alignment with study activity and timelines
• Assist Legal with obtaining procurement and/or supply agreements for any required commercially sourced products
• Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues
• Manage, reconcile, maintain and report an accurate account of IP inventory on-hand, consumption, movements, lot and expiry tracking
• Collaborate with study team and vendors to assure proper distribution of IP to study sites
• Develop excellent working relationships with QA / RA for timely review and approval of batch records for packaging and labeling of IP
• Coordinate with manufacturer counterparts and their vendors to efficiently manage drug supply
• Support organizational innovation in pragmatic trial design and conduct
• Support development of study specific manuals and work with QA to develop supply related training/instructional materials (i.e., Pharmacy Manual, Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.)
• Participate in relevant team meetings providing clinical supply status reports
• Follow up on reported Temperature Excursions and/or Product Complaints from sites/depots
• Ensure expiry extensions are provided to depot/sites as needed to support continued use
• Manage return and destruction of IP under the direction of RA, with proper documentation of all steps
• Ensure appropriate documentation of IP supply activities are filed in the electronic Trial Master File
• Facilitate the design, review, and approval of IP label text and proofs to meet specific country language(s), translations and regulatory requirements
• Facilitate the development, review, and approval of supply packaging configurations and specifications
• Plan and coordinate Vendor activities for scheduling and production of labels and primary/secondary packaging of IP
• Liaise with appropriate parties to ensure adequate IP supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Batch Release Certificate, Compliance, etc.)
• Coordinate expiry date extensions and re-labeling operations, when applicable
• Manage maintenance of appropriate quantity of retain samples

Drug Supply Manager

Project Manager

• Serve as the project manager for new business opportunities, including RFPs, RFIs, proposals, bids, and partnership discussions.
• Develop and manage detailed project plans, timelines, deliverables, and responsibilities for each new business opportunity.
• Coordinate cross-functional contributors to ensure timely and high-quality proposal development.
• Track progress, risks, dependencies, and deadlines; proactively address issues to keep proposals on schedule.
• Present CPC capabilities to potential partners & funders.
• Partner interactions will span the full project life cycle including relationship initiation, proposal preparation and presentation, transition from proposal to contracting, project kickoff and transition to internal teams, project status updates to the partner and change management, and project closure.
• Develop and maintain positive business relationships with current and new customers; establish regular communication with current clients to provide ongoing updates on project spend, anticipated changes, etc.
• Act as the primary coordinator between business development, operations, finance, legal, and subject matter experts during the pre-award phase.
• Facilitate internal meetings related to new business pursuits, including planning sessions, reviews, and bid defenses.
• Ensure alignment on scope, assumptions, resourcing, and pricing throughout the proposal lifecycle.
• Support development and refinement of project budgets, schedules, and scope of work in collaboration with finance and operational leads.
• Track changes to scope or assumptions and ensure updates are communicated and documented appropriately.
• Assist with preparation of supporting documentation for pricing, contracts, and approvals.
• Lead or support the transition of awarded projects from new business into execution, ensuring a smooth handoff to delivery teams.
• Compile and organize project documentation needed for operational kickoff and onboarding.
• Ensure commitments made during proposal development are clearly communicated to execution teams.
• Work with the Contracts team on contract negotiations (including change orders and amendments), as necessary; ensure the scopes of work accurately align with the approved budgets.
• Maintain proposal trackers, dashboards, and status reports for leadership visibility.
• Identify opportunities to improve new business project management processes, tools, and templates.
• Support standardization of proposal management best practices.
• Perform other duties as deemed necessary.

Research Assistant II – Safety

Drug Supply Manager

Project Manager, Business Development