Job Description

Job Description

POSITION OVERVIEW

The primary goal of this position is to manage Contracts Management Systems (CMS) and provide contracts support within the clinical operations and study partnerships back-office function.

The Contracts Coordinator is responsible for ensuring that the status of contracts and related information is accurately entered, maintained, and made available to relevant internal stakeholders and clinical study teams, from internal contract approval through archiving. This role also ensures appropriate filing and prompt availability of all executed contracts.

The Contracts Coordinator provides contracts support as assigned, coordinates activities, and shares best practices with other Contracts Coordinators to ensure timely completion of high-quality deliverables.

Back-Office Vendor Contract Management and CMS Oversight

• Manage the back-office handling of vendor contracts and administration of the Contracts Management System (CMS), including:
• Distributing and tracking contracts for both external and internal signatures until fully executed.
• Supporting increased adoption of electronic signatures and leveraging improved technologies.
• Processing purchase order requests and approvals in accordance with departmental procedures and distributing executed contracts to internal and external stakeholders.
• Ensuring the CMS is consistently up to date for all contracts and relevant documentation.
• Maintaining a clear CMS filing structure and providing internal guidance on filing rules and best practices as needed.
• Ensuring all contracts are scanned, stored electronically, archived in the legal contracts database, and readily accessible to authorized personnel.
• Providing contractual information upon request to relevant internal stakeholders.

Site Contract Management

• Manage the back-office handling of site contracts (including confidentiality and master agreements), including:
• Circulating and tracking site agreements for signature and distributing executed agreements to appropriate parties.
• Preparing and tracking courier shipments of contracts.
• Ensuring availability of executed site contracts by scanning wet-ink documents and distributing copies as required.
• Ensuring electronic filing of site contracts in accordance with departmental procedures.
• Archiving site contracts in the global legal contracts database and managing hard-copy originals.
• Managing correspondence and responding to status inquiries related to site contracts.
• Performing monthly reconciliation checks against received executed contracts.
• Supporting inspection and audit readiness activities related to site contracts.

Electronic Signature Support

• Support electronic signature activities related to site contracts, including:
• Reviewing and approving electronic signature testing for partner or CRO personnel, enabling them to route site contracts.
• Supporting the development of training materials.
• Assisting with KPI tracking and preparation of presentation materials for oversight meetings with external partners.

HCP Contract Request Management

• Manage healthcare professional (HCP) contract requests, including:
• Ensuring timely handling of requests and coordinating backup support during periods of high volume.
• Verifying HCP availability in internal systems and requesting new HCP creation when required.
• Drafting HCP contracts, circulating them for review, and facilitating comments between HCPs and internal reviewers until finalization.
• Initiating, routing, and following up on contract approval forms until final approval.

Departmental and Administrative Support

• Provide departmental support in close collaboration with assigned personnel, including:
• Preparing documents and correspondence in appropriate formats.
• Assisting with the preparation of presentations and meeting minutes.
• Scheduling and organizing meetings (in-person and virtual).
• Updating resource assignments in internal project management systems.
• Coordinating office space, meeting rooms, and equipment needs.
• Ordering office supplies and processing invoices.
• Managing travel arrangements, including flights, hotels, and expense reports.
• Serving as a departmental ambassador to external visitors.
• Providing additional support to clinical operations and study partnership activities as needed.

Additional Responsibilities

• Manage additional operational systems as assigned.
• Identify business improvement opportunities and participate in or lead initiatives to improve efficiency and effectiveness.
• Interact daily with internal stakeholders to ensure seamless integration of activities.
• Ensure adherence to internal SOPs, federal regulations, and GCP guidelines, particularly with respect to clinical study insurance coverage.
• Maintain departmental internal pages and documentation.
• Infrequent travel, including overnight stays, may be required.

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