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Elite Clinical Network · 2 days ago

Clinical Trial Assistant

United States

Full-time

Remote

Entry Level

2+ years exp

Elite Clinical Network is seeking a dynamic and strategic-minded individual to join their team as a Clinical Trial Assistant. This role provides advanced administrative, analytical, and operational support to the Contract & Budget team during the clinical trial start-up and amendment processes, focusing on budget development and contract lifecycle management.

Consumer SoftwareHealth CareMarket ResearchPharmaceutical

Responsibilities

Manage contract intake, routing, tracking, and storage for CTAs, MSAs, SOWs, amendments, CDAs, and vendor agreements

Maintain version control of contract and budget documents, ensuring accuracy and audit readiness

Update status trackers, databases, and dashboards, including cycle-time metrics and negotiation outcomes

Assist with budget documentation, FMV benchmarking entries, and negotiation history tracking

Support communication between internal and external partners by distributing timely updates and follow-ups

Coordinate and assist with internal meetings, negotiation calls, and cross-functional check-ins

Maintain complete and compliant documentation within organizational systems (e.g., shared drives, Salesforce)

Support internal SOPs, workflows, RACI models, and QC processes

Prepare and assist with summaries, reports, and monthly/quarterly C&B performance metrics for leadership

Review sponsor-provided budgets for accuracy, completeness, and alignment with FMV, internal pricing, and site expectations

Track versions of budgets, negotiation history, counter offers, and amendments

Support drafting negotiation rationale, redlines, and responses based on internal guidance

Monitor sponsor responses and ensure timely follow-up to maintain negotiation momentum

Manage contract intake, routing, execution, and archival processes for CTAs, amendments, MSAs, SOWs, CDAs, and vendor agreements

Maintain version control across all documents and trackers (Salesforce, shared drives, eTMF/CTMS)

Perform quality checks to ensure contract terms align with negotiated budgets and organizational standards

Support FMV analysis through cost benchmarking, historical comparisons, and standardized pricing tools

Prepare financial summaries and comparative charts to assist negotiators and leadership

Track contracted budget values, variances from sponsor initial offers, and financial impact of negotiations

Identify potential inconsistencies or missed cost items and escalate appropriately

Serve as an administrative and communication liaison between C&B, BD, Operations, Finance, Regulatory, and Site Managers

Assist in verifying award conditions, site selections, feasibility status, and intake documentation

Help prepare negotiation updates for leadership, BD, and operational stakeholders

Coordinate internal and external meetings, including negotiation calls, kickoff meetings, and status updates

Maintain and update dashboards and trackers for: Contract cycle times, Budget negotiation timelines, Initial vs. final contracted amounts, Amendment metrics, Negotiation outcomes, Prepare recurring and ad hoc reporting packages for leadership

Assist with process improvement activities, SOP updates, and internal audits

Maintain confidentiality and data integrity across all contract and financial materials

Qualification

Clinical research experienceContract negotiationBudget managementCTMS experienceETMF experienceMicrosoft Office SuitePrioritize tasksOrganizational skillsCommunication skillsInterpersonal skillsAttention to detail