The Clinical Trials Post-Award Specialist is responsible for the financial administration, compliance oversight, and operational management of an assigned portfolio of industry-sponsored clinical trials, federal clinical research awards, investigator-initiated studies, and other sponsored research projects. This position serves as the primary post-award resource for Principal Investigators (PIs), research coordinators, clinical research managers, and departmental leadership to ensure awards are managed in accordance with sponsor requirements, institutional policies, federal regulations, and generally accepted accounting principles.
The incumbent provides comprehensive post-award management from award setup through project closeout, including financial reconciliation, invoicing, clinical trial revenue management, study budget monitoring, payroll expense transfers, effort reporting, subaward administration, and financial reporting. The position works collaboratively with clinical research personnel, research administration, finance, grants and contracts offices, sponsors, and external collaborators to ensure compliant stewardship of sponsored funds and timely collection of clinical trial revenue.
Key Responsibilities:
Manage a portfolio of industry-sponsored clinical trials, cooperative agreements, federal grants, and investigator-initiated research studies.
Establish and maintain project budgets and financial tracking tools.
Monitor study expenditures to ensure costs are allowable, allocable, reasonable, and consistently treated.
Develop and maintain financial projections for active research studies.
Review budgets and expenditures to identify deficits, surpluses, and compliance risks.
Partner with research teams to ensure appropriate utilization of funds and achievement of study milestones.
Monitor patient enrollment activity and associated research revenue.
Monitor sponsor payments and patient visit reimbursements to ensure accurate and timely revenue collection.
Reconcile sponsor payments against executed clinical trial agreements and enrollment activity.
Investigate and resolve payment discrepancies with sponsors and study teams.
Track outstanding receivables and follow up on overdue payments.
Collaborate with research coordinators and finance personnel to ensure all billable research activities are invoiced appropriately.
Maintain financial documentation supporting sponsor payments and revenue recognition.
Review award notices, contracts, amendments, and modification documents to identify financial and administrative requirements.
Establish new project accounts and funding sources in institutional financial systems.
Process budget revisions, carryforward requests, no-cost extensions, and sponsor prior approval requests.
Maintain accurate award records and supporting documentation.
Coordinate project extensions and modifications with internal and external stakeholders.
Perform monthly reconciliation of sponsored project accounts.
Analyze expenditures for compliance with sponsor and institutional requirements.
Review payroll distributions, supply charges, subcontract invoices, participant payments, and other research expenses.
Identify and resolve accounting discrepancies and errors.
Prepare detailed financial reports such as grant projections for investigators and departmental leadership.
Maintain audit-ready supporting documentation.
Monitor personnel effort charged to sponsored projects.
Review salary distributions for compliance with sponsor commitments and institutional policies.
Process funding distribution changes and payroll expense transfers.
Coordinate effort certification activities.
Assist investigators and research staff in maintaining accurate personnel funding allocations.
Establish and administer outgoing subawards related to clinical research projects.
Coordinate subaward agreements, amendments, and funding modifications.
Monitor subrecipient spending and invoice activity.
Review invoices for accuracy, allowability, and compliance with award terms.
Ensure timely completion of required subrecipient monitoring activities.
Prepare sponsor invoices and financial reports consistent with contract and award requirements.
Assist with preparation of annual, interim, and final financial reports.
Support research teams with progress reporting requirements involving financial information.
Maintain documentation supporting all submitted financial reports.
Ensure compliance with Uniform Guidance (2 CFR 200), NIH policies and procedures, FDA regulations applicable to sponsored clinical research, clinical trial agreement requirements, institutional policies and procedures, and sponsor-specific financial requirements.
Prepare documentation supporting audits, monitoring visits, and financial reviews.
Identify compliance concerns and escalate issues appropriately.
Assist with development and implementation of departmental standard operating procedures (SOPs).
Serve as a post-award subject matter expert for investigators and study teams.
Provide guidance regarding sponsor requirements, allowable costs, effort reporting, invoicing, and financial management.
Participate in departmental training initiatives related to sponsored research administration.
Build collaborative relationships with faculty, research staff, finance teams, grants and contracts personnel, and sponsors.
