Additional Info

1. Lead and manage full-cycle clinical trials including multi-site studies, from initiation through close-out. (E)
2. Coordinate study logistics, including participant recruitment, data collection, and database management. (E)
3. Ensure compliance with institutional, state, and federal regulatory requirements. (E)
4. Maintain IRB submissions, amendments, and compliance documentation. (E)
5. Serve as the primary point of contact for sponsors, CROs, and regulatory agencies. (E)
6. Organize and attend site visits, study meetings, and monitor visits. (E)

1. Manage a remote patient monitoring program for 80–90 postpartum patients/month with hypertensive disorders. (E)
2. Design, implement, and maintain an active clinical database for real-time monitoring. (E)
3. Coordinate training and protocol implementation across multiple hospital systems. (E)
4. Serve as a consultant for external program start-ups, ensuring consistency and integration. (E)
5. Communicate with stakeholders to resolve escalated issues and maintain program performance. (E)

1. Collect data through surveys, medical chart reviews, interviews, and focus groups. (E)
2. Input and manage study data in approved databases; verify data integrity. (E)
3. Assist in data analysis and present findings in internal and external settings. (E)
4. Conduct literature reviews to support ongoing and future research initiatives. (E)
5. Maintain logs, case report forms, and recruitment/screening records. (E)

1. Assist with grant submissions, protocol development, and study budgets. (E)
2. Manage contracts and financial tracking for NIH- and industry-funded trials. (E)
3. Submit IRB applications, continuing reviews, and amendments. (E)
4. Schedule and prepare for Data Safety Monitoring Board meetings. (E)
5. Provide strategic input on new study opportunities and trial design. (E)
6. Manage budgets for multiple complex clinical trials, including federally funded and industry-sponsored studies. This includes tracking study-related expenses, monitoring budget performance, ensuring proper allocation of funds, and working closely with the finance team to reconcile charges.
7. Responsible for pre-award budget planning and post-award fiscal oversight, particularly for high-profile projects such as NIH-funded RCTs and multi-site trials.
8. Ensures sponsor invoicing and payments are processed accurately and on time, assists with contract and grant management, and provides financial updates to principal investigators.
9. While not the final budget approver, the position plays a critical role in maintaining compliance with budgetary guidelines and ensuring that resources are used efficiently to support successful study execution.

1. Train and mentor lower-level staff, students, and volunteers.
2. Facilitate standardized research practices across departments.
3. Guide investigators and teams through study procedures and compliance expectations.
4. Prepare presentations, slides, and publications for dissemination.
5. Review manuscripts for accuracy and compliance with journal and sponsor guidelines.

Very quickly determined

• Responsible for managing budgets for multiple complex clinical trials, including federally funded and industry-sponsored studies.
• This includes tracking study-related expenses, monitoring budget performance, ensuring proper allocation of funds, and working closely with the finance team to reconcile charges.
• Participates in pre-award budget planning and post-award fiscal oversight, particularly for high-profile projects such asNIH-funded RCTs and multi-site trials. This role ensures sponsor invoicing and payments are processed accurately and on time, assists with contract and grant management, and provides financial updates to principal investigators.
• While not the final budget approver, the position plays a critical role in maintaining compliance with budgetary guidelines and ensuring that resources are used efficiently to support successful study execution.

• This role ensures that clinical trials are conducted in accordance with federal regulations, institutional policies, and study protocols—protecting patient safety and data integrity.
• Sound judgment in patient recruitment, protocol adherence, and resource coordination affects not only the outcomes of individual studies but also the department’s ability to attract future funding and collaborative opportunities.
• At a broader level, this position supports the university’s research mission by advancing high-quality, ethical research, helping maintain accreditation standards, and contributing to a culture of accountability and excellence in clinical research.

Works under minimal supervision. Exercises independent judgment and decision-making within established policies and procedures. Supervisor is available for consultation on unusual or complex issues.

No

This position does not have supervisory responsibilities.

Clinical

Adolescence (12-18 years),Adult (18-65 years),Geriatric (65 and older)

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