Additional Info

1. Ensure all departmental clinical research adheres to human#subject protections and GCP; oversee IRB submissions, amendments, continuing reviews, adverse event reporting, and maintenance of regulatory binders and SOPs; organize audits and monitoring visits. (E)

2. Coordinate protocol start#up and execution with sponsors, investigators, nursing, and affected UNMC/NM units to meet study requirements and timelines. (E)

3. Develop study protocols and tools (design, case report forms/electronic capture, resource needs, and timelines); draft patient#care budgets; plan study activities; and support data analysis and research meetings. This position will also organize research meetings and assist with writing research papers.  (E)

4. Create and manage data capture instruments; collect, interpret, verify, and record study data—including CRFs—to ensure accuracy and completeness. (E)

5. Maintain regulatory documentation per federal, sponsor, and institutional standards; manage multi#site regulatory files, communications, and required reporting to sponsors and/or FDA. (E)

6. Educate staff on protocol requirements and study procedures. (E)

7. Collaborate with the Clinical Trials Office/data management and statistical teams to support collection, reporting, interpretation, and analysis of patient data; prepare listings and statistical summaries for PIs and sponsors. (E)

8. Conduct literature reviews; contribute to manuscripts, abstracts, and presentations by analyzing and reporting results. (D)

9. Prepare estimated clinical trial patient#care budgets and other budgets for contract review with the Department Administrator; ensure appropriate charge capture and payment reconciliation. (D)

10. Identify and pursue grant opportunities; draft/assist with applications and budgets; and oversee required forms and documentation to completion. (E)

11. Support resident research in collaboration with faculty sponsors, including study design, protocol development, IRB submissions, budgeting, and subject enrollment. (E)

12. Partner with Orthopaedics and Physical Therapy faculty/staff to develop and execute interdisciplinary projects. (E)

1. Coordinate patient scheduling, screening, and enrollment; ensure care and data collection adhere to protocol. (E)

2. Review clinical information with the surgeon/PI at decision points to confirm eligibility and required procedures. (E)

3. Obtain and document informed consent; explain trial purpose, treatment plan, risks/benefits, financial responsibilities, and subject rights. (E)

4. Prepare physician orders; coordinate diagnostic tests/procedures and track completion per protocol. (E)

5. Conduct periodic reviews with the PI; prepare reports and specimens for shipment per protocol requirements. (E)

6. Manage randomization processes when required. (E)

7. Oversee the participant journey from referral through short# and long#term follow#up. (E)

1. Other duties as assigned.

This position requires a high level of independent judgment, critical thinking, and decision-making to manage complex clinical research projects spanning Orthopaedics and Physical Therapy. The incumbent must interpret and apply institutional, sponsor, and federal regulations; resolve study-specific issues; and anticipate potential challenges to maintain compliance and data integrity.

The role involves analyzing multifaceted data from clinical, biomechanical, and administrative sources; synthesizing findings into actionable recommendations; and guiding investigators, residents, and students in research planning and execution. The incumbent must balance competing timelines and priorities, troubleshoot operational barriers, and make real-time decisions related to subject eligibility, protocol deviations, and data accuracy.

Decisions are made within established institutional policies, Good Clinical Practice (GCP), and regulatory frameworks, with consultation from principal investigators and department leadership as needed. This position exercises independent discretion in determining the most efficient path forward while ensuring alignment with study objectives and departmental research goals.

Determined within a relatively short period of time

This position is directly responsible for the coordination of grants and contracts. The amounts can vary from $10,000 to over a $1,000,000.

Poor decision making can have an adverse effect on the credibility of the faculty, department and the University both locally, regionally and nationally. Good decision making has the potential to enhance the reputation of our faculty, department and University.

This position will operate under the oversight of Principal Investigators (PIs) in Orthopaedics and Physical Therapy. Research tasks will be assigned by individual study PIs and reviewed during weekly supervisory meetings. While guidance and support will be provided, the role requires a high level of autonomy, with the expectation that the individual can independently carry out study-related responsibilities without continuous direct supervision.

No

This position will assist the Study Principal Investigators, students, and research fellows, directly supporting the day-to-day operations of research projects.

Office,Mechanical Facilities,Clinical

NA

Infant (6 wks - 12 months),Adult (18-65 years),Geriatric (65 and older),All Age Group

NA

NA

NA

This position can be exposed to fumes in the biomechanics lab and will wear the protective equipment above.

NA