Research Services Clinical Sciences Professional, Cohen Lab (open rank, Senior-Principal professional)

Job Summary

The University of Colorado Department of Surgery, Division of Gastrointestinal, Trauma & Endocrine Surgery (GITES), based in the Department of Surgery on the Anschutz Medical Campus in Research Complex 2, will serve as a critical role in assisting and coordinating the daily operations of the Division's research operations. This position plays an integral part of one of the longest funding research groups in GITES and continues the meaningful work of maintaining the vital research support infrastructure for faculty and staff.

The secondary focus area of this position is to assist Principal Investigators with basic science grants management. This would include assisting with grant preparation and ensuring a smooth proposal submission process through the Department of Surgery. This position would serve as the Division liaison with OGC, the Pre-award core, and post award staff in the Department of Surgery, ensuring comprehensive and accurate communication with the PIs and that all sponsor requirements are being met. This position would work with lab staff to ensure budgets and spending policies are being adhered to.

Key Responsibilities

Senior Professional

Clinical Regulatory Management: 10%

• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies.
• Adhere to research regulatory standards. Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.

Administrative Task Oversight: 50%

• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives.
• Ensure that the necessary supplies and equipment for studies are in stock and in working order.
• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention.
• Serve as a resource and participate in study initiation and close out duties
• Develop program/project goals and communicate goals and outcomes with a variety of stakeholders.

Grants, Contracts, and Finance: 40%

• Assist with Material Transfer Agreements, Data Use Agreements, and Research Collaboration agreements.
• Assist with preparation of grant applications and manuscripts, including data analyses, literature searches, drafting of text, confirming affiliations, and linking of funding to accepted manuscripts.
• Attend financial meetings and assist with budget preparations

Principal Professional Only

• {Work Lead} Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff
• {Work Lead} Provide input and feedback to leadership on team members' overall performance, performance evaluations, opportunities for development, and process improvement initiatives
• {Work Lead} Identify training and development opportunities for new and existing team members to study drug and thoroughly document and report all findings to physician and care team
• {SME} Act as a Subject Matter Expert and authority in the areas of for all funded research in this subset of the GITES division including answering questions related to compliance, regulatory submissions, required education, and ongoing management of research studies.

Work Location

Onsite - this role is expected to work onsite and is located in Aurora, CO.