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

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

University of Colorado Anschutz Medical Campus

Department: Department of Surgery - Division of G.I., Trauma, and Endocrine Surgery

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

Position #: 00840985 - Requisition #:38816

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.

Qualifications:

Minimum Qualifications:

Senior Professional

• Bachelor's degree (in any field)
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• Two (2) years clinical research or related experience

Principal Professional

• Bachelor's degree in any field
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• Three (3) years clinical research or relate experience

Preferred Qualifications

Senior Professional

• Bachelor's degree in science or health related field
• Three (3) years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Principal Professional

• Bachelor's degree in science or health related field
• Four (4) years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Knowledge, Skills, and Abilities

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Ability to communicate effectively, both in writing and orally
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
• Outstanding customer service skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information
• Principal Professional: Expert level knowledge of grant funding

Anticipated Pay Range:

Senior: $56,995-$72,498

Principal: $65,545-$83,373