Clinical Science Professional Entry-Senior- Emergency Medicine

Overview

Clinical Science Professional (Open Rank: Entry-Senior) - Emergency Medicine

University of Colorado | CU Anschutz Medical Campus

School of Medicine, Division of Emergency Medicine

Official

Title:

Research Services Clinical Science Professional (Open Rank)

Working Title:
Clinical Science Professional (Open Rank: Entry-Senior)

Position #795275 - Requisition #25450

vaccine preventable diseases link referenced in original posting. (

Note:

link retained for reference only.)

The School of Medicine's Department of Emergency Medicine has an opening for a full-time University Staff (unclassified) Clinical Science Professional (Open Rank: Entry-Senior) position.

Research Services

Clinical Science Professionals entry level intermediate level Senior level

Nature of Work

Clinical Science Professionals

Examples of Duties Performed

Entry Professional:

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Manage and conduct moderately complex research activities that are part of larger project from initiation to close
• Obtain study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in clinical trial
• Perform informed consent process or ensure that informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Identify, screen and consent potential study participants. Interact with clinical staff to confirm eligibility and implement study protocols. Extract relevant data from participant or medical records and enter it into online centralized databases or local data tools
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Evaluate data sets for quality and completeness. Set up and/or run statistical analyses
• Analyze data, including statistical analyses and qualitative assessments of data and data quality. Identify and help solve gaps in data collection
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with FDA, study protocols, department, hospital/clinical SOPs and other regulatory guidelines
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order

Intermediate Professional

• Independently master study materials, including protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study-related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members

Senior Professional

• Assist with developing or developing protocol-specific systems and documents including process flows, training manuals, SOPs and CRFs. Maintains subject-level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and share results with leadership
• 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

Additional Duties & Responsibilities

• Manage and conduct moderately complex research activities that are part of larger project from initiation to close
• Create complex data management and tracking tools (REDCap, ACCESS, Excel) to support tracking of project/recruitment activities
• Oversee student workers or junior PRAs as it relates to a specific project
• Participate in instrument creation and/or analytical structures as appropriate to the project
• Collect study data via complex patient visits, surveys, observations or focus groups. Provide leadership in data collection to other PRAs and students
• Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures
• Help develop study findings for presentation to team and external audiences
• May lead publication development (abstract/manuscript)
• Help with budget management/tracking (under direction of PM/PI)
• Lead manuscript preparation for publication or presentation in scientific forums
• Work with members of…