Research Services Senior Principal Professional (Research Services Professional, Clinical Sciences)

Research Services Senior - Principal Professional (Research Services Professional, Clinical Sciences) Open Rank - 34041 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Emergency Medicine

Job Title: Research Services Senior - Principal Professional (Research Services Professional, Clinical Sciences) Open Rank

Position: # '00824472 - Requisition: # 34041

Job Summary:

Professional Field

Supervision Received

Supervisory Authority

Key Responsibilities:

General Duties:

• Assist with and oversee the day-to-day operations of clinical trials and studies

  
  


• 
  

  Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial

  
  


• 
  

  Perform informed consent process or ensures that the 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)

  
  


• 
  

  Collect, code, and analyze data obtained from research in an accurate and timely manner

  
  


• 
  

  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

  
  


• 
  

  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

  
  


• 
  

  Independently master study materials, including but not limited to 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 and all the above:

• 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

  
  


• 
  

  Assist with identifying issues related to operational efficiency and shares 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

  
  

Principal professional and all the above:

• Coordinate and administer patient care in compliance with protocol requirements

  
  


• 
  

  Disburse investigation drug and provide patient education regarding administration

  
  


• 
  

  Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team

  
  

Additional Duties & Responsibilities:

• Assist with budget creation and grant submissions

  
  


• 
  

  DOD regulatory and technical reporting submissions

  
  


• 
  

  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, Excel) to support tracking of project/recruitment activities.

  
  


• 
  

  Oversee student worker(s) or junior PRAs as it relates to a specific project.

  
  


• 
  

  Participate in instrument creation (REDCap) 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 the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.

  
  


• 
  

  Manage study participant incentive program with the assistance of procurement.

  
  

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Hybrid

Why Join Us:

Position: # '00824472 - Requisition: # 34041

Job Summary:

Professional Field

Supervision Received

Supervisory Authority

Key Responsibilities:

General Duties:

• Assist with and oversee the day-to-day operations of clinical trials and studies

  
  


• 
  

  Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial

  
  


• 
  

  Perform informed consent process or ensures that the 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)

  
  


• 
  

  Collect, code, and analyze data obtained from research in an accurate and timely manner

  
  


• 
  

  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

  
  


• 
  

  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

  
  


• 
  

  Independently master study materials, including but not limited to 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 and all the above:

• 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

  
  


• 
  

  Assist with identifying issues related to operational efficiency and shares 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

  
  

Principal professional and all the above:

• Coordinate and administer patient care in compliance with protocol requirements

  
  


• 
  

  Disburse investigation drug and provide patient education regarding administration

  
  


• 
  

  Oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team

  
  

Additional Duties & Responsibilities:

• Assist with budget creation and grant submissions

  
  


• 
  

  DOD regulatory and technical reporting submissions

  
  


• 
  

  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, Excel) to support tracking of project/recruitment activities.

  
  


• 
  

  Oversee student worker(s) or junior PRAs as it relates to a specific project.

  
  


• 
  

  Participate in instrument creation (REDCap) 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 the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.

  
  


• 
  

  Manage study participant incentive program with the assistance of procurement.

  
  

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Hybrid

Why Join Us:

Diversity and Equity:

Qualifications:

Minimum Qualifications:

• 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

  
  


• 
  

  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

  
  


• 
  

  Optional Substitution : Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

  
  


• 
  

  Three (3) years clinical research or relate experience

  
  

Preferred Qualifications:

• Four (4) years of clinical research or related experience

  
  


• 
  

  Bachelor of Science in Nursing (BSN) degree

  
  


• 
  

  An Associate Degree in Nursing (ADN) degree and two (2) additional years of experience will substitute for the BSN degree

  
  


• 
  

  Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

  
  


• 
  

  Current licensure as a registered nurse

  
  

Required: Applicants must meet minimum qualifications at the time of hire.

Knowledge, Skills, and Abilities:

• Advanced 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

  
  

How to Apply:

Screening of Applications Begins:

Anticipated Pay Range:

or hiring range

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Background Check Statement:

Vaccination Statement:

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