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84 Overview, PIQs

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Overview

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Clinical Research Professionals (CRPs) at Penn are integral members of the research team. The goal is to have highly trained, competent an motivated individuals in these roles. Some of their job functions include:

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Data Collection, Analysis, or Monitoring
Case Management Of Protocol Participants
Recruitment And Enrollment Of Human Subjects
Protection of Subjects And Subjects’ Rights
Development of Informed Consent Documents
Preparation of Adverse Event Experience Reports
Construction or Monitoring Of Case Report Forms
Maintenance of Drug Accountability Records
Development of Grants And Budgets
Preparation of Reports
Educating Other Healthcare Professionals, Patients or Families About Clinical Trials
Protocol Development
Program Administration
Auditing Research Program
Regulatory document submissions and maintenance

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Training of CRPs is largely competency based using the CTSA (Clinical and Translational Science Awards) Program followed by ACRP (Association of Clinical Research Professionals).

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CRP Career ladder

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Recently, the Office of Clinical Research in partnership with Human Resources and representatives for PSOM departments, centers and institutes have developed career ladders that provide transparency in career growth across the various clinical research domains for management, operations, nursing, data management, quality/ monitoring.

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Each role will require completion of required or recommended trainings in Workday and/ or Knowledge Link as one criterion to move to the next role in the career ladder.

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Roles

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Clinical Research Operations

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OVERVIEW: Clinical Operations refers to the activities that support the clinical trial process from start-up to close out. Clinical Operations professionals are tasked with the planning, implementation, management, and execution of the clinical trial process. This role includes clinical research assistants, clinical research coordinators and clinical research operations professionals.

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Position Information questionnaire (PIQ): These are template PIQs for each job role below. They also exist in Workday. These are confidential, and not to be share outside UPenn/Penn Medicine. Each department may modify these templates to meet their needs.
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aa Director Clinical Research Operations Non Oncology
c1 Associate Director Clinical Research Operations Non Oncology
a1 Clinical Research Assistant A Non Oncology
99 Clinical Research Assistant A Oncology
a1 Clinical Research Assistant B Non-Oncology
b9 Clinical Research Assistant A Biospecimen CRA Oncology
d7 Clinical Research Assistant B Biospecimen Processing CRA Non Oncology
c9 Clinical Research Program Lead A Asst Mgr Biospecimen Oncology
c7 Clinical Research Program Lead A Program Manager Non Oncology
bf Clinical Research Program Lead A Program Manager Oncology
d7 Clinical Research Program Lead B Program Manager Biospecimen Oncology
c7 Clinical Research Program Lead B Program Manager Non Oncology
c7 Clinical Research Program Lead C Program Manager Non Oncology
bf Clinical Research Program Lead C Program Manager Oncology
bf Clinical Research Program Lead B Program Manager Oncology
9d Clinical Research Coordinator A Template Non Oncology
95 Clinical Research Coordinator A Template Oncology
95 Clinical Research Coordinator B Template Oncology
9d Clinical Research Coordinator B Template Non Oncology
99 Clinical Research Coordinator B-C Template Oncology
9d Clinical Research Coordinator C Template Non Oncology
93 Clinical Research Coordinator C Template Oncology

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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Clinical Research Nursing

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OVERVIEW: The specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subject protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings, and clinical specialties (International Association of Clinical Research Nurses. (2012) "Enhancing Clinical Research Quality and Safety Through Specialized Nursing Practice". Scope and Standards of Practice Committee Report)

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Clinical Research Nurse Advanced Practice Provider
86 Clinical Research Nurse Supervisor
74 Clinical Research Nurse B
74 Clinical Research Nurse C
72 Clinical Research Nurse D

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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Clinical Research Monitoring/ Quality

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OVERVIEW: Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements. The clinical research monitor is the person with direct access to, and oversight, of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.

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Clinical Research Director Quality
bc Clinical Research Associate Director Quality
b0 Clinical Research Quality Specialist A
b0 Clinical Research Quality Specialist B
b0 Clinical Research Quality Specialist C
be CRP Safety and Pharmacovigilance Specialist A
be CRP Safety and Pharmacovigilance Specialist B
bc CRP Safety and Pharmacovigilance Specialist C

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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Clinical Research Regulatory Affairs

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OVERVIEW: Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and government approval for clinical trials. These trials often use FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

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Position Information questionnaire (PIQ): These are template PIQs for each job role below. They also exist in Workday. These are confidential and are not to be shared outside UPenn/Penn Medicine. Each department may modify these templates to meet their needs.

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Regulatory Affairs Specialist A
80 Regulatory Affairs Specialist B
80 Regulatory Affairs Specialist C
92 Regulatory Affairs Specialist Supervisor
c0 Regulatory Affairs Associate Director
a8 Regulatory Affairs Director

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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Clinical Research Data Management

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OVERVIEW: This role manages research data, creation of datasets for investigators, performing data quality assurance checks, creation of new summary variables for analysis, and creation of data tables for reports and papers. This role provides general administrative support for research data, completion of data collection forms, extracting and entering required clinical data from medical records and patient research charts to Case Report Forms (eCRFs/CRFs).

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Clinical Research Director Data Technology
8d Clinical Research Data Associate A
8d Clinical Research Data Associate B
89 Clinical Research Data Manager A
89 Clinical Research Data Manager B
8f Clinical Research Data Manager Lead
95 Clinical Research Database Developer A
95 Clinical Research Database Developer B
99 Clinical Research Database Developer Lead

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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Clinical Research Project Management

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OVERVIEW: This role oversees the operation and execution of all aspects of a clinical research study. Includes recruitment of participants and implementation of objectives for each study

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TRAINING: for more information see Required Training section under Clinical Research Professionals.

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