Overview, PIQs

Overview

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:

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

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

CRP Career ladder

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.

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.

Roles

Clinical Research Operations

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.

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

Clinical Research Nursing

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)

Clinical Research Nurse Advanced Practice Provider
Clinical Research Nurse Supervisor
Clinical Research Nurse B
Clinical Research Nurse C
Clinical Research Nurse D

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

Clinical Research Monitoring/ Quality

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.

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

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

Clinical Research Regulatory Affairs

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.

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.

Regulatory Affairs Specialist A
Regulatory Affairs Specialist B
Regulatory Affairs Specialist C
Regulatory Affairs Specialist Supervisor
Regulatory Affairs Associate Director
Regulatory Affairs Director

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

Clinical Research Data Management

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).

Clinical Research Director Data Technology
Clinical Research Data Associate A
Clinical Research Data Associate B
Clinical Research Data Manager A
Clinical Research Data Manager B
Clinical Research Data Manager Lead
Clinical Research Database Developer A
Clinical Research Database Developer B
Clinical Research Database Developer Lead

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

Clinical Research Project Management

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

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