Clinical Research Education & Training Specialist (Cancer Center)
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Posted Job Title
Clinical Research Education & Training Specialist (Cancer Center)
Job Profile Title
Clinical Research Coordinator C
Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is
instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 14 Research Teams that support disease/discipline specific cancer programs within the ACC.
Job Description
The Clinical Research Education & Training Specialist for the ACC CRU reports to directly to Education and Training Program Manager (PM) and will work closely with the PM in matters related to the training needs for the clinical research staff of the CRU. In this role the Clinical Research Education and Training Specialist implements and continually updates a comprehensive training and orientation program for new hires including Program Managers, Clinical Research Nurses, Research Nurse Practitioners, Clinical Research Coordinators, Regulatory Coordinators, Biospecimen Coordinators, and Research Assistants working to support all ACC CRU Research Teams. Conducts training needs analyses to determine specific training needs for clinical research staff. Trains new staff to independently manage Phase I - IV complex clinical trials including, consenting, screening and enrolling participants after ensuring eligibility, managing participant treatment per protocol, collecting and reporting research data, reporting Serious Adverse Events per protocol, and ensuring adherence to protocol requirements. Creates tools and assessments to ensure effective training of new hires and reduce time to proficiency. Creates and maintains a system to document staff training to ensure completeness and quality of training. Continually assesses new staff to ensure they demonstrate vigilance in patient safety, protocol compliance and data quality. Conducts weekly meetings with new hires to assess progress and provide updates to Supervisor. Mentors and conducts performance monitoring reviews of new staff at the request of Supervisor. Facilitates ongoing training for Clinical Research Staff in conjunction with the Associate Director of Education and Quality Assurance and Program Managers. Identifies, selects, and/or develops appropriate training programs, including the selection or design of appropriate training tools and resources. Develops unit-wide innovations to improve processes and design new tools to increase unit efficiency while reducing errors. Assists ACC CRU Director of Clinical Operations and Associate Directors with writing and reviewing standard operating procedures to ensure staff adheres to all University of Pennsylvania, FDA and GCP guidelines. Assists ACC CRU Director of Clinical Operations and Associate Directors with unit wide improvement projects as needed. Assists Clinical Research Unit Medical Director & the Associate Director of Education & Quality Assurance with creation and implementation of a Training and Orientation program for Investigators.
POSITION IS CONTINGENT UPON FUNDING
Qualifications-
Bachelor's Degree and 3-5 years of related experience or equivalent combination of education and experience required. Training and experience in clinical research or clinical research compliance healthcare required. At least two years of experience in a hospital, academic medical center setting or pharma, with principle responsibilities related to clinical research and or research education preferred. Oncology experience preferred. Working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. Must have effective verbal, written communication and teaching skills. Must be well organized and have strong interpersonal skills.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$50,684.00 - $91,232.00
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
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