Penn Medicine, University of Pennsylvania Health System · 8 hours ago
Clinical Research Coordinator - Oncology (Full Time/Days)
Lancaster, PA
Full-time
Onsite
Entry, Mid Level
2+ years expPenn Medicine is dedicated to providing top-tier patient care, conducting innovative research, and educating future leaders in medicine. They are seeking a Clinical Research Coordinator to manage and oversee clinical trials at the Ann B. Barshinger Cancer Institute, ensuring compliance with regulations and effective coordination of research activities.
BiotechnologyEducationHealth CareMedicalTraining
Responsibilities
Plans and coordinates assigned research studies, serves as principal liaison for the project, interfaces with research subjects and collects research data, oversees administrative support, develops appropriate tools needed to conduct the research, and maintains record keeping systems and procedures
Ensures all research activities occur in compliance with guidelines for human subject protection research. Ensures all key personnel engaged in the research study have met training requirements. Serves as a resource to other research staff members regarding assigned clinical protocols
Monitors the progress of research activities, develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding source
Provides regulatory oversight for the conduct of assigned clinical trials. Prepares and oversees LG Hospital IRB submissions and continuing reviews, maintains regulatory and legal documents per IRB, FDA, DOH and other applicable regulatory agencies when required
Develops and implements recruitment strategies in accordance with sponsor requirements. Oversees and conducts informed consent process under direction of Primary Investigator and maintains appropriate documentation according to GCP, FDA, and IRB guidelines
Maintains adequate inventory of study supplies. Oversees and maintains drug and medical device accountability according to regulatory guidelines for receipt, storage, dispensation, and return of investigational product according to SOPs policy on Investigational Drug/Device Accountability
Collaborates with other Research Coordinators, particularly in areas where clinical and non-clinical research areas interface
Contributes to the mentoring of new research staff. Functions as a resource for physicians, other health care providers, and ancillary support staff regarding care of the research participant as it relates to any given clinical research protocol conducts staff in-services as appropriate
Coordinates and manages the patient assessments according to protocol standards at LG Health locations, in a clinically safe and regulatory compliant manner. Utilizes clinical knowledge and assessment skills necessary to evaluate, report, and record accurate medical information including response to therapy according to approved research protocol
Develops and maintains rapport with patients to promote adherence to treatment and data collection protocols. Coordinates participant tests and procedures and maintains study timelines in data collection and completion of case report forms
Assures collected data for any approved research protocol is correct, sufficient, all inclusive, regulatory compliant and the integrity is intact
Maintains study files in accordance with sponsor requirements and LGH SOP Policies, including consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
Assures the source documentation of all research activities is completed and accessible for CRF completion, reporting purposes, and for site visits by Sponsors and other regulatory agencies. Facilitates, conducts and oversees monitoring visits with Sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data
Maintains effective and ongoing communication with Sponsor, research participants and PI during the course of the study
Other duties as assigned
Qualification
Required
Bachelor's degree in a health science or related field (eg, biology, public health, healthcare administration)
Two (2) years' experience in a research or clinical environment
Working knowledge of medical and research terminology
Comprehension of Federal Regulations for Human Subjects in research
Computer Competency including proficiency in Microsoft Outlook, Word, Excel, electronic data capture and electronic health records (EHR) navigation
Preferred
Experience in oncology related research
Research professional certification (CCRP) or willingness to pursue certification
Comprehension and certification in Good Clinical Practices (ICH/GCP) for human research
Benefits
Comprehensive compensation and benefits program
Prepaid tuition assistance programs
Company
Penn Medicine, University of Pennsylvania Health System
Penn Medicine is a world leader in academic medicine, setting the standard for cutting-edge research, compassionate patient care, and the education of future health care professionals.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$70.9MKey Investors
BIRD FoundationWarren Alpert FoundationNational Cancer Institute
2025-01-22Grant
2023-01-03Grant· $9.7M
2022-08-18Grant· $5.7M
Leadership Team
Kevin Mahoney
Chief Executive Officer of University of Pennsylvania Health System
John Donohue
Vice President, Enterprise Services
Recent News
The Philadelphia Inquirer
2026-01-03
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