Description
Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.
Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
LOCATION: Lancaster, PA
HOURS: Full Time (40 hours per week). Monday-Friday (8am-4:30pm). No nights or weekends.
Position Summary: Plans, initiates, coordinates, implements, and oversees clinical trials within the LGHealth Research Institute under the direction of the clinical Principal Investigator PI who is responsible for the overall conduct and management of the clinical trial. Coordinates the daily clinical trial activities and plays the critical lead role in the conduct of clinical studies in accordance with local, state, and federal regulations. Must display dedication, enthusiasm, commitment, confidentiality, and flexibility with cross coverage of sites and with on-call hours when required.
Qualified individuals must have the ability with or without reasonable accommodation to perform the following duties:
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Plans and coordinates assigned research studies, serves as principle 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. Performs nursing responsibilities as needed based on research study requirements.
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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.
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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.
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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.
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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.
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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.
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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.
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Coordinates and manages the patient assessments according to protocol standards at LGHealth 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.
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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.
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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.
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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.
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Maintains effective and ongoing communication with Sponsor, research participants and PI during the course of the study.
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Other duties as assigned.
Minimum Required Qualifications:
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Current license as a Registered Nurse, issued by the PA State Board of Nursing.
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Bachelor's degree in nursing OR Bachelor's degree in related field AND Associate Nursing degree.
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Two years’ experience in a research or clinical environment.
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Working knowledge of medical and research terminology.
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Comprehension of Federal Regulations for Human Subjects in research.
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Computer Competency including proficiency in Microsoft Outlook, Word, Excel, electronic data capture and electronic health records EHR navigation.
Preferred Qualifications:
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Comprehension and certification in Good Clinical Practices ICH GCP for human research.
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Research professional certification CCRP or willingness to pursue certification.
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We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.
Live Your Life's Work
We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.
