Summary

Penn Medicine Lancaster General Health is seeking a dedicated and detail-oriented Registered Nurse - Clinical Research Coordinator to join our team and play a key role in the recruitment and coordination of clinical trials. In this essential position, you will be responsible for recruiting patients, managing day-to-day clinical trial activities, and ensuring that all processes are conducted in strict accordance with regulatory standards and ethical guidelines.

If you're a motivated, compassionate RN with a passion for clinical research and a keen eye for compliance, we invite you to apply and contribute to the future of healthcare at Penn Medicine Lancaster General Health.

Job Description

LOCATION: Lancaster, PA

HOURS: Full Time (40 hours per week). Monday - Friday. Potential to work remote up to 1 day per week.

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. 

ESSENTIAL FUNCTIONS: Qualified individuals must have the ability (with or without reasonable accommodation) to perform the following duties:

• 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.

• Effective use of MS Office tools, EPIC and clinical research software/s to provide timely updates internally and/or to sponsors

• 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.

• Participates in research operations meetings/s and provide relevant updates on study progress, troubleshooting and recruitment

• 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 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. 

• 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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