Home / RN - Clinical Research Coordinator - Lancaster General Hospital (40 hours/week, day shift)

RN - Clinical Research Coordinator - Lancaster General Hospital (40 hours/week, day shift)


At Lancaster General Health, our culture is what sets us apart and creates a lasting impression of our health system in the community and in the hearts of our patients and their families. A role with us is more than just a job, we ask that you Live Your Legacy at LGH by finding your passion in your everyday role, committing to those you serve, and reaching for your personal best.

We are recognized as 1 of only 9 hospitals in the entire country with awards in Medicare.Gov, LEAPFROG and Healthgrades Americas 50 Best Hospitals. We have attained five year Magnet ® recognition status for the fifth time with the American Nurses’ Credentialing Center (ANCC) and we are the 2018 recipient of the Foster G. McGaw Prize in recognition of the commitment to community service.

PENN MEDICINE LANCASTER GENERAL HEALTH offers a comprehensive benefits package:

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 so that our employees can stay actively engaged and committed to living their legacy every day. Together, we will continue to make medical advances that help people live longer, healthier lives.

Join us and be part of a team that empowers you to do more than your job and encourages you to:

Live Your Passion. Live Your Best. Live Your Commitment. Live Your Legacy.

Company

Lancaster General Hospital

Cost Center

3510 Research Institute Operations

Supervisory Organization

Research Institute Operations

Grade

G15

Benefits of Joining Penn Medicine Lancaster General Health:

PENN MEDICINE LANCASTER GENERAL HEALTH combines a Nationally Ranked Hospital with great schools, safe neighborhoods, affordable housing, local community events and festivals as well as a wealth of cultural and recreational activities. The scenic Susquehanna River Valley provides opportunities for fishing, skiing, kayaking, hiking and mountain biking in addition to easy access to NJ shoreline or Delaware beaches. Urban life is easily accessible, with New York, Baltimore, Philadelphia and Washington D.C. a train ride away. Local universities, Fulton Theatre, the downtown shopping and dining district and local sports teams make Lancaster a great place to Live, Work and Play.

Summary

HOURS: Mostly day shift M-F.  Evenings and weekends if study training and/or study patient requires support. On Call evening and weekend rotation shared with other Research Coordinator RNs.

This position is located in Lancaster, PA

  • Current license as a Registered Nurse, issued by the PA State Board of Nursing.
  • Bachelor's Degree in Nursing obtained within 6 months of hire.
  • Two years’ experience in a research or clinical environment. 

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.
  • 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 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.
  • 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.

SECONDARY FUNCTIONS: The following duties are considered secondary to the primary duties listed above:

  • Performs rotating evening and weekend On Call coverage for active research trials if required.
  • Travels to various LGHealth facilities as required to execute trials.   Travels to investigator and clinical research coordinator meetings. 
  • Attends and participates in research team meetings; educational research and clinically relevant workshops; and sessions provided by LGH to maintain skill sets, knowledge base, and continuing educational credits for both  licensure and research certification renewals.
  • Participates in the on-call responsibilities for this position as required.
  • Other duties as assigned.

QUALIFICATIONS:

  • Current license as a Registered Nurse, issued by the PA State Board of Nursing.
  • Bachelor's Degree in Nursing obtained within 6 months of hire.
  • Two years’ experience in a research or clinical environment. 
  • Working knowledge of medical and research terminology.
  • Comprehension of Federal Regulations for Human Subjects in research.
  • Comprehension and certification in Good Clinical Practices (ICH/GCP) for human research.
  • Computer Competency including proficiency in Microsoft Outlook, Word, Excel, electronic data capture and electronic health records (EHR) navigation.

PREFERRED QUALIFICATIONS:

  • Research professional certification (CCRP) or willingness to pursue certification.

Disclaimer

PENN MEDICINE LANCASTER GENERAL HEALTH is an Equal Opportunity Employer, committed to hiring a diverse workforce. All openings will be filled based on qualifications without regard to race, color, sex, sexual orientation, gender identity, national origin, marital status, veteran status, disability, age, religion or any other classification protected by law.

 

Search Firm Representatives please read carefully: PENN MEDICINE LANCASTER GENERAL HEALTH is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at PENN MEDICINE LANCASTER GENERAL HEALTH via-email, the Internet or directly to hiring managers at Penn Medicine Lancaster General Health in any form without a valid written search agreement in place for that position will be deemed the sole property of PENN MEDICINE LANCASTER GENERAL HEALTH, and no fee will be paid in the event the candidate is hired by PENN MEDICINE LANCASTER GENERAL HEALTH as a result of the referral or through other means.

LGH Full Time Posted on 06/06/2021