Registered Nurse RN Clinical Research Coordinator CRC (Full Time/Days)
Company: Lancaster General Health
Location: Lancaster
Posted on: February 2, 2025
Job Description:
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.
- 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 LG Health 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. JOB REQUIREMENTS
MINIMUM REQUIRED QUALIFICATIONS:
- Current license as a Registered Nurse, issued by the PA State
Board of Nursing.
- Bachelor's Degree in Nursing OR Bachelor's degree in related
field AND Associate Nursing degree.
- 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.
- Computer Competency including proficiency in Microsoft Outlook,
Word, Excel, electronic data capture and electronic health records
(EHR) navigation. PREFERRED QUALIFICATIONS:
- Comprehension and certification in Good Clinical Practices
(ICH/GCP) for human research.
- Research professional certification (CCRP) or willingness to
pursue certification.
- Bilingual - Spanish
Disclaimer: This job description is not intended and should not be
construed to be an exhaustive list of all responsibilities, skills,
efforts, or working conditions associated with the job. It is
intended to be a reflection of those principal job elements
essential for recruitment and selection, for making fair job
evaluations, and for establishing performance standards. The
percentages of time spent performing job duties are estimates, and
should not be considered absolute. The incumbent shall perform all
other functions and/or be cross-trained as shall be determined at
the sole discretion of management, who has the right to amend,
modify, or terminate this job in part or in whole. Incumbent must
be able to perform all job functions safely.
Benefits At A Glance:
PENN MEDICINE LANCASTER GENERAL HEALTH offers the following
benefits to employees:
- 100% Tuition Assistance at The Pennsylvania College of Health
Sciences
- Paid Time Off and Paid Holidays
- Shift, Weekend and On-Call Differentials
- Health, Dental and Vision Coverage
- Short-Term and Long-Term Disability
- Retirement Savings Account with Company Matching
- Child Care Subsidies
- Onsite Gym and Fitness Classes
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.
Keywords: Lancaster General Health, Lancaster , Registered Nurse RN Clinical Research Coordinator CRC (Full Time/Days), Healthcare , Lancaster, Pennsylvania
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