Clinical Research Nurse Coordinator
Company: Coastal Pediatric Associates
Posted on: January 9, 2021
Position Purpose: This position is responsible for coordinating
clinical trials for Coastal Pediatric Research within Coastal
Pediatric Associates. The Clinical Research Nurse Coordinator
(CRNC) will be responsible for maintaining IRB protocols,
identifying and enrolling appropriate participants, adhering to
study guidelines, coordinating study visits, performing study
assessments, and ensuring participants meet clinical inclusion
guidelines. Additionally, the CRNC will be responsible for
maintaining study databases, completing study documents, recruiting
study participants, laboratory collection and processing of
samples, administering investigational vaccines or drugs, as well
as acting as the unblinded personnel on designated studies. The
CRNC will work with the Principal Investigator (PI) to coordinate
pre-award activities which may include the development and
submission of regulatory documents as well as evaluating and
securing study related materials and services required to conduct
the research. The CRNC will serve as the liaison for the project
which may require the candidate to report information pertaining to
patient enrollment rates and provide justifications for budget
revisions.Performs a variety of duties in accordance with federal,
state and local regulations along with established priorities and
procedures of the Practice.Essential Duties and Responsibilities
(Include but are not limited to):
- Serves as clinical research nurse coordinator (in blinded or
unblinded role) in Coastal Pediatric Research. Obtains informed
consent, screens and enrolls study participants, collects medical
history information, conducts study visits as per protocol,
prepares and administers vaccines as per protocol, coordinates
participant visits, provides education to participants, monitors
adverse events and prepares serious adverse event reports, collects
and processes lab samples, enters data and completes case report
forms, and maintains all study documents. Initiates the creation
and maintenance of all trial files, including source documents.
Responsible for ensuring study documents are complete, organized
and readily available for audits; for ensuring study participants
complete all protocol requirements within designated timeframes;
for ensuring study data is accurate and timely. Coordinates study
activities on a daily basis with all necessary study personnel.
Prioritizes patient safety. Practices full disclosure. Educates
personnel on protocol changes. Provides additional education,
training, and follow-up to personnel and participant/caregiver
where necessary and appropriate. Audits study investigational
medicinal product per protocol.
- Disburses investigational vaccine or drug to participants and
provides teaching regarding administration, as necessary. Performs
clinical tasks including but not limited to: phlebotomy, urine
collection, specimen collection and processing, etc. Maintains
inventory control of all samples and lab kits. Ensures proper
preparation and shipment of samples. Maintains certification(s) in
proper testing and collection techniques. Ensures lack of
contamination through sterile techniques.
- Responsible for recruitment of research study participants on
an on-going basis. Identifies target populations and develops tools
to raise awareness to recruit study eligible patients. Provides
participants with information and education with regard to
appropriate studies. Uses internal patient databases as
professionally appropriate. Works directly with the PI and
Sub-Investigator(s) (SI) to determine participant eligibility based
on inclusion/exclusion criteria for each study. Coordinates proper
data management according to protocol requirements and compliance,
i.e. collect and record all data pertaining to study patients on
specific study. Enters data into designated electronic data capture
within 72 hours. Provides database support (design, implement,
update and review for integrity). Responsible for meticulous and
careful data management of studies: abstraction; timely submission
of data forms; retrieval of data, clinic visits; and maintenance of
neat case files. Manages monitoring visits with sponsor. Submits
amendments, continuing reviews, modifications for IRB applications
and other regulatory documents as needed. Tracks approvals for
projects. Ensures all personnel have proper certifications.
Responsible for timely and accurate IRB applications, and
- Participates in all study related conference calls and research
group meetings. Provides back-up coverage for the 24-hour research
contact line and triages to the appropriate staff member. Assists
in the onboarding process and training of new CRNC. Performs
special projects for the Director of Clinical Research, Financial
and Regulatory Manager, and Senior Leadership as needed. Other
duties as required.
- Organizes, plans, and manages time effectively
- Completes all mandatory training as required
- Attends staff meetings as required
- Meets position requirements and performs essential
- Performs other duties as assignedExpectations of all
Employees:Quality and Customer Satisfaction:
- Demonstrates commitment to superior customer experiences with a
- Collaborates with others to coordinate care, resolve concerns,
and address the needs of patients, family members, physicians, and
employees. Interpersonal Skills:
- Always communicates professionally and appropriately.
- Maintains a positive and respectful attitude with all
- Demonstrates behaviors that support and uphold CPA's purpose to
nurture and champion the health of all children and their families
by acting as compassionate, relentless advocate for every patient
and family member.Accountability and Productivity:
- Adheres to all CPA's Policies and Procedures
- Consistently reports to work on time and prepared to perform
duties of the position
- Accepts responsibility for decisions and actions
- Adheres to regulatory and company policies and procedures.
- Respects and considers patient rights to privacy and complies
with all HIPAA guidelines for maintaining confidentiality.
- Compliance with all OSHA, DHEC and Practice safety
- Valid LPN or RN license from the State of South Carolina
Minimum of a diploma from an accredited nursing school required;
Bachelor of Nursing or other Science degree preferred One (1) year
clinical nursing experience in a hospital, clinic or similar health
care setting preferred (bachelor's degree may be substituted for
one (1) year work experience) Clinical research experience
- CPR certification preferred
- Prior medical practice experience preferred.
- Working knowledge of computer applications. Prior experience
with EMR preferred.
- Ability to speak, read and write effectively.
- Ability to work independently without direct supervision.
- Ability to coordinate, analyze, observe, make decisions, and
meet deadlines, in a detail-oriented manner.
- Ability to work weekdays, evenings, and weekends. Physical
Requirements:The physical demands described here are representative
of those that must be met by an employee to successfully perform
the essential functions of this job.While performing the duties of
this job, the employee is regularly required to talk or hear. Must
have good visual acuity and ability to verbally communicate. The
employee frequently is required to stand; walk; use hands to
finger, handle or feel; and reach with hands and arms. The ability
to lift, lower, push, pull and retrieve objects weighing a minimum
5 lbs. frequently.Work Environment:
- Indoor, temperature controlled, smoke free environment.
Occasional outdoor exposure.
- Exposure or potential exposure to blood and bodily fluids may
- May at times work under stressful situations.
- ADA Compliant PI128260881
Keywords: Coastal Pediatric Associates, Charleston , Clinical Research Nurse Coordinator, Healthcare , Charleston, South Carolina
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