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Clinical Research Nurse Coordinator

Company: Coastal Pediatric Associates
Location: Charleston
Posted on: January 9, 2021

Job Description:

Description:
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 responsiveness.
    • 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 functions
    • Performs other duties as assignedExpectations of all Employees:Quality and Customer Satisfaction:
      • Demonstrates commitment to superior customer experiences with a service-oriented attitude.
      • 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 work-related contacts
        • 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 standards.

            Requirements:
            Qualifications:
            • 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 preferred
              • 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 be required.
                • 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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