Clinical Research Nurse - Pediatric Experience

Department: Operations

Employment Type: Full Time

Location: Charlottesville Medical Research Center | Charlottesville, VA

Description

Join us as we continue to grow, the Clinical Research Nurse works to ensure the execution of assigned studies, and performs clinical procedures, such as venipunctures, injections, prep or mixing of investigational study drugs and infusions, under the scope of the study protocol and in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Key Responsibilities

Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:

• Documenting and reporting adverse events;
• May set up, train and maintain all technology needed for studies.
• Reporting non-compliance to appropriate staff in timely manner;
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following hire.
• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
• Well-developed written and verbal communication skills.
• Must possess a high degree of integrity and dependability.
• A 401k plan with an employer safe harbor match is also offered, with enrollment eligibility being the first of the month following 30 days of employment.
• Filing SAE/Deviation reports to Sponsor and IRB as needed;
• Patient consents;
• Proficiency with performing clinical procedures such as injections, vitals, EKGs, phlebotomy, infusions, etc. is required.
• Entering data in EDC and answers queries;
• Conducting monitoring visits and resolves issues as needed in a timely manner;
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, and supplemental insurance are offered.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
• Screening of patients for study enrollment;
• Documenting in source clinic charts;
• Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
• Obtaining vital signs and ECGs;
• Patient follow-up visits;
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• Scheduling subjects for study visits and conducts appointment reminders;
• Performing all other duties as requested or assigned.
• Always practicing ALCOAC principles with all documentation;
• May assist with study recruitment, patient enrollment, and tracking as needed;
• Maintaining confidentiality of patients, customers and company information, and;
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• Maintaining & ordering study specific supplies;
• Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:
• Strong organizational skills and attention to detail.
• Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.
• Updating and maintaining logs, chart filings;
• Maintaining positive and effective communication with clients and team members;
• Building/updating source as needed;
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Requesting and tracking medical record requests;
• Ability to work under minimal supervision, identify problems and implement solutions.