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Novant Health · 14 hours ago

RN Clinical Research Coordinator

Wilmington, NC

Full-time

Hybrid

Entry, Mid Level

1+ years exp

Novant Health is a healthcare organization that is seeking an RN Clinical Research Coordinator to facilitate and coordinate daily clinical trial activities. The role involves ensuring compliance with regulatory requirements, communicating with study participants, and managing clinical trial data while demonstrating knowledge of clinical research concepts.

FitnessHealth CareHospitalMedical

Responsibilities

Sets up and performs routine clinical trial related activities. Collects, enters and summarizes clinical trial data. Monitor patients, their results, detects and reports all events per protocol, applicable policies and applicable regulations

Participate in or lead the day-to-day operations for all clinical research activity and study subject care

Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH). Assures regulatory submissions for all protocols, adverse events, revisions, renewals, and terminations

Communicates protocol information (through meetings, presentations, etc.) to physicians and staff. Read and understand clinical research protocols, informed consent documents and related materials. Assists in verifying patient history and medical information to assure appropriate enrollment in clinical trials. Confers with prospective study subjects to obtain informed consent as delegated by principal investigator. Schedules and attends patient visits. Perform protocol driven procedures as required and per licensure. Troubleshoots enrollment and study conduct issues. Maintains clinical and professional competency standards

Generates study specific source documents (paper and/or electronic) for use in clinical trial data collection. Collects blood samples, cultures, tissues and other samples for processing, shipping and or analysis. Collects and process information from patient charts, medical records, interviews and appropriate forms. Assesses and reports adverse events in a timely manner. Maintains protocol defined timelines and department guidelines. Completes study specific case report forms, electronic data capture systems and assures appropriate communication with study sponsors. Arranges and attends monitoring visits. Works with Sr. team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. With leader or senior team member guidance, coordinates scheduling of pre-site, initiation, monitoring and closeout visits. Assures drug and device accountability is up to date and available at all times

Qualification

Current RN licensureClinical Research CertificationClinical research experienceClinical Practice (GCP)Information Systems knowledgeHuman relations skillsAttention to detailVerbal communication skillsWritten communication skillsTime management skillsProblem-solving skills

Required

Only Registered Nurses will be considered for this position

Education: High School Diploma or GED, required

Graduate from an accredited school of nursing, required

Experience: Minimum of 1 year of nursing or clinical research experience required (CRA, Regulatory, clinic, floor, CRO, pharma/biotech/device company, or other related). Associate's degree may substitute for 1 year of experience or Bachelor's degree may substitute for 2 years of experience; Master's degree may substitute for 3 years of experience, required

Licensure/Certification: Current RN licensure in appropriate state, required

Requires demonstrated knowledge of complex clinical research concepts gained through education and experience

Works with a high degree of independence, using discretion and independent judgement in the executions of tasks

Human relations and interpersonal skills necessary for interacting patients and team members

Attention to detail and accuracy necessary

Ability and willingness to work irregular hours as necessitated by research protocols

Excellent verbal and written communication skills

Excellent telephone diplomacy

Working knowledge of Information Systems and database management

Excellent analytical and time management skills

Self-motivated and able to work independently as well as a team

Ability to prioritize and problem-solving skills, with demonstrated competency in applying clinical knowledge to patient management

Able to meet multiple deadlines for concurrent projects

Knowledge and assessment skills to provide age-appropriate care and protocol requirements

Preferred

RN's with experience working in Oncology, Clinical Research or Acute Care preferred

4 Year / Bachelors Degree, preferred

Clinical Research Certification, preferred

Good Clinical Practice (GCP), Human Subjects Training, and International Air Transportation Association (IATA) certification for shipping hazardous and biological substances

Certification in research