Clinical Research Coordinator I (Office - Based) - NCR
Novella Clinical is looking for experienced Clinical Research Coordinators who have (preferably) Oncology experience with clinical trials. This position is located in Winston Salem, NC.
Title: Clinical Research Coordinator I-II
The Clinical Research Coordinator will deliver the most remarkable patient experience, in every dimension, every time, and understand how he or she contributes to the health system’s vision of achieving that commitment to patients and families. The Clinical Research Coordinator will participate in clinical research studies in support of activities that meet the objectives of the assigned protocols.
Education: Bachelor’s degree in biological or clinical sciences or equivalent combination of experience
Experience: Two years’ experience in clinical research Preferred
Licensure/Certification/Registration: Professional certification in research Required
Current RN License in North Carolina
Additional Skills Required:
Human relations and interpersonal skills necessary for interacting patients and staff. 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.
Additional Skills Preferred: Good Clinical Practice (GCP), Human Subjects Training, and International Air Transportation Association (IATA) certification for shipping hazardous and biological substances.
Clinical Research and Protocol: If Applicable: Exercise authority and accepts accountability for all research activity and study participant care. Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB). 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. Troubleshoots enrollment and study conduct issues. Maintains clinical and professional competency standards
Process: Generates study specific source documents for use in clinical trial data collection. Collects blood samples, cultures, tissues and other samples for analysis. Collects and process information from patient charts, medical records, interviews and appropriate forms. Assesses and reports adverse events in a timely manner. Completes study specific case report forms and assures appropriate communication with study sponsors. Arranges and attends monitoring visits. Prepares for and attends sponsor and/or FDA audits. Screens incoming research proposals for feasibility. Coordinates scheduling of pre-site, initiation, monitoring and closeout visits. Acts as preceptor and trainer for coordinator staff in keeping with guidelines. Assures drug and device accountability.
Liaison: Attends study specific investigator meetings as required. Acts as liaison between study investigators, primary care providers, the institutional review board, study sponsors and staff to assure study flow and research integrity.
EEO Minorities/Females/Protected Veterans/Disabled
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