CLINICAL RESEARCH DATA COORDINATOR I (Clinical Trials Office) Multiple Positions Available

Company: CTI Education Group
Location: San Diego
Posted on: February 23, 2021

Job Description:

Job Description - CLINICAL RESEARCH DATA COORDINATOR I (Clinical Trials Office) Multiple Positions Available (T181716) CLINICAL RESEARCH DATA COORDINATOR I (Clinical Trials Office) Multiple Positions Available - ( T181716 ) To collect data and enter it in accordance with established procedures. To perform routine analyses and prepare reports in prescribed format. To provide data management support. Clinical Research Data Coordinator will support principal investigators and the clinical trials operational team with administrative, data collection and entry in the management to support the day-to-day execution of clinical trials from start up to close out; ensure adherence to compliance with established SOPs, GCP, IRB, FDA, and other applicable regulatory requirements in the execution of clinical trials. Works independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Accurately captures in a timely manner, subject information into various study specific data capture systems (electronic and paper). Requires knowledge of various disease states and the ability to determine the appropriate clinical information to report. Information reviewed may include, but is not limited to treatment records, clinical and radiographic evaluations, diagnostic test results, records of surgery, and pathology information. Utilizes systems for controlling the data flow for clinical trials. Obtains required forms, slides, reports, and other pertinent information required for subject eligibility analysisAssists in analysis and quality assurance of clinical trial research information: Coordinates routine monitoring and audits with industry sponsor pharmaceutical representative or clinical research organizations. Coordinates preparation of data for audits and monitoring visits. Provides sufficient, appropriate, and timely responses to sponsor verbal and written queries.Attends protocol specific training including but not limited to Study Investigator's Meeting, Study Initiation, and Study Start up. Participate in conference calls and/or meetings with vendors. Attends approved off-site meetings and conferences. Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the clinical trial process, including but not limited to eligibility and disease processes. Attends weekly CTO meetings, participates in training and educational opportunities. Perform other duties as assigned.-- (Hourly Pay Rate: $14.84 - $23.36)-- High School diploma or GED required.-- Preferred Skills/Experience:
Clinical trial research, knowledge of applicable clinical research data collection requirements; including GCP and ICH guidelines. Strong clinical data entry skills. Familiar with patient records and documentation. Strong background using medical terminology. Exposure to patient care in hospital or outpatient setting. Oncology or general medical background. Familiar with patient records and documentation. Strong background using medical terminology. Experience reading charts and extracting information. Experience as part of a medical team. Strong communication and relationship building skills.--

Keywords: CTI Education Group, San Diego , CLINICAL RESEARCH DATA COORDINATOR I (Clinical Trials Office) Multiple Positions Available, Administration, Clerical , San Diego, California