Clinical Research Data Coord.
Spartanburg Regional Medical Center
Job Requirements Position SummaryClinical Research Data Coordinator assumes responsibility for the overall data coordination of oncology research trials. This position will be responsible for obtaining research data and entering data in the Electronic Data Capture (EDC) for complex interventional therapeutic and supportive care trials including but not limited to industry and cooperative group studies. Ensures data from source is entered in EDC per Sponsor contract expectations if not sooner. Facilitates study monitoring visits and prompt resolution of all study related queries. Responsible for coordinating with patients, participating physicians, clinical research coordinators, quality, regulatory and study sponsor to ensure data integrity. Support processing and shipping of biospecimens. Must be self-starter/motivated, detail-oriented, willing to develop the clinical research service line within the oncology program. Willing to learn and train on required clinical research database and clinical trial management system. Minimum Requirements EducationBachelor's degree and one year of clinical experienceAssociate degree with minimum of three years clinical experienceORCurrent certification in clinical research (SOCRA-CCRP, ACRP-CCRC or ACRP-CP) with five years clinical experience Experience• See aboveLicense/Registration/Certifications N/APreferred RequirementsPreferred Education• Bachelor or Masters in a Heath Related field Preferred Experience• Knowledge of clinical data and Good Clinical Practices; knowledge of medical terminology• One (1) year oncology experience• Clinical research experience• Phlebotomy experiencePreferred License/Registration/Certifications • Certification in research (CCRC, CCRP)Core Job ResponsibilitiesReviewing medical records: Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocolsEntering Data: Entering data into data bases and forms, ensuring data is entered into the database in a timely and accurate mannerContacting sources: Contacting physicians, patients, and other sources to obtain follow-up information on missing dataMaintaining logs: Maintaining screening and enrollment logs and tracking patient progressRecord Maintenance: Collects and maintains complete records and metrics on each research study participantMonitoring Compliance: Monitoring protocol compliance and reporting instances of noncompliance Biospecimens: Processing, shipping, and tracking of biospecimens for researchAttends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query managementAttends protocol related training meetings and completes all required study trainingSupports efforts in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research dataSupports preparation for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post auditMust be able to work as a team member with other Research staff, doctors, departments, community, and other componentsAssures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies Maintains controls to assure accuracy, completeness, and confidentiality of research dataMust have own transportation to other hospitals and doctors' officesMust be flexible in responsibilities and work scheduleMust be meticulous with detailMust be able to read, write, and speak English fluentlyMust have good communication skillsMust be able to respond calmly and efficiently in high stress situationsMust be able to sit for long periods of time, filling out paperworkMust be self-directed and able to work without supervisorPerforms other duties as assignedJob SummaryJob number: P-107878Profession: Clinical Research Careers
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