Clinical Research Coordinator I
Department BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 1 About the Department The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies. Job Summary The Clinical Research Coordinator I provides support to the faculty of the Section of Hematology/Oncology within the Biological Sciences Division. The CRC1 will be involved in multiple research trials types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section.
Responsibilities
Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques. Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups. Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Accountable for all tasks in basic clinical studies. Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples. Performs other related work as needed.
Minimum Qualifications
Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through Apply tot his job Apply To this Job