Clinical Research Data Coordinator

Clinical Research Data Coordinator About City of Hope, City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope's uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. The successful candidate: The Clinical Research Data Coordinator will build and maintain data standards for all clinical trials, and assist with study start up including protocol review, case report form and database review; dataset specifications, data transfer specifications, and review of data management and handling plans. Additionally will develop and implement the data correction process, discrepancy resolution, data control activities, and data validation with source documents. Will support clinical trial studies from preparation through closeout including regulatory submissions by standardizing data management. Ensure source documentation and management of clinical study data is in accordance with FDA regulations and ICH/GCP guidelines Attend all SIVs and Monitor visits Enter data in the CTMS and provide weekly/monthly enrollment reports. Job Responsibilities 65%| Perform abstraction and data entry from various sources to support all research studies. 25%| Work with providers/coordinators to identify and address data discrepancies and queries. Liaison between sponsored trial monitors and provider/coordinators. 10%| Work with providers to identify data points to answer queries and perform query function to export data requests. Perform quality assurance checks to ensure the accuracy of data entered. Skills, Education and Additional Information Knowledge of or ability to learn medical/oncology terminology and experience using Microsoft Access and Excel or EDC systems to include Inform, TrialManager, Medidata and RedCap. Minimum of an Associate Degree in life sciences or information systems with experience in the health field preferred. 2-3 years clinical/oncology experience preferred. Prioritizes work based on deadlines. Seeks clarification on data entry requirements from providers. Works directly with supervisor and providers to identify data points and answer queries. Ability to work independently and thrive in a results oriented environment City of Hope is an equal opportunity employer. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. Each of us at City of Hope believes in and is dedicated to turning hope into reality. Every researcher, nurse, doctor, administrative professional or IT specialist brings his or her unique creativity and talent to the fight against cancer, diabetes and other life-threatening illnesses. Whether your interest is in the clinical, business, science or support service area, at City of Hope you will collaborate with the best and brightest colleagues, be challenged by engaging tasks and impact the lives of many people.