Santa Fe, New Mexico
Nashville, Tennessee
South Portland, Maine
New York, New York
Posted: 18-Jul-24
Location: Los Angeles, California
Salary: Open
Categories:
Internal Number: 140307863
The Data and Regulatory Coordinator is responsible for regulatory approvals and data entry support for studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.
Essential to this role is a close collaboration with the Principal Investigator (PI) of each study, to facilitate timely study progress reporting to the PI and enabling appropriate PI oversight. You will be responsible for data management, including prompt and accurate case report form (CRF) data entry and query resolution, biospecimen tracking, including oversight for collection, processing and shipping. You will work with Principal Investigators, Sub-Investigators, support staff, federal and state agencies, industry partners, and other collaborative departments to coordinate and manage investigator-initiated and sponsor-initiated clinical trials and research endeavors. You will drive processes to ensure that studies meet institutional operational research objectives as well as ethical obligations to research participants. In addition, you will be expected to assist with other research related projects, as assigned, and solve potential challenges collaboratively and with professionalism and determination.
Salary Range: $22.03-$43.68 Hourly
A bachelor's degree in Science or related fields or 2 Plus years of clinical research experience in an academic setting
Demonstrated working knowledge of current medical terminology to accurately read entries in patient charts and record accurately and timely, information into study records and other appropriate research data forms.
Demonstrated knowledge of "good clinical practices" for clinical research as defined by ICH.
Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.
Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information.
Demonstrated ability to prioritize workload to meet demands of Department, PI's, Sponsor and FDA.
Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., regulatory processes, data management, , etc.
Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.
