This role follows a hybrid work schedule, with a minimum requirement of 3 days onsite per week at our Los Angeles work location. Applicants must be able to meet this onsite requirement and, if hired, must reside within a commutable distance of the work location.
Join a supportive, collaborative team contributing to NIH-funded studies with partners across multiple institutions. Responsibilities can be aligned with individual skills and interests, with opportunities to grow into new areas as projects evolve. Team members may also have opportunities to contribute to or lead manuscripts, abstracts, and conference presentations.
The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
- Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
- Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
- Schedules and participates in monitoring and auditing activities.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (Google Cloud Platform) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
The ideal candidate will have experience with data cleaning and REDCap database design and monitoring. Experience supporting behavioral research is preferred.
Education
- High School Diploma/GED - minimum
- Bachelor\'s Degree Science, Sociology or related degree - preferred
Experience
- 1 year Clinical research related experience - minimum
Licenses and Certifications
- No license or certification required - minimum
- Certification In Clinical Research - Upon Hire preferred SOCRA or ACRP certification
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