Lead Research Coordinator for Mindfulness-Assisted Psychedelic TherapyApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA---Health-Sciences-Campus/Lead-Research-Coordinator-for-Mindfulness-Assisted-Psychedelic-Therapy\_REQ20158318/apply) Keck School of Medicine Los Angeles, California The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is. The successful candidate for this Research Coordinator II position will be a dynamic, motivated, highly organized individual who is experienced with clinical research and able to effectively communicate with the study’s investigators, staff, and participants. This role will be responsible for recruitment, participant tracking, data collection, and data management for the Mindfulness-assisted Psychedelic Therapy study, an interventional research study. In addition to clinical research experience and aptitude, enthusiasm for working in the domain of meditation and psychedelic therapy intervention is a high priority.Core responsibilitiesinclude working to recruit participants to a research study involving an investigational medication; overseeing day to day study activities; coordinating and running study sessions; creating data collection forms and maintaining the study database (REDCap); collecting and recording participant data; maintaining records so that all projects are compliant with institutional policies; communicating with physicians, scientists, and staff to coordinate study activities; and maintaining regulatory documents and communicating with internal and external regulatory agencies (IRB, FDA, etc) to ensure compliance with local, state, and national regulations. This research coordinator will report to the Principal Investigator and will oversee the work of the study’s Research Coordinator I. The successful candidate will have excellent organizational and interpersonal skills with the ability to interact with participants, physicians, researchers and a large multi-institutional network of collaborators. This person will regularly review responses to the eligibility survey on the study website to identify potentially eligible participants. The candidate should be comfortable interviewing participants and compassionate of the medical problems that the participants may be encountering. This person will participate in consenting research subjects to an interventional trial involving an investigational medication and will work with the investigators to ensure that all proper training is received, and all institutional regulatory protocols are followed. It is expected that the candidate will have a clear understanding of the inclusion/exclusion criteria for the study for which he/she is obtaining informed consent. This person will be involved in preparing study schedules, coordinating and running study sessions (with the assistance of the Research Coordinator I), collecting participant data and biological specimens, administering computerized cognitive tests, and obtaining EEG recordings. The candidate must have experience working with REDCap or similar software to create and maintain study records and perform quality assurance steps. Participant confidentially must be strictly protected at all times. The Research Coordinator II will coordinate with and assist the study physician and study therapists to complete sessions related to preparation, ingestion, and follow-up of the investigational drug, and will assist the study therapists with scheduling and monitoring attendance at group study sessions (mindfulness training). The candidate must have excellent organizational skills to manage complex schedules and ensure that study data is collected at the appropriate time according to study SOPs. The candidate must be able to manage biological specimen collection (blood, urine) following the approved IRB protocols and SOPs. They will be expected to have a phlebotomy license, or obtain one, so that they can collect blood samples according to study SOPs. All specimens received must be correctly logged using study numbers. This individual is responsible for coordinating timely receipt of blood specimens by lab members to ensure success of the study objectives. Individuals from those labs will assist in this endeavor, but the research coordinator must manage the coordination of these specimens as they pertain to the study. This candidate will be responsible for regulatory submissions including protocol amendments, progress reports, and other required reports to regulatory agencies including the FDA, the USC Institutional Review Board, and the California Research Advisory Panel. This position requires a high degree of organization and attention to detail. Prior experience with creating and maintaining regulatory documentation in a clinical research environment is required. The Research Coordinator II is expected to proactively address regulatory concerns and maintain compliance with all federal, state, and local policies regarding study conduct. This person will ensure that study enrollment data is up to date in the study database and present a coherent summary of accrual as well as highlighting any problems that occurred with any aspect of the research study. The research coordinator and the principal investigator shall meet weekly to discuss subject eligibility and study progress. As time allows, engaging in preprocessing, preliminary analysis of the data and writing up of the results will be a part of this position as well. Minimum Qualifications Minimum Education:Bachelor's degree Minimum Experience:2-3 years Minimum Field of Expertise:Experience with research coordination in clinical research. English language proficiency. Will be required to complete human subjects research training if not already completed. Excellent verbal and written communication skills and interpersonal skills. Strong knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPAA regulations. At least three years of experience in clinical research, including at least one year experience with creating and maintaining regulatory documentation for clinical research is required; experience with mental health research is desired. Excellent record keeping skills. Facile with computer data entry. Able to walk between our various clinical sites on the same campus, perhaps 2-3 miles per day. Comfortable working in a fast-paced environment. Knowledge of medical environment and terminology. Proficient with MS Office applications. Problem solving skills to successfully recruit subjects in a busy clinical environment. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. California phlebotomy license (Certified Phlebotomy Technician I) is a plus, or at least willingness to do such training for the purpose of the study. Preferred Qualifications Preferred Experience:3-5 years Supervises:No Special Instructions to Applicants: Applicant Attachments (Required):Résumé & Cover Letter Applicant Questions:N/A Position Details Fixed Term: 2 years with opportunity to extend depending on funding ­ The hourly rate range for this position is $34.52 - $39.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational consideration. The University of Southern California strongly values diversity and is committed to equal opportunity in employment. Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. Minimum Education: Bachelor's degree Minimum Experience: 2 years Minimum Skills: Administrative or research experience. Knowledge of medical environment and terminology. Knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPPA regulations. Proficient with MS Office applications. Demonstrated effective communication and writing skills. Ability to multi-task. Demonstrated ability to work as part of a team as well as independently. Preferred Experience: 3 years Preferred Skills: Staff education and orientation experience. Knowledge of Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS). REQ20158318 Posted Date: 01/22/2025