Sr. Research Associate
 Ampcus, Inc | |
 United States, California, Los Angeles | |
 Nov 09, 2024 | |
|
Assist Principal Investigator, study coordinator, and team members in protocol review and study preparation, to ensure that study is sound from a regulatory and operational point of view.
Act as the primary liaison between Principal Investigator, Senior Management, study team, sponsor, regulatory agencies/committees, Investigational Drug Services (IDS) Pharmacy, and appropriate departments (Laboratory, Radiology, Pathology, Cardiology, CTRC, etc.) in discussion of study requirements With input from the Principal Investigator and study team, prepare and complete the appropriate regulatory documents for submission to the appropriate regulatory agencies/committees in order to obtain study approval Prepare and maintain study-specific regulatory files (binders) with all appropriate study-specific documentation. Assist with the preparation of study initiation presentation materials for Investigator Initiated studies and Sponsored studies if required, including protocol, IB, study source documents, CRFs, slides, study handouts, overhead presentations, and lab and procedure manuals. Assist team with ensuring that all study team members and/or satellite sites have received the materials prior to study initiation events (teleconferences and/or meetings). Attend study initiation meetings, and participate in study initiation and staff training events (teleconferences and/or meetings) for on-campus clinics, and satellite sites. Assist study team with training and orientation of treatment staff regarding protocol requirements. Ensure that all approvals (contract, ISPRC, MRSC and IRB) required for study activation occur. Notify the study team to begin enrollment upon receiving approval from Sponsor and verifying the study is in Care Connect. Uploading all study specific documents (Protocol, IB, ICF and patient materials) into the clinical research management system (CRMS) for study team use. Updating study status in CRMS to reflect activation for main campus and all participating satellite sites. Coordinate training teleconferences for staff unable to attend the study initiation meeting. Track study start-up times, create processes to decrease them, set goals and apply metrics to measure outcomes. Report directly to the Executive Committee with results and recommendations for further improvements. Develop, maintain and modify Standard Operating Procedures designed to ensure efficient and effective compliance with Data Safety Monitoring Board and FDA rules, such as maintaining training requirements and meeting reporting deadlines. These SOPs will be followed by the clinical trials unit. Analyze protocol and ensure that procedures are in line with Coverage Analysis directives, and advise Principal Investigator on recommend solutions as required. Align informed consent document with these directives. Required Skills/Experience: Regulatory clinical research experience Flexibility Able to multitask and prioritize competing deadlines Preferred Skills/Experience Dynamic Proactive Attention to detail | |