Job Details

Location: Los Angeles, CA

Essential Job Responsibilities :

• Manages the study activation process for all cancer trials, which includes the following cores: study activation, regulatory, protocol review and monitoring systems (PRMS), and others as assigned.
• Develop staffing models, policies and processes for standardization of cancer clinical trials within assigned cores. Develops systems to manage the inter dependency between the projects, and communicates the vision and objectives to teams.
• Continuously assesses and measures outcomes and makes adjustments as necessary.
• Coordinate staff and administrative process for multiple investigators, including IRB submissions, institutional documentation, progress reporting to sponsors, ensuring accurate case reports, and staff workload delegation.
• Utilizes critical thinking, problem solving, and functions as appropriate to allocate and optimize resources across all of the constituent projects to ensure goals are met and on target.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
• Works closely with investigators to constantly monitor processes related to research operations and maximize research potential.
• Meets regularly with faculty and staff to discuss protocols, priorities and procedures.
• Meets with department management to provide feedback and coordinate efforts for improvement.
• Assures excellent conduct of multiple clinical trials by providing expertise for faculty and oversight and expertise for study staff.
• Assures activities of the CRO are in line with the guidelines of the CCSG grant.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance; provides oversight to project planning, project logistics, and leads project implementation.
• Directly manages staff within study activation cores and provides on-site and day-to-day oversight of staff and operational activities. Ensures adequate tracking mechanisms for study activation work streams and time/effort reporting and produces productivity and metric reports as appropriate or upon request.
• May collaborate with research informatics for system support to carry out goals and objectives
• Develops routine quality assurance checks for assigned cores and implement appropriate checks/balance systems and/or monitor ongoing complianceImplements and continuously refines role specific training and education program for existing staff and new employees (study activation, regulatory and PDC) .
• Assess policies and procedures to ensure optimal operations and assists in development and/or implementation of process improvement plans within assigned coresInitiates and maintains collaborative relationships between inter-departments (i.e. IRB, SRFA) to streamline processes and maximize resources .
• Meets with external monitors and/or auditors to ensure satisfactory trial conduct and represents the medical center during these meetingsWorks closely with training and education lead to build processes to complement the new employee on boarding process by developing specific modules for cores under direct management .
• Serves as SOCCI FDA expert and responsible for all FDA correspondence and Supports investigators by providing oversight of all FDA submission to ensure compliance with federal regulations for institutionally/PI held INDs .
• Work with leadership to develop process for study activation: developing process workflows, manuals, standard protocol language, forms, worksheets, instructions and tools, tracking and compliance monitoring tools, establishing templates, guidance documents and SOPs.
• Understand the organizational strategy, and as that shifts present, adjusts the program and the projects that are the building blocks to success to match the new goals.
• Oversees staff and projects within the protocol development core ore and study activation of all cancer protocols.
• Responsible for developing processes and standards and quality tracking for clinicaltrials.gov and clinical trials reporting program (CTRP) and overseeing staff who manage individual registrations for IITs.
• May develop material/or conduct PI/Staff training sessions in specific areas, present or/prepare productivity/metric/quality reports internally or externally as needed .
• Provides consultation to outside groups for regulatory and PDC mattersActively participates in clinical trial initiatives or special interest groups within National Groups (i.e. AACI, DIA) and contributes ideas and/or serves on task force, committees or in special projects that allow .
• COMPANY to have national presence and capitalize on the collaborative efforts of such groups Monitor emerging trends regarding industry regulations to establish potential impacts on organizational processes .
• May be asked to comment on strategic development, prepare SWOT analysis, SBAR or other like proposalsMay participate in educational lectures outside of SOCCI/CSMC .
• Responsible for specific department projects as assigned Business Entity: CSMC - COMPANY-Sinai Medical Center Education BA/BS required.
• Masters degree strongly preferred Certification / License ACRP/SoCRA/RAPS (or equivalent) certification preferred.
• ExperienceTen years experience in an academic clinical research setting, with 3-5 years direct supervision/managerial responsibility and oncology experience preferred.

Department-specific experience :

Minimum of 5 years of Oncology Therapeutic Clinical Trial experience.Educational And Work Experience PreferencesPhysical Requirements (physical abilities essential to perform the job)Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.