Clinical Trial Coordinator at Balt in Irvine, CA

Summary: Balt is a rapidly growing pioneer in the medical devices field, dedicated to improving the lives of patients. The Clinical Trial Coordinator will manage trial documentation, support budget negotiations, and serve as a liaison for study devices, ensuring compliance with regulations and efficient project execution. Responsibilities: - Provides Trial Management Filing (TMF) system support, including document inspection, filing, and auditing - Supports study budget negotiation and contract finalization related to any study providers, scientific committee members and investigator sites, and other contracts as required - Serves as key facilitator and liaison for shipping, receiving, and management of study devices, and other equipment - Responsible for reviewing, processing, and tracking of study invoices - Manages study and site materials, including, but not limited to study binders, study trackers, training documentation - Reviews informed consents for essential elements and completes applicable documentation - Provide support with documentation reconciliation to demonstrate that projects are run according to SOPs and regulations - Provide feedback for processes which need updating and documenting to the direct line manager - Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate - May provide study monitoring support to study sites, as needed - Performs other duties as required Required Qualifications: - Analytical - Ability to support analysis of diverse information; collects research data; uses results and experience to inform the appropriate functions regarding product specific direction (as appropriate) - Design - Generates creative solutions; demonstrates attention to detail - Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations - Organizational Support - Supports organization's goals and values - Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments - Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas - Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Independently motivated - Demonstrated ability to manage multiple global complex clinical projects - Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions. Ability to develop good interpersonal relationships with medical professionals. Good presentation skills - Written Communication - Writes clearly and informatively; presents data effectively and accurately - Bachelor's-level degree required - 1-3 years' experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials - Required in-office support in Irvine, CA (must live within driving distance of Irvine, California Balt location) - ~20% domestic travel Preferred Qualifications: - Degree in science/health related field (e.g., Biology, Nursing, Biomedical, Pharmacy or Veterinary Sciences) preferred Required Skills: Trial Management Filing (TMF) system, Study budget negotiation, Contract finalization, Study monitoring, Clinical trials, Clinical project management