Grow your career at Cedars-Sinai! The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care.
We are committed to bringing innovative therapeutic options to all our patients with cancer. Join our team and contribute to groundbreaking research. The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department.
This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all applicable regulatory requirements. Establishes and completes logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
Coordinates administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE’s and source documents. Responsible for screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
Responsible for accurate and timely data collection, documentation, entry and reporting, including resolution of queries from sponsors or regulatory entities. Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions. 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.
Responsible for timely submission of adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. Plans and coordinates strategies for growing research participant enrollment, and/or improving clinical research efficiency as needed.
Provides technical support for the preparation of grant proposals, publications, presentations and special projects. Provides assistance with research project budget development, including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation. Participate in meetings and conferences related to research activities, including research staff meetings.
Participate in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as vital or requested; Participates in training and education of new research personnel. Perform accurate processing of research laboratory specimens while demonstrating an advanced degree of proficiency and understanding of research protocol and laboratory procedures, including centrifuging, aliquoting, storing, and shipping of specimens.
Monitor deliveries from sponsor, including inventory of kits, unpacking, and storing of supplies, and utilizing kits and supplies appropriately for specimen collection, processing, storage, and shipping, as mandated by sponsor. Maintain electronic record of supplies. Participate in monitoring and auditing activities to ensure compliance, including proposal of solutions to technical issues and subsequent implementation of corrective actions.
Educational
Associates Degree/College Diploma required Bachelor's Degree preferred Licenses/Certification: Basic Life Support (BLS) from the American Heart Association required (BLS expiration date must be valid 60 days from the start date) SoCRA or ACRP certification preferred
3 years of clinical research coordination or related experience. #Jobs-Indeed #LI-LA2