BNL Health Inc.
Clinical Research Coordinator II
9 days ago
Los Angeles
Job Description Role Summary The Clinical Research Coordinator II (CRC II) will be responsible for the coordination and administration of multiple research studies. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Responsible for recruiting, screening, consenting, and enrolling patients in clinical trials. CRC II also coordinates and oversees the subject’s visits in accordance with the protocol requirements. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers. Works with faculty in development of investigator-initiated studies. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Trains new staff. Develops procedures related to clinical trial coordination. Acts as resource for the education and training of clinic staff as well as resource for problem solving complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs. Compiles and reports protocol activity; accrual data, and financial information. Interacts with study participants diagnosed with various medical conditions and diagnoses. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports. Assures site research quality by practicing in compliance with BNL Health, Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Works closely with Principal Investigators, the Research Staff, and the Clinical Staff, facilitating all aspects of assigned clinical trials. Must uphold the standards of confidentiality, attendance, and punctuality. Performs all duties in a manner which promotes team concept. Primary Duties and Responsibilities • Serve as the primary contact to ensure appropriate communications, trial management, and meeting of timelines., • Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, participating in the informed consent process, and scheduling patients for research visits and procedures., • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug, drug accountability, and protocol deviations., • Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries., • Ensure the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance., • 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., • Assure ongoing compliance with all system, regulatory, federal regulations, and department policies. Support & assist in all aspects of clinical data management, including creation, and collection of source documents, online clinical trials electronic data capture databases (e.g. Veeva, RedCap), completion of case report forms, and tracking/reporting of serious adverse events. Collects and maintains complete records and statistics on each research study patient., • Support and assist in the preparation of study documents such as study operating procedures manual, monitoring manual, laboratory manual, study protocols, informed consent and recruitment materials., • Assist with the submission of regulatory documents in accordance with IRB, federal, industry, and institutional guidelines and requirements., • Coordinate the collection and processing of biospecimens for research projects and clinical trials conducted within BNL Health. Arranges for review and submission of pathology materials and/or radiology materials as required per protocol, • Assist with and/ or oversees study activities including training other clinical trial support staff and assuring quality assurance of study activities and quality data. Provide current and accurate protocol resources to investigators and staff., • Attend investigators meetings/ various study related training and meetings., • Liaise with sponsors when applicable and coordinate study drug shipments and accountability. Set-up monitoring visits and addresses monitoring reports where applicable, • Assist with quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate, • Demonstrated proficiency organizing and maintaining study data within an electronic Clinical Trial Management System (CTMS), such as CRIO, Medidata Rave., • Must be able to travel between sites in Century City, CA and Torrance, CA on a regular basis to manage site activities Education Bachelor's Degree or equivalent education/ experience preferably in a scientific or health-related field, nursing qualification or relevant experience and have clinical research monitoring experience (including experience conducting prestudy, initiation, interim monitoring and closeout visits). Work Experience Dr. Lisa Cook M.D. has helped thousands of patients overcome chronic migraines, cognitive disorders, symptoms of CTE, seizures, and a wide variety of other neurological disorders. Finding a licensed and reputable Los Angeles neurologist can be a challenge. Dr. Lisa Cook is a board-certified Los Angeles neurologist that has been committed to providing excellent neurological to her community for close to a decade. Dr. Cook received her undergraduate and medical school degree at the accelerated 7-year medical program at the University of Illinois at Chicago. Then completed her Neurology residency and Clinical Neurophysiology fellowship at the University of Michigan in Ann Arbor, Michigan. She relocated to Los Angeles in 2009 and is enthusiastic in providing the utmost care to her patients. Dr. Cook is on staff at Cedars-Sinai and is actively involved in teaching residents and medical students in the Neurology stroke fellowship program. In addition, she is a part of the Cedars-Sinai stroke team and aggressively pursues stroke intervention in complex decision-making treatment for patients that qualify. This comprehensive stroke coverage includes Cedars Sinai Marina Del Rey Hospital and Torrance Memorial Hospital. She is also serving as the Neurology Director at Cedars-Sinai Marina Del Rey Hospital. Lastly, she is also currently working with NFL Concussion Settlement program and one of select MAF and BAP certified neurologists who is able to assess NFL players involved in the settlement due to concussion related injuries. Dr Andrew Blumenfeld is Director of The Headache Center of Southern California, San Diego; and co-Director of The Los Angeles Headache Center. He has offices in San Diego and Los Angeles. He is Board-certified in Neurology by the American Board of Psychiatry and Neurology, and is also certified in Headache Medicine. Dr Blumenfeld is a member and fellow of both the American Academy of Neurology and the American Headache Society. He is the founding chair of the American Headache Society section on Interventional Procedures for Headache. He has published widely and has over 100 peer review publications. One of his manuscripts was voted the top publication in the Headache journal. His research interests have focused on the use of Botox for migraine. He helped to develop the injection protocol used in the pivotal migraine trials and has injected more patients for this condition than any other provider in the world. He teaches other providers on this procedure nationally and internationally. He has been an active researcher in headache with over 10 issued patents for various treatments.BNL Health/The Los Angeles Headache \r\nBeing the best Los Angeles specialists & neurologists,\r\n\r\nDr. Lisa Cook M.D. has helped thousands of patients overcome chronic migraines, cognitive disorders, symptoms of CTE, seizures, and a wide variety of other neurological disorders. Finding a licensed and reputable Los Angeles neurologist can be a challenge. Dr. Lisa Cook is a board-certified Los Angeles neurologist that has been committed to providing excellent neurological to her community for close to a decade. Dr. Cook received her undergraduate and medical school degree at the accelerated 7-year medical program at the University of Illinois at Chicago. Then completed her Neurology residency and Clinical Neurophysiology fellowship at the University of Michigan in Ann Arbor, Michigan. She relocated to Los Angeles in 2009 and is enthusiastic in providing the utmost care to her patients. Dr. Cook is on staff at Cedars-Sinai and is actively involved in teaching residents and medical students in the Neurology stroke fellowship program. In addition, she is a part of the Cedars-Sinai stroke team and aggressively pursues stroke intervention in complex decision-making treatment for patients that qualify. This comprehensive stroke coverage includes Cedars Sinai Marina Del Rey Hospital and Torrance Memorial Hospital. She is also serving as the Neurology Director at Cedars-Sinai Marina Del Rey Hospital. Lastly, she is also currently working with NFL Concussion Settlement program and one of select MAF and BAP certified neurologists who is able to assess NFL players involved in the settlement due to concussion related injuries.\r\n\r\nDr Andrew Blumenfeld is Director of The Headache Center of Southern California, San Diego; and co-Director of The Los Angeles Headache Center. He has offices in San Diego and Los Angeles. He is Board-certified in Neurology by the American Board of Psychiatry and Neurology, and is also certified in Headache Medicine. Dr Blumenfeld is a member and fellow of both the American Academy of Neurology and the American Headache Society. He is the founding chair of the American Headache Society section on Interventional Procedures for Headache. He has published widely and has over 100 peer review publications. One of his manuscripts was voted the top publication in the Headache journal. His research interests have focused on the use of Botox for migraine. He helped to develop the injection protocol used in the pivotal migraine trials and has injected more patients for this condition than any other provider in the world. He teaches other providers on this procedure nationally and internationally. He has been an active researcher in headache with over 10 issued patents for various treatments.