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CLINICAL RESEARCH COORDINATOR - CLINICAL RESEARCH DIABETES
Newport Beach, CA Reporting to the Director, of Clinical Research, the Clinical Research Coordinators (CRC) are responsible for all aspects of clinical research activities and work in close cooperation with study physicians. The CRCs provide support, coordination, and leadership for FDA-regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials, government-funded clinical research, and investigator-initiated clinical research. The CRCs ensure the smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. The CRCs are involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects. The CRCs assist in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assisting with monitoring, auditing, and close-out visits. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. ESSENTIAL FUNCTIONS: *Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensure the safety and welfare of the research participants. *Designs, implements and manages a system for organizing, and planning workflow related to all research study activities. Prepares and presents a summary of clinical trial activities if needed. *Be knowledgeable of study protocols to complete study activities correctly and completely. Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice. Develops forms, checklists, and other tools to facilitate study completion and compliance. *Assist the PI in the active recruitment and screening of potential research participants according to the protocol's inclusion/exclusion criteria. Schedule research participant visits in accordance with the study protocol. Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol. *Draft or review template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines, and **MEMBERS ONLY**SIGN UP NOW*** Policy language. *Discuss the research study with potential research participants and answer any questions while coordinating the process of obtaining the research subjects informed consent prior to participation in the study. . The CRC shall seek guidance from the Principal Investigator for any questions he/she cannot accurately answer for the research participant regarding the study or participant's medical condition. *Schedule or assist in scheduling follow-up visits for enrolled subjects *Document and report Unanticipated Problems, Adverse Events, and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH, and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB. *Complete the Case Report Forms for the study accurately and completely. Abstract data from hospital records and physician charts to complete CRFs. *Work with ancillary staff areas (e.g. Operating Nursing Care, Cath Lab, Pharmacy, Pathology, Radiology, Laboratory, Medical Records) within the hospital affected by research activities. *Maintain accurate and complete records of the receipt, dispensing, and return of all investigational supplies, including study drug(s) or devices, and report any discrepancies to the PI and Sponsor. *Maintain required regulatory and other documentation in the study documentation file. Maintain records of research participants enrolled in the study. *Communicate with the study sponsor regarding study activities as necessary. Participates in required study visits such as Initiation visits, Routine Monitoring Visits, Close-out visits, and audits. Reviews study records and meet with site visit teams/monitors, the FDA, or other inspectors as designated by the sponsor when required. Resolves queries generated from Sponsor or other monitoring/auditing reports. *Complete study Institutional Review Board submission application and ensure Investigator's review. Communicate with the designated IRB on study approvals/closures, and adverse event reporting *Work with the Clinical Research Office (CRO) administrative staff on all required aspects of study submission, continuing reviews, adverse event reporting, and study closure. Maintains current knowledge of Clinical Research Policies and Procedures. *Work with Clinical Research Office administrative staff in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds. *Accommodate changes in workload within the department and demonstrate flexibility in accepting work assignments. Performs assignments as directed by Supervisor. *Perform other duties as assigned. IN ADDITION TO THE ABOVE, THE SR. CLINICAL RESEARCH COORDINATOR WILL BE RESPONSIBLE FOR THE FOLLOWING: *Work with Director of Clinical Research and Cancer Institute leadership, including USC, to operationalize and maintain operations for Phase 1 research. Operations include equipment, staff training, space setup, and compliance *Work with Cancer Center Leadership to manage expenditures for research within the Cancer Institute *Coordinate with USC, Cancer Center, and other **MEMBERS ONLY**SIGN UP NOW*** staff, as appropriate, for setting up new research studies, including Phase I research, such as Clinical Outpatient Treatment Center (COTC) nursing staff, pharmacy, laboratory, research coordinators *Maintain all contracts for research with USC and work with Clinical Research Financial Specialist to execute invoices and payments as outlined in agreements *Work with USC staff including the Cancer Clinical Investigations Support Office (CISO) to activate new and maintain ongoing research studies associated with USC including but not limited to IRB processes, USC systems (Café, iStar, etc.), pertinent informed consent language, etc. *Regularly communicates updates and status of cancer studies to the Director of Clinical Research and appropriate medical staff, cancer research staff, and other team members *Work with Director of Clinical Research and Cancer Institute Leadership to develop and optimize processes between USC and **MEMBERS ONLY**SIGN UP NOW***. EDUCATION, TRAINING, AND EXPERIENCE: REQUIRED: *Patient coordination experience in complex clinical trial settings required (does not include Regulatory position). *Medical terminology is required. *Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. Understanding of clinical trial methodologies and experience filing Institutional Review Board documents. *Knowledge in one assigned clinical area *Bachelor's Degree or current ACRP or SoCRA Certification *Minimum 2 (two) years of Clinical Research Coordinator experience. SKILLS OR OTHER QUALIFICATIONS: REQUIRED: *The high degree of attention to detail and ability to follow instructions. *Good writing, oral, and presentation communication skills. *Works well independently. *Maintains subject and appropriate study-related material confidentiality. * Effective interpersonal skills are required to interface between departments, other coordinators, investigators, medical records, and the Institutional Review Committee. *Computer knowledge in Microsoft Windows applications including Word, Outlook, and Excel, and familiarity with electronic data capture systems preferred. *Ability to be proficient at additional specialized software and systems required. Position Reports to Director of Clinical Research |
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