Newport Beach, CA, United States
Clinical Research, Pharmaceutical, Research, Healthcare, Nursing
The Clinical Research Coordinator (CRC) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The CRC provides 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 CRC ensures smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. This position reports to the Director of Clinical Research. The CRC is 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 CRC assists in developing a 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 assists 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. Reports to the Director of Clinical Research and works as a team member to support growth and vision of the Hoag Institute for Research and Education. If the CRC is designated responsibilities for Regulatory and Compliance Coordination, the duties are detailed below separately.
*Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants. *Designs, implements and manages a system for organizing, planning work flow related to all research study activities. Prepares and presents 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, check-lists 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's visits in accordance with study protocol. Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol. *Drafts or reviews template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language. *Discusses research study with potential research participants and answers 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 *Documents and reports 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 record 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 Visit, Routine Monitoring Visits, Close-out Visits and audits. Reviews study records and meets with site visit teams/monitors, the FDA, or other inspectors as designated by sponsor when required. Resolves queries generated from Sponsor or other monitoring/auditing reports. *Completes study Institutional Review Board submission application and ensures 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. *Works with Clinical Research Office administrative staff in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds. *Accommodates changes in workload within the department and demonstrates flexibility in accepting work assignments. Performs assignments as directed by Supervisor. *Perform other duties as assigned.
Regulatory and Compliance Coordination Essential Functions
If the CRC is requested to be responsible for Regulatory and Compliance Issues, he/she will have the following duties:
*Regulatory Submissions: Registers new clinical study in clinical trial data base. Reviews and performs quality control of all regulatory documents to include protocols, investigator brochures, informed consent forms, recruitment materials and investigator curriculum vitae and licensure, and protection of human subjects training requirements. Confirms Investigator privileging. Establishes and maintains Clinical Research Office Investigator and Clinical Research Central Files. Assists Investigators in preparation for sponsor or regulatory monitoring visits or audits, as needed. Participation in design and implementation of Hospital clinical research forms and templates as needed. Primary staff liaison to Institutional Review Board(s). Tracks study continuing renewal applications. *Research Compliance Analysis: Tracks submission and completion of administrative and financial research documents. Prepares application to Fiscal Intermediary for reimbursement approval. Monitors document completion and execution. Maintains administrative and financial files within Clinical Research Office. Researches regulatory compliance issues in federal, state and industry data bases. Tracks study continuing renewal applications. Participates in the revision and development of clinical research departmental and hospital policies. *Study Maintenance: maintains clinical research data worksheets, shared drive, the departmental Wave website, and clinical research files. Provides ongoing oversight of clinical trial regulatory documents and performs periodic study monitoring for regulatory and ICF compliance. *Investigator Coordination: Reviews and maintains Clinical Research Office records of Investigator qualification for research. Advises Investigators on sources of applicable regulatory statutes and guidelines. Receives and performs quality assurance review for completeness of all Investigator reported Serious Adverse Events. Routes appropriate SAE reports to IRB and Quality Management Office within regulatory requirements. *Staff Support: Assists with meeting coordination within Clinical Research Office. Drafts, revises and sends correspondence with Investigators, Hospital Administrators, sponsors and regulatory bodies. Maintains Hospital-wide data base of active and start-up studies as required. Performs analyses of study census data. Functions within Clinical Research Office team framework. Reviews IRB documents for completeness, consistency and accuracy. Supports immediate and long term goals of Clinical Research Program at Hoag Hospital. Provides staff support to Clinical Research Office staff meetings and Hospital-wide research planning committees, as required. Assists with External Visitor Policy and collecting and tracking documents for ‘outside' researchers.
Education, Training and Experience
Clinical Research Coordinator
*Must have AA degree or current ACRP or SoCRA Certification *Minimum 1 (one) year of Clinical Research Coordinator experience. *Patient coordination experience in complex clinical trial setting required (does not include Regulatory position). *Medical terminology 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.
Skills or Other Qualifications
Required: 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 required to interface between departments, other coordinators, investigators, medical records, and 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.
License and Certifications
Clinical Research Coordinator
Required: Holds current ACRP or SoCRA certificate (or complete within two years of hire)
Preferred: Nursing Degree in LVN or LPN
Website : http://www.hoag.org
For more than 60 years, Hoag Memorial Hospital Presbyterian has delivered a level of personalized care that is unsurpassed among Orange County’s health care providers. Since 1952, Hoag has served the local communities and continues its mission to provide the highest quality health care services through the core strategies of quality and service, people, physician partnerships, strategic growth, financial stewardship, community benefit and philanthropy. Hoag is a nonprofit regional health care delivery network in Orange County, California, consisting of two acute-care hospitals, nine urgent care centers, six health centers and a network of more than 1,500 physicians, 5,000 employees and 2,000 volunteers. More than 25,000 inpatients and 369,000 outpatients choose Hoag each year. Hoag offers a comprehensive blend of health care services that include five institutes providing specialized services in the following areas: cancer, heart and vascular, neurosciences, women’s health and orthopedics through Hoag’s affiliate Hoag Orthopedic Institute, which consists of an orthopedic hospital and two ambulatory surgical centers. Hoag is also fiercely committed to exploring and perfecting innovative treatment options, often being the first hospital in Orange County to offer new health advancements. Hoag is fully accredited by DNV and has ISO 9001 certification. Additionally, Hoag is a designated Magnet® hospital by the American Nurses Credentialing Center (ANCC), which is the most prestigious certification in nursing. In 2013, Hoag entered into an alliance with St. Joseph Health to further expand health care services in the Orange County community, known as St. Joseph Hoag Health. The St. Joseph Hoag Health network, which is also affiliated with CHOC Children’s, focuses on meeting the big challenges of health care today, including expanding access, improving wellness and preventive services, ensuring quality and developing more efficient methods in the delivery of care. Hoag has been named one of the Best Regional Hospitals in the U.S. News & World Report Metro Edition, andBecker’s Hospital Review named Hoag as one of the 2016 “100 Great Hospitals in America” – a designation Hoag has received four times. National Research Corporation has endorsed Hoag as Orange County’s most preferred hospital for the past 20 consecutive years and, for an unprecedented 20 years, residents of Orange County have chosen Hoag as one of the county’s best hospitals in a local newspaper survey.