Clinical Research Coordinator I (Part-Time) - Pacific Heart Institute at CEDARS-SINAI summary: The Clinical Research Coordinator I supports and manages clinical research protocols at the Pacific Heart Institute, ensuring compliance with regulatory requirements and facilitating patient recruitment and data collection. This role involves coordinating with investigators, staff, sponsors, and regulatory bodies to maintain study integrity and patient safety. The coordinator also handles administrative tasks, reporting, and research finance billing in support of clinical trials. Job DescriptionAre you ready to be a part of breakthrough research?The Clinical Research Coordinator I supports clinical research protocols for the department. The Clinical Research Coordinator will assist the Research Department with all aspects of clinical research. 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 regulatory requirements.Primary Duties and Responsibilities:Responsible for 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.Facilitates 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.Coordinates 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.Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.Schedules and participates in monitoring and auditing activities to ensure compliance, including implementing any 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.Works closely with investigators and regulatory staff or directly with Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.Acts as a liaison with pharmaceutical company representatives or other project funding organizations to monitor and update project progress.Provides assistance with research finance billing, including identifying and classifying routine care vs. research related care.Attends meetings and conferences related to research activities, including research staff meetings.Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as necessary or requested.QualificationsEducation:High School Diploma/GED is required. An Associate Degree/College Diploma is preferred.Licenses and Certifications:Basic Life Support (BLS) is required.Certification in clinical research (SoCRA or ACRP certification) is preferred.Experience and Skills:Six (6) months of healthcare related or research experience is required. One (1) year of clinical research coordination is preferred.Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).Establishes effective working relationships with cross-functional team(s).Collaborates to solve problems and make decisions to achieve desired outcomes.Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.Identifies and responds appropriately to internal and external customer needs utilizing available resources.Represents the company with external constituents.About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.About the TeamWith a growing number of primary urgent and specialty care locations across Southern California, Cedars-Sinai’s medical network serves people near where they live. Delivering coordinated, compassionate healthcare you can join our network of clinicians and physicians to improve the healthcare people throughout Los Angeles and beyond.Req ID : 11435Working Title : Clinical Research Coordinator I (Part-Time) - Pacific Heart InstituteDepartment : Pacific HeartBusiness Entity : Cedars-Sinai Medical Care FoundationJob Category : Academic / ResearchJob Specialty : Research Studies/ Clin TrialOvertime Status : NONEXEMPTPrimary Shift : DayShift Duration : 8 hourBase Pay : $27.18 - $42.13 Keywords: clinical research, patient recruitment, protocol compliance, data collection, clinical trials, regulatory compliance, informed consent, research coordination, clinical study management, healthcare research