Clinical Research Coordinator-RN II

Job Title: Clinical Research Coordinator-RN II
Duties: Job Summary:The Clinical Research Coordinator-Registered Nurse II (CRC RN-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians inter- and intradepartmental stakeholders and position is responsible for managing complex clinical research trials including drug device and biologic studies across Phase I II III and IV clinical trials government-funded research and investigator-initiated studies while ensuring compliance with Good Clinical Practice standards human subject protection regulations and FDA guidelines.
Job Responsibilities:-Manages complex clinical research trials including industry-sponsored government-funded and investigator-initiated studies.-Maintains compliance with Good Clinical Practices FDA regulations and human subject protection standards.-Provides overall study management coordination and operational support for assigned research trials.-Performs protocol review and preparation activities prior to study initiation.-Administers and manages the informed consent process in accordance with regulatory requirements.-Conducts subject recruitment screening and eligibility assessments based on inclusion and exclusion criteria.-Collects processes and documents laboratory samples in compliance with International Air Transport Association standards.-Ensures completion of all protocol-required clinical assessments and procedures.-Accurately collects records and enters study data into clinical research databases while maintaining data integrity and quality.-Completes case report forms and addresses data queries in a timely manner.-Monitors and reports adverse events according to protocol and regulatory requirements.-Maintains regulatory binders and study documentation in accordance with sponsor and regulatory standards.-Develops study flow sheets and prepares study source documentation.-Hosts and participates in study team meetings and site initiation visits.-Assists with cost analysis study budget preparation and tracking and distribution of study funds.-Supports the growth and strategic vision of the Hoag Institute for Research and Education.-Assists with training and mentoring other Clinical Research Coordinators as needed.-Promotes team building and fosters a positive and respectful work environment.-Performs other duties as assigned.
Skills: Required Skills & Experience:-Two (2) or more years of experience performing clinical research duties or equivalent experience and training.-Knowledge of Good Clinical Practices protection of human subjects and FDA regulatory guidelines.-Excellent verbal and written communication skills.-Strong organizational skills with close attention to detail.-Excellent interpersonal skills to work effectively within a diverse team environment.-Strong analytical and problem-solving skills.-Proficiency in Microsoft Word PowerPoint and Windows-based applications.-Ability to work effectively in a fast-paced team-based environment.-Project management and coordination skills with the ability to prioritize tasks and meet multiple deadlines.-Ability to establish and maintain cooperative working relationships with patients physicians and coworkers.-Ability to behave professionally in all work settings and promote team-building behaviors.-Ability to follow organizational and departmental policies and procedures.-Ability to travel locally between organization locations as required.
Preferred Skills & Experience:-Working knowledge of FDA NIH and OHRP regulatory requirements.-Working knowledge of ICH Good Clinical Practice guidelines.-Understanding of clinical trial methodologies.-Experience filing Institutional Review Board documentation.-Ability to abstract data from medical records and transfer information into data collection forms or electronic databases.
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Education: Required Education:-High School Diploma.
Preferred Education:-Bachelor of Science in Nursing (BSN) Degree or higher.
Required Certifications & Licensure:-Current licensure in good standing as a Registered Nurse in the State of California.-Basic Life Support (BLS) Certification.
Preferred Certifications & Licensure:-Current ACRP -SoCRA Certification.-Nursing Specialty Certification.-International Air Transport Association (IATA) Certification