CLINICAL RESEARCH COORDINATOR II - CLINICAL RESEARCH CANCER (Newport Beach, CA, US, 92617) - Hoag

Salary Range: $35.5900 - $54.7500 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.

Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.

• The CRC-II provides study management, support, and coordination for FDA-regulated research industry-sponsored, government-funded, and/or investigator initiated clinical research trials.
• This may include blood collection, data, and trials that have therapeutic or device components.  
• The CRC-II ensures the smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures.
• The CRC-II is involved in all aspects of the clinical research process, but not limited to protocol review, preparation, and administration of the informed consent, development of study treatment plans, completion of study-related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, and regular communication with study sponsors and their collaborators.
• Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent.
• Responsible for the development of study flow sheets, preparing study source documentation, gathering study data, and assessing subjects for study eligibility (inclusion/exclusion). In addition, the CRC-II will record protocol-specific assessments and treatments, ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, and collect, enter, and clean data into the study database while maintaining data quality. I. He/she will host study team meetings, attend site initiation visits (SIVs), and perform other duties as assigned.

Education and Experience

• High School Diploma with 2-3 years of Clinical Research Coordinator experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Excellent verbal and written communication and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Attention to detail.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.

PREFERRED QUALIFICATIONS

• 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.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• International Air Transport Association (IATA) Certification
• Current ACRP or SoCRA Certification.

• Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.

Certifications Preferred

• May only perform blood draws by meeting and maintaining State of California Certified Phlebotomy Technician I (CPTI) Certification

Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.