Salary Range: $36.65 - $56.67/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. The CRC-II works closely with study physicians, stakeholders, and sponsors, providing study management, support, and coordination for FDA-regulated, industry-sponsored, government-funded, and investigator-initiated clinical trials. This includes blood collection and managing studies with therapeutic or device components. The CRC-II ensures smooth and accurate processes from study planning to post-study closure. The CRC-II is involved in protocol review, informed consent, development of treatment plans, completion of study forms, and ensuring protocol assessments are completed as per guidelines. Responsibilities also include processing lab samples, maintaining communication with sponsors, ensuring accurate CRF completion, adverse event reporting, and subject follow-up visits. The CRC-II discusses studies with potential subjects, obtains informed consent, develops study documentation, assesses eligibility, and manages data collection and entry. The role involves hosting team meetings, attending site visits, and other duties as assigned. The ideal candidate must be knowledgeable of Good Clinical Practices, human subject protection, and FDA regulations regarding clinical research. Education and Experience: High School Diploma with 2-3 years of Clinical Research Coordinator experience or equivalent. Excellent communication, organizational, and interpersonal skills. Attention to detail and proficiency with Microsoft Office. Strong analytical and problem-solving skills. Ability to work effectively in a fast-paced, team environment, prioritize tasks, and meet deadlines. Ability to establish cooperative relationships with patients, colleagues, and physicians. Preferred Qualifications: Medical terminology knowledge; familiarity with FDA, NIH, OHRP regulations, and ICH GCP guidelines. Experience with clinical trial methodologies and IRB documentation. Ability to abstract data from medical records into databases. IATA Certification. Current ACRP or SoCRA Certification. Hoag is an Equal Opportunity Employer, committed to a work environment free of discrimination and harassment, and embraces diversity to help employees reach their full potential. #J-18808-Ljbffr Hoag
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