06/17/2021
This position is responsible for screening, enrolling, and following study subjects for Phase II, III and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are on study.
Responsibilities:
• Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
• Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff.
• Performs all defined study activities (i.e, informed consent, screening, and protocol procedures which include but not limited to vital signs, blood draws, pregnancy tests, height, weight, ECG's, etc.).
• Schedule subjects for follow up visits and assess subject's response to therapy and evaluate for adverse events.
• Administer study drug therapy as needed and maintain the study drug dispensing.
• Report all serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol. If need be contact subject’s primary care physician.
• Maintenance of accurate and complete documentation including but not limited to regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, drug dispensing logs, subject logs, and study related communications.
• Independently coordinates clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
Qualifications:
• Minimum High School Diploma or GED required.
• Minimum of 1 year of clinical research experience.
• Proficient knowledge of Medical Terminology.
• Strong understanding of FDA clinical trial phases I-IV.
• Proficient computer software and database skills.
• Ability to multi-task and work independently in a fast-paced environment.
