NCIRE researchers in collaboration with UCSF faculty are seeking a full-time Clinical Trial Manager to provide day-to-day management including trial start-up, conduct, and closeout activities for a sponsor-investigator initiated research study examining the neurocognitive performance effects of a Phase III hypnotic medication.
The Trial Manager will be responsible for the development and management of the clinical research protocol, including monitoring the study progress to ensure adherence to timelines, SOPs, protocol and applicable regulations. The individual will work closely with their study team such as the subject recruiter, database manager, neuropsychologist, Clinical Research Center, biostatistician and clinical research associates to implement practical procedures strategies to ensure precise adherence to the goals of the study. The successful candidate will also be responsible for all the regulatory aspects of the trial, submission of the sponsor-investigator IND, establishing a monitoring plan, safety tracking and reporting, as well as coordinating timelines, budgets and study relevant procedures. .
The ideal candidate will have:
• Minimum of 7 years industry experience, with at least 3 years in direct clinical trial management
• MA/MS degree in psychology or related fields preferred
• Has a thorough understanding of FDA, ICH, and GCP regulations, guidelines, policies and practices for conducting clinical investigations
• Computer literacy with emphasis on Windows operating systems and software applications
• Excellent interpersonal, written/oral communication and organizational skills
• Ability to manage multiple projects, tasks and priorities to achieve desired goals
• Strong accuracy and attention to detail
• Ability to work under minimal supervision
Please apply online by visiting: www.ncire.org and apply to job# 2009-1425 found on “Careers at NCIRE”.
NCIRE offers a competitive compensation and generous benefits package, a stable, exciting environment and a wonderful work/life balance. NCIRE conducts research in many fields, including mental health, neurological disease, cardiovascular disease, cancer, bone disease, infectious diseases including HIV, and improving patient care.
For more information about NCIRE please visit us at www.ncire.org.
NCIRE is an Equal Opportunity Employer
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PostingID: 1454757241