05/14/2019
Overview:
Researchers from the San Francisco VA Medical Center and Northern California Institute for Research and Education (NCIRE) are conducting an investigator-initiated multi-site research study to test a medication for the treatment of insomnia in Veterans with Posttraumatic Stress Disorder (PTSD). The incumbent will serve as the Clinical Trial Coordinator for the project and will provide day-to-day management including trial start-up, conduct, and closeout activities, and coordination with the other study site. Opportunities to assist with data analysis, manuscripts. The lab is seeking at least a 2-year commitment for this position.
Responsibilities:
• Coordinate all aspects of the research protocol & manage the daily study operations
• Develop and manage clinical study protocol, Informed Consent Form, Case Report Forms and Standard Operating Procedures
• Develop and oversee systems for tracking / monitoring study progress to ensure adherence to timelines, SOPs, and applicable regulations
• Maintain essential research study documentation
• Conduct telephone screening interviews on psychiatric and medical symptomatology with participants to pre-assess for study eligibility
• Work closely with study recruiters to ensure adherence to the enrollment goals of the study
• Provide and document Informed Consent of participants
• Schedule all assessment study visits and study procedures
• Administer experimental psychophysiology testing
• Coordinate with the multidisciplinary study team (e.g., clinical interviewer, nurse practitioners, research assistants, clinical laboratory) in determining study eligibility, coordinating study procedures, and ensuring adherence to study protocol
• Coordinate all aspects of data management, including entry, verification and analysis
• Maintain rapport with each participant and assist with all study procedures
• Plan and track budget; purchase equipment and supplies, and track study expenditures
• Manage shipment of biological samples to offsite laboratory, sample tracking, correspondence with laboratories
• Work closely with data management team to ensure study data is shared among study sites
• Assist in hiring and training the study staff research associates and psychological technicians
• Perform other duties as assigned
Qualifications:
• Minimum of 2 years clinical trial management experience preferred
• Bachelor’s degree in psychology, nursing or related field required
• MA/MS degree in psychology, nursing or related fields preferred
• 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
• Prior experience in psychophysiology measurement experience using Biopac or similar equipment is preferred
• Prior experience with experimental software applications (e.g., AcqKnowledge, Inquisit, SuperLab, Qualtrics) is preferred
• Prior experience collecting, organizing, and shipping biological samples is preferred.
• Excellent interpersonal, written/oral communication and organizational skills
• Ability to manage research staff, as well as multiple projects, tasks and priorities to achieve desired goals
• Strong accuracy and attention to detail
• Ability to work under minimal supervision
Supervision Received: PI: Dr. Sabra Inslicht at the San Francisco VA Health Care System/UCSF; collaboration with the Stress and Health Research Program at the SFVAHCS
Supervision Exercised: Supervision of research assistants
Background Check: As a federal employee the following background checks are required: License and educational verification, prior employment verification, s*x offender registry check, criminal history, US citizenship verification, and fingerprinting.
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