The focus of the post doctoral associate will be research studies in the field of anesthesiology, with a focus on but not limited to measurement of quality of care, quality assurance and quality improvement activities, acute and chronic pain, anesthesia outcomes, malignant hyperthermia, pharmacology of anesthetic drugs, and regional anesthesia techniques.
Under the supervision of the PI, this individual is responsible for coordination of clinical research studies. This individual will need to be able to prioritize tasks related to several research studies at a time, and to work with multiple primary investigators. This individual will be responsible for developing the infrastructure necessary for a successful clinical research program and building the research program over time. He or she will need to be familiar with and apply Knowledge of Good Clinical Practices and the Code of Federal Regulations to ensure compliance with best practices and regulations. This position requires excellent interpersonal and communication skills, attention to detail and organizational skills. This position requires the ability to handle multiple projects and priorities to provide safe, quality care to research participants.
Subject and Data Management (60%) • Act as resource for protocol development, statistical design and budget preparation • Translate protocol required activities into flow sheets and patient care orders • Serve as liaison with clinics and offices to facilitate recruitment • Organize and implement subject identification, recruitment, enrollment, and retention, including follow-up calls • Obtain data and accurately transit to appropriate database • Maintain source documents • Organize, prioritize, and accomplish daily tasks related to anesthesiology protocols • Identify and assess adverse events; responsible for subject protocol triage and symptom management; report adverse events in a timely fashion • Assist in analysis of results; assist with development and submission of abstracts and publications
Regulatory Management (20%) • Manage all aspects of human subject protection regulations: complete required IRB regulatory documentation, manage all IRB submissions and correspondence in conjunction with PI • Track and maintain all binders and regulatory documents • Prepare for and participate in site initiation visits, monitoring visits, regulatory audits, etc.
Administration (20%) • Develop and maintain departmental research database; obtain and publish updates of study progress • Serve and a member of the Anesthesiology Research Committee • Coordinate site visits, audits • Work to identify potential industry study protocols
Ph.D., MD or equivalent
Experience and proficiency with protocol development, including basic statistical concepts (sample size calculation, alpha and beta error, etc)
Experience with paper and computerized clinical case report forms and data collection; experience with research databases and study spread sheets
Knowledge of Good Clinical Practices and federal regulations related to clinical research, including knowledge of adverse event reporting
Computer proficiency and ability to navigate multiple software applications; experience with EPIC or similar electronic medical record systems, ability to extract relevant data from medical records
Ability to work flexible hours as required to recruit and enroll research subjects
Ability to organize and manage several protocols concurrently; ability to prioritize tasks; meticulous attention to detail
Experience developing study databases such as Access or similar
?Ability to work independently, make decisions, problem solve and prioritize the simultaneous management multiple clinical studies.
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