Clinical Research Coordinator 2

The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

DESIRED QUALIFICATIONS:

3+ years of experience working in Sleep Medicine clinical trials. Experience with clinical trial study start-up and close-out activities. Previous experience serving as a study lead for a clinical trial that underwent an FDA audit. Direct participation and experience supporting an FDA audit. Strong knowledge and experience maintaining Investigator Site Files (ISF) and ensuring proper documentation and organization. Strong understanding of clinical trial documentation, regulatory requirements, and study compliance. Knowledge of sleep medicine disorders Experience participating in FDA audits Experience training and supervising a group of at least four Clinical Research Assistants (CRCAs) Experience participating in study start-up and closeout activities Experience recruiting and retaining complex patient populations in clinical trials Experience using Electronic Data Capture (EDC) systems and vendor portals Experience performing ECGs

PHYSICAL REQUIREMENTS*:

Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. #J-18808-Ljbffr Stanford Medicine