Job description

Duties: Responsible for creating work flow procedures and leading the operations for the Data Coordinating Center (DCC) for a multi-site observational clinical trial within the Department of Medicine. Candidate will manage the regulatory compliance of all sites relying on Penn's IRB as the Central IRB and oversee regulatory compliance of sites operating under their own institution's IRB. Candidate will prepare, revise, and submit protocols; prepare and maintain study documents and supplies; manage protocol execution at allied sites; collect, prepare and process specimens shipped to Penn; manage periodic shipping of biologic samples to study Sponsors and Investigators; observe and report adverse events; develop and maintain patient database; lead project development; oversee data entry and management of study subject databases; draft or type correspondence; coordinate accrual of subjects for all sites in the study; develop and maintain tracking databases of study subjects and participation for all sites; and perform study related duties as assigned.

Qualifications: BA/BS degree in scientific-related field and 3-5 years of experience, or equivalent combination of education and experience, are required. Advanced project management experience preferred; must have excellent computer skills, excellent organizational skills and attention to detail. Individual must work independently and be self-directed. Strong IRB and regulatory experience preferred. Experience with REDcap desirable. Knowledge of Microsoft Excel & Word required. Excellent verbal and written communication skills required.

Reference Number: 40-25990

Salary Grade: 027

Employment Type: Exempt

Org: DM-Renal-Electrolyte and Hypertension

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: I-Technical/Professional Research




Diversity Profile: University



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Job No:
Posted: 5/26/2017
Application Due: 5/26/2018
Work Type: