Essential Functions

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Management of Clinical Studies
• On-time performance with defect-free execution
• Independently conduct simple studies such as bioequivalency and bioavailability studies
• With supervision, may assist on complex studies
• Work with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics)
• Set up study initiation meetings to plan execution of study
• Conduct study review meetings for pre-study, in-process and post study review
• Problem solve as needed during study conduct
• Meet with clients as needed throughout study
• Organize study logistics and personnel
• Be present at critical events and dosings of study
• Builds client relationships that result in additional business
• Create and edit reports
• Respond to client issues, concerns and requests
• Adhere to milestone guidelines


Ensure profitability
• Maintain profitability of team through a budgeting and expense control on a total and individual study basis
• Coordinate with Purchasing to ensure expense control


Study Preparation
• Interpret and implement study specification sheet
• Supervise associates during study conduct
• Assign duties to clinic staff
• Assess and take action as special situations occur in study conduct
• Ensure timely and accurate data is collected


Ensure compliance and quality
• Ensure compliance with client protocol, Standard Operating Procedures and federal regulations
• Respond to Quality Assurance audits in timely manner
• Respond to data management edit checks


May be responsible for staff management in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees 


Schedule: Monday - Friday 8 AM - 5 PM, flexibility required w/ some remote capability

Knowledge/ Skills/ Education/ Licenses

• Bachelor’s degree in a related field or BSN required.
• Industry experience preferred.
• Proven organization skills
• Ability to manage multiple priorities
• Excellent oral and written communication skills
• Knowledge of medical terminology preferred
• Ability to work without close supervision
• Ability to work hours required for study conduct
• Strong customer service skills
• Planning and scheduling skills
• Proven multi-tasking skills