Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Responsible for management and conduct of clinical studies at our Phoenix, Arizona sites. Ensure compliance, quality, and profitability of clinical studies. Respond to Client issues, concerns, and requests. Responsible for applying study management techniques and tools in order to meet and/or exceed internal and external client needs.
Essential Functions:
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, with flexibility required for business needs
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 and budgeting 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
Celerion Values: Integrity Trust Teamwork Respect
Are you ready to join our team?
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
