Education and Experience:

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Effective clinical monitoring skills
• Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Leads Risk Based Monitoring concepts and processes
• Mentor and train other monitors in a positive and effective manner
• Evaluate medical research data and proficient knowledge of medical terminology
• Effective verbal and written communication skills, with the ability to connect with medical personnel
• Ability to maintain customer focus through the utilization of listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Can work independently and apply problem-solving techniques applicable to constantly evolving environment
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.

Physical Requirements:

• Work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.