Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable.Knowledge, Skills and Abilities:- Basic medical/therapeutic area knowledge and understanding of medical terminology.- Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents.- Good oral and written communication skills, with the ability to communicate effectively with medical personnel.- Good interpersonal skills- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.- Good organizational and time management skills- Ability to remain flexibile and adaptable in a wide range of scenarios.- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.- Ability to manage Risk Based Monitoring concepts and processes.- Ability to work in a team or independently as required.Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.Good English language and grammar skillsManagement Role: No management responsibilityWorking Conditions and Environment:- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.- Frequent drives to site locations. 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.- Personal protective equipment required such as protective eyewear, garments and gloves.- Exposure to fluctuating and/or extreme temperatures on rare occasions.Physical Requirements:- Ability to 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.- Ability to 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.- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.- Regular and consistent attendance.Qualifications:Education and Experience:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.Bachelor's degree preferred.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.
