Qualifications:

Education and Experience:

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
• Technical positions may require a certificate.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• 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:

• Good understanding of Good Clinical Practices (GCP), with the ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs.
• Solid organizational skills and flexibility to manage workload and meet changing timelines.
• Firm attention to detail to ensure accuracy and efficiency in data entry.
• Solid interpersonal/customer service skills, positive attitude, and good oral and written communication.
• Capable of working in a team or independently.
• Solid English language and grammar skills.
• Good computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint) and a basic understanding of clinical trial database systems.
• Good analytical and data management skills to effectively analyze data/systems to ensure accuracy and efficiency.
• BLS or CPR certification.
• Ability to multi-task and have oversight over a few studies with a number of participants simultaneously.
• Strong attention to detail.
• Working knowledge of medical terminology is an advantage.

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential occasional travel required.

Physical Requirements:

• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending, and twisting of the 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 information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• 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.