• Conducts clinical studies according to FDA/GCP and ICH regulations and
• Provides medical care to patients, always ensuring patient safety comes first.
• Performs all defined study activities (i.e, informed consent, screening, and
protocol procedures which include but not limited to vital signs, pregnancy tests,
height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB
requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure
• Attends site initiation meetings and all other relevant meetings to receive
training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to
confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information
provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is
completed within timeframe.
• Gathers source documents, updates patient files and notes, always ensuring
relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in
keeping a general neat appearance of the facility.
Job Complexity Works on problems of limited scope. Follows standard practices and procedures in
analysing situations or data from which answers can be readily obtained.
Job Knowledge Learns to use professional concepts. Applies company policies and procedures to
resolve routine issues.
Normally receives detailed instructions on all work.
Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"),
collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.
Contacts are primarily with immediate supervisor, and other personnel in the
department. Builds stable working relationships internally.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical /
Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with
local health care authority.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0
to 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.
Vaccination preparation and administration experience highly desired.
Knowledge, Skills and Abilities:
• Basic understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety
• Capable of working independently, analyzing and working with attention to detail, processing and
prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Adequate decision-making, negotiation and influencing skills
• Decent communication skills and English fluency will be an advantage
• Decent organizational skills
• Essential proficiency in basic computer applications
• Decent interpersonal skills to work in a team environment
No management responsibility
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Occasional travel, may be domestic or international.
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 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.