Thermo Fisher / PPD
Work Schedule
Other
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
Conducts multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process.
Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrolment and retention of study participants. Provides training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders
Flexible day hours working maximum 20 hours per week. Both day and night shifts (or both) are available!
Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines
Provides medical care to patients, always ensuring patient safety comes first
Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized
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, blood samples, etc.)
Records all patient information and results from test as per protocol on the required forms
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 retention
Attends site initiation meetings and all other relevant meetings to receive training on protocol
Reviews the overall plan for study conduct for multiple assigned studies and determines how to accomplish
Identifies and communicates any obstacles impeding efficient study conduct
Accurately collects and documents data. Ensures correct study documents and computer generated forms are used in compliance with protocol.
Ensures that timelines are met by working with relevant staff.
Monitors safety and well-being of all study participants through direct and indirect interaction with subjects, and communicates problems to relevant stakeholders
Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure
Serves as a primary point of sponsor contact for all research activities for studies assigned
Ensures all communications are documented and shared with the appropriate team members
Acts as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time.
Involved in the interview and hiring process of new team members. Assists in the training of new team members and provides mentoring. Provides input into evaluations performance reviews of team members . Performs other study related duties as qualified by documented training
Education and Experience:
Czech Language is essential (minimum A2 level)
Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical /
medical field
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 5+ 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.
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.
Knowledge, Skills and Abilities:
Thorough understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
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
Solid decision-making, negotiation and influencing skills
• Strong communication skills and English fluency will be an advantage
Strong organizational skills
Strong proficiency in basic computer applications
Solid interpersonal skills to work in a team environment
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.