Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Thermo Fisher Scientific Inc. is committed to improving the world's health, cleanliness, and safety. Join our team in Austin as an Assoc Clinical Research Mgr. You will have a crucial role in advancing clinical trials that have a significant impact on patients' lives.
Job Responsibilities
- Actively participate with senior project team members to meet project needs, projections, and deadlines.
- Coordinate the organization and accuracy of project documents.
- Work with management to understand departmental needs and improve processes effectively.
- Provide support for the study conduct, working directly with study monitors and study subjects.
- Coordinate data entry, source data QC, EDC data entry, EDC query resolution, lab data verification, subject eligibility status review, and subject eligibility notification.
Job Complexity
- Work on problems of limited scope using standard practices and procedures to find solutions.
- Apply company policies and procedures to resolve routine issues confidently.
Qualifications
Education and Experience
- Associate's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience (0 to 2+ years) that provides the knowledge, skills, and abilities to perform the job. Equivalent combinations of education, training, and directly related experience will be considered.
Knowledge, Skills, And Abilities
- Basic knowledge of Phase I processes and clinical study operations.
- Fundamental knowledge of FDA regulations and ICH GCP guidelines.
- Basic computer skills with working knowledge of Microsoft Office applications.
- Strong time management and multi-tasking skills.
- Excellent written and verbal communication skills.
- Ability to prioritize workload and adapt to changing study needs.
- Ability to act as a liaison between external and internal groups.
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.
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 moving) 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 acquire or communicate 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 and multi-task.
- Regular and consistent attendance.
Additional Information
To work at Thermo Fisher Scientific Inc., you need to have been vaccinated against Covid-19 and provide proof upon employment.
