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About the Role
The Associate Clinical Research Manager assists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. This role acts as a liaison between senior project team members and study subjects, and involves actively participating and assisting with sponsor, investigator, and research team communications.
Responsibilities
- Actively participate with senior project team members to meet project needs, projections and deadlines.
- Oversee organization and accuracy of project documents.
- Work with management on understanding departmental needs and improving processes.
- Provide support for the study conduct, working directly with study monitor and study subjects.
- Oversee data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.
Requirements
- 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
- Time management and multi-tasking skills
- 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.
- 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.
Skills
- Time management
- Multi-tasking
- Written communication
- Verbal communication
- Prioritization
- Adaptability
- Liaison capabilities
Location
- Office
Work Type
- Standard (Mon-Fri)
Experience Level
- 0 to 2 years
Education Level
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
About the Company
- Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
- Our Mission is to enable our customers to make the world healthier, cleaner and safer.
- Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
- Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Equal Opportunity
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
- Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.