Work Schedule
First Shift (Days)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between the Sponsor, the Investigator and the research team. Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the client for resolution.
Essential Functions and Other Job Information:
• Serves as a primary point of contact for sponsors and the business unit for
clinical site related aspects of the study.
• Collaborates with internal departments to ensure deliverables are met as defined
within the contract and study timeline.
• Manages all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction, and data collection.
• Manages IRB submissions. including creation of study specific informed consent
forms, SAE notifications, and maintenance of the regulatory file and documents.
• Collects feedback from various departments to create a risk register for each
study, and maintains and updates the register throughout the study; works with
the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized
and reviewed by the safety committee prior to study conduct.
• Works closely with finance department to manage fiscal aspects of study conduct
while meeting sponsor requirements and adhering to the protocol, SOPs, and
contract.
• Provides vendor oversight when services are contracted.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 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.
Knowledge, Skills and Abilities:
• Knowledge of Phase I processes and strong knowledge of clinical study operations
• Knowledge of FDA regulations and ICH GCP guidelines
• Knowledge of budgeting/forecasting/planning projects
• Solid computer skills with working knowledge of Microsoft Office applications
• Good time management and multi-tasking skills
• Excellent written and verbal communication skills
• Demonstrated ability to prioritize workload and adapt to changing study needs
• Demonstrated ability to act as a liaison between external and internal groups
Management Role:
No management responsibility
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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