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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

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.