Job Description

　　Summarized Purpose:

　　Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Maintains clinical oversight and quality on the studies registered on and delivers on study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants.

　　Essential Functions and Other Job Information:

　　Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled onto studies.

　　Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.

　　Interprets protocols and IB and participate in initiatives to strategize for patient recruitment.

　　Ensures and protect the welfare and safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.

　　Fulfills and comply with all medical duties as per protocol, SOP/COP and ICH GCP and local regulations.

　　Reports any safety threats, that may impact stakeholders/participants and action complaints or QIs as per site processes.

　　Exercises meticulous attention to detail in recording information and source management.

　　Actively involved in audit preparations and site inspections.

　　Oversees the management of investigational medical product (IMP).

　　Job Complexity : Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

　　Job Knowledge: A seasoned, experienced professional with a full understanding of area of specialization resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

　　Supervision Received: Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

　　Business Relationships: Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

　　Qualifications:

　　Education and Experience: A valid medical degree and registration within the country of practice

　　A medical license in good standing, with unrestricted ability to practice in place of work, where applicable

　　A valid ICH GCP certificate

　　No previous experience in clinical research years of required, but must have general medical practitioner diagnosis and treatment proficiency

　　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:

　　Good understanding of medical terminology, drug safety, and interpretation of lab reports

　　Computer proficiency and confident in using Microsoft Office and other sponsor related programs and portals

　　Good administration skills and a passion for quality and detail

　　Comprehensive attention to detail

　　Capable of working well under pressure and meeting deadlines

　　Good understanding of commercial and financial concepts and the impact thereof on the business

　　Capable of consistently working well with others and assisting in other areas as needed

　　Capable of learning new processes and systems quickly

　　Strong cognitive skills, with the ability to think, read, learn, reason, interpret and pay attention to detail in daily operations and tasks

　　Capable of working independently

　　Good prioritization and multitasking skills

　　Management Role: No management responsibility

　　Working Conditions and Environment:

　　Work is performed in an office environment with exposure to electrical office equipment.

　　Occasional travel locally and internationally

　　Physical Requirements:

　　Frequently stationary 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, 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.

　　Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

　　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.

　　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.