Job Information
ThermoFisher Scientific Neurologist Associate Medical Director - Clinical Research Opportunity!(Onsite Austin, TX) in Austin, Texas
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol, and company processes. Ensures the medical well-being 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:
Carries out clinical evaluation and assessment of participants to ensure eligible participants are enrolled in studies.
Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety, and retention of participants.
Interprets protocols and IB and participates in initiatives to strategize for patient recruitment.
Ensures and protects 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 complies with all medical duties as per protocol, SOP/COP, 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 products (IMP).
Education and Experience:
A valid medical degree (M.D. or D.O.)
A medical license in good standing, with unrestricted ability to practice in place of work, where Applicable. Texas State licensure will be required.
Board Certification in respective field preferred (Neurology).
A valid ICH GCP certificate (this can be obtained upon employment)
No previous experience in clinical research is required but is preferred.
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 confidence in using Microsoft Office and other sponsor-related programs and portals
Good administration skills and a passion for quality and 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 with good prioritization and multitasking skills
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
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.