Neurologist Associate Medical Director - Clinical Research Opportunity!(Onsite Austin, TX)

Work Schedule

Environmental Conditions

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