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.
• 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 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 is required.
• Occasional crouching, stooping, bending, and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moving) objects including luggage and laptop computers with a maximum lift of 15-20 lbs.
• Ability to access and use various computer software developed 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.

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