Job Description

Work Schedule

• Standard (Mon-Fri)
• Gen Med Hours: 4 days/week with approx. 3 hours/day
• Some flexibility around days/hours might be able to be accommodated

Environmental Conditions

• Office

Location/Division Specific Information

Trialmed helps biopharmaceutical companies overcome patient enrollment and research site challenges by combining a powerful patient recruiting solution with more than 150 clinical research sites located throughout the world. As a business of PPD, we are committed to optimizing each step in the patient journey and delivering best-in-class site performance to bring our customers greater certainty to clinical trial delivery.

Requirements

• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, which includes a drug screening

About the Role

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.

A Day in the Life

• 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)

Keys to Success

• 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 (can be obtained after employment)
• Exceptional general medical practitioner diagnosis and treatment proficiency
• At least one-year experience working in clinical research, or comparable research/clinical expertise to demonstrate the ability to work in clinical trials
• 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

Physical Requirements and Work Environment

• Frequently stationary for 4-8 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

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.