Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

AES(a division of PPD Clinical Research Services) 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. As part of our continued commitment to the environment, and through our partnership with One Tree Planted, we will plant a tree for every patient enrolled in one of our sites.

Discover Impactful Work:

Serves as Sub-Investigator for particular protocols and supports Principal Investigator in the medical oversight for the study. Provides scientific and medical insight for protocols. Researches compounds being considered by the clinic for subject safety. Evaluates and signs off on medical data collected. Fosters relationships with clients and supports operational and business development staff.

A day in the Life:

• Reviews protocols for scientific, logistical and safety feasibility.
• Conducts specific roles and responsibilities as per the protocol and delegation of authority document and ensures the conduct of the trial is conducted under the requirements relating to obtaining informed consent and IRB approval of the protocol.
• Reviews and signs-off on regulatory information pertaining to study assignments as applicable to Sub-Investigator.
• Researches compounds being considered by the clinic for subject safety.
• Assesses new technology being implemented in the clinic, such as, automated scheduling, electronic informed consents or online Lab and ECG reviews.
• Attends internal meetings related to logistics, training and protocol and client meetings to discuss scientific and medical oversight of a particular protocol or the clinic in general.
• Attends internal/external training related to licensure and medical malpractice requirements and trains staff on new procedures and processes.
• Reviews and consults with clients on new or ongoing projects within the clinic and with the Investigator group on scheduling and study assignments.
• Travels with operational or Business Development staff, attends conferences and prepares and/or reviews posters, scientific papers and publications related to protocols conducted in the Early Phase Clinical Research Unit

Keys to Success:

Education

• Master's Degree in Nursing or Master's Degree Physician Assistant
• APRN Prescriptive Authority
• Board Certified in respecitive field

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job. Candidates with clinical research or sub-Investigator experience are preferred.

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, Abilities

• Knowledge of important regulatory considerations
• Proven ability to assess the safety and tolerability of different classes of drugs
• Knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
• Demonstrated ability to work independently, analyze and work with attention to detail, process andprioritize sensitive complex information and problem solve
• Advanced analytical ability
• Demonstrated ability to exercise discretion and sound judgement
• Strong decision-making, negotiation and influencing skills
• Excellent communication skills and English fluency
• Excellent organizational skills and detail-orientated leadership approach
• Flexibility to travel domestically and internationally
• Proficiency in basic computer applications
• Strong ability to work in a team environment

Physical Requirements / Work 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.
• Occasional on-call coverage required.

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.
• Regular and consistent attendance

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!