Work Schedule
Other
Environmental Conditions
Office
Job Description
AES 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 bestinclass 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 SubInvestigator 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 signsoff on regulatory information pertaining to study assignments as applicable to SubInvestigator.
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: Masters Degree in Nursing APRN Prescriptive Authority AANP Board Certified FNP
Experience
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 12 years).
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
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 and prioritize sensitive complex information and problem solve
Advanced analytical ability
Demonstrated ability to exercise discretion and sound judgement
Strong decisionmaking negotiation and influencing skills
Excellent communication skills and English fluency
Excellent organizational skills and detailorientated 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 oncall coverage required.
Physical Requirements:
Frequently stationary for 68 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 1520 lbs.
Ability to access and use a variety of computer software developed both inhouse and offtheshelf.
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 forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Compensation and Benefits
The salary range estimated for this position based in Illinois is $107900.00$215600.00.
This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave 3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short and longterm disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: job posting is for multiple levels:The salary range estimated for the second level is: $$