Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
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.
Under the general direction of the Clin Ops Supervisor, the Study Team Associate is responsible for supporting all study management roles within Clinical Operations. This entails tasks within the screening, study conduct and data entry phases of the trials. Inclusive of, but is not limited to, conducting a screening session to provide the Informed Consent session as delegated by the Principal Investigator, overseeing and performing tasks associated with checking in, checking out and conducting outpatient visits for participants actively enrolled in studies as well as performing a variety of team related procedures. Supports team members within their own study team as well as other study teams within the Clinical Operations department.
Essential Functions:
· Fulfills all training expectations associated with tasks that support clinical trials within the study management roles
· Serves as back up, when needed, for study primaries within the Enrollment, Coordinating and Data Entry positions.
· Completes administrative tasks such as preparing, reviewing and verify source as well as overseeing management of supplies for upcoming visits.
Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Previous applicable experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases, a combination of appropriate education, training and/or directly related experience will be considered sufficient and equivalent for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
· Demonstrated ability managing multiple responsibilities and completion of projects with overlapping prioritization.
· Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or data management or electronic source systems.
· Strong communication skills. Ability to clearly explain information to a wide variety of individuals.
· Ability to work closely with multiple types of individuals in potentially difficult or uncomfortable settings.
· Strong attention to detail with strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time.
· Effective time-management while demonstrating ability to communicate need for assistance.
Management Role:
No management responsibility.
Working Conditions and Environment:
· Work is performed in an office or clinical environment.
· Frequent long hours, weekends, and/or holidays.
· Exposure to blood and biohazardous waste.
· Be available by cell phone after hours.
· Potential occasional travel required.
Physical Requirements:
· Frequently vertical and /or 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.
· Frequent 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 moderately complex 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, relates sensitive information to diverse groups.
· Ability to apply basic principles to solve conceptual issues.
· 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.
