Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
Summarized Purpose: Conducts at least one ongoing clinical trial and manages various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between senior project team members and study subjects. Interacts with the research site team and interdepartmental staff to ensure positive interactions with participants at site for study planning, from initiation to closeout.
Essential Functions and Other Job Information:
Actively participates with senior project team members to meet project needs, projections and deadlines.
Oversees organization and accuracy of project documents.
Works with management on understanding departmental needs and improving processes.
Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
Records all patient information and results from tests as per protocol on required forms.
Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
Promotes the company and builds a positive relationship with patients to ensure retention.
Attends site initiation meetings and all other relevant meetings to receive training on protocol.
Required to call patients and follow-up calls as needed to provide information or results.
Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
Gathers source documents and updates as needed, always ensuring relevant and most up to date information is recorded.
Adheres to company COP/SCOP.
May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0
to 2 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 and Abilities:
Basic understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
Demonstrated ability to exercise discretion and sound judgement
Adequate decision-making, negotiation and influencing skills
Decent communication skills and English fluency will be an advantage
Decent organizational skills
Essential proficiency in basic computer applications
Decent interpersonal skills to work in a team environment
Job Complexity:
Works on problems of limited scope.
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Job Knowledge Learns to use professional concepts.
Applies company policies and procedures to resolve routine issues.