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.
Within Medical Communications, we improve patient health by supplying medical information services to our customers, patients and healthcare providers. We engage with healthcare professionals, regulatory agencies and pharmaceutical customers to help them navigate regulatory and compliance requirements around the world. We manage medical information inquiries, document adverse events and product complaints, report product launches, prepare standard responses to inquiries and develop process improvements for customer implementation.
Discover Impactful Work: Provides technical and medical information, and/or performs intake of adverse events/ product complaints with quality customer service. Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. The information provided will be given to a level in parallel with the individual's expertise, experience and training.
Working under the direction of the chief physician/investigator and the Staff Paramedic in the Clinic, ensures subject safety, health and well-being. Continually monitors the subject population at all times,
noting and treating Adverse Events (AEs) as needed. Acts as the primary assistant to the
Paramedic Manager in observing, documenting, and treating AEs, or directly deferring to the physician/investigator as needed.
Essential Functions and Other Job Information: Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. • Provides medical care to patients, always ensuring patient safety comes first. • Performs all defined study activities (i.e, informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). • Records all patient information and results from tests as per protocol on required forms. • Where required, may complete IP accountability logs and associated information. • Reports suspected non-compliance to relevant site staff. • 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. • May be required to call patients, do patient bookings and follow-up calls to confirm bookings or 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, updates patient files and notes, 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 in the clinical /
medical field
BLS certificate required.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0
to 2 years').
Job Tags
Full time, Work at office,