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Clinical Research Coordinator

4 months ago

Atlanta, United States Thermo Fisher Scientific Full time
Work Schedule
Other

Environmental Conditions
Office

Job Description

Summarized Purpose: Conducts multiple ongoing clinical trials, of varying size and complexity, involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment and retention of study participants. Provides training and guidance to junior team members. Acts as a lead coordinator for certain studies, taking the overall responsibility thereof at the site, liaising with monitors and other stakeholders.

Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

•Provides medical care to patients, always ensuring patient safety comes first. •Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

•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, blood samples, etc.).

•Records all patient information and results from test as per protocol on the 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

•Reviews the overall plan for study conduct for multiple assigned studies and determines how to accomplish. Identifies and communicates any obstacles impeding efficient study conduct.

•Accurately collects and documents data. Ensures correct study documents and computer generated forms are used in compliance with protocol.

•Ensures that timelines are met by working with relevant staff. •Monitors safety and well-being of all study participants through direct and indirect interaction with subjects, and communicates problems to relevant

Qualifications

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification BLS certificate required. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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: •Thorough 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 solve