ThermoFisher Scientific
Sr Clinical Research Associate (CRA)/Principal CRA - West
ThermoFisher Scientific, Cheyenne, Wyoming, United States, 82007
ThermoFisher Scientific Sr Clinical Research Associate (CRA)/Principal CRA - West Cheyenne, Wyoming
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.This position requires overnight travel either regionally or nationally, dependent on business needs.Discover Impactful Work:Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.A Day in the Life:Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Keys to Success:Education:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). Valid driver's license where applicable.Knowledge, Skills and Abilities:Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manage Risk Based Monitoring concepts and processesEffective oral and written communication skillsStrong attention to detailEffective organizational and time management skillsAbility to work in a team or independently as requiredGood computer skills: proficient knowledge of Microsoft OfficeThermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Compensation and Benefits:The salary range estimated for this position based in California is $90,000.00–$157,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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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.This position requires overnight travel either regionally or nationally, dependent on business needs.Discover Impactful Work:Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.A Day in the Life:Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Keys to Success:Education:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). Valid driver's license where applicable.Knowledge, Skills and Abilities:Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manage Risk Based Monitoring concepts and processesEffective oral and written communication skillsStrong attention to detailEffective organizational and time management skillsAbility to work in a team or independently as requiredGood computer skills: proficient knowledge of Microsoft OfficeThermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Compensation and Benefits:The salary range estimated for this position based in California is $90,000.00–$157,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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