Thermo Fisher Scientific
Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) - Centra
Thermo Fisher Scientific, Chicago, Illinois, United States, 60290
Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) - Central and West Coast
At Thermo Fisher Scientific, you will work on clinical trials conducted in 100+ countries and contribute to our mission of enabling customers to make the world healthier, cleaner and safer. This role supports end-to-end clinical operations from study start-up to monitoring and close-out, across commercial and government contracts, with a focus on renal/transplant/nephrology therapeutic areas. Work Schedule Standard (Mon-Fri) Environment Office Overview
Our global Clinical Operations team within PPD clinical research services provides end-to-end support for clinical trials and helps clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient studies. You will perform and coordinate all aspects of the clinical monitoring and site management process, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. We are hiring for CRA (Level II), Sr CRA (Level I), Sr CRA (Level II), and Principal CRA openings. Responsibilities
Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis, critical thinking and problem-solving to identify site process failures and implement corrective/preventive actions to bring the site into compliance and reduce risk. Ensures data accuracy through SDR, SDV and CRF review during on-site and remote monitoring activities. Assesses investigational products through physical inventory and records review; documents observations in reports and letters using approved business writing standards. Escalates deficiencies to clinical management and sees issues through resolution. Maintains regular contact with sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording. Conducts monitoring tasks per the monitoring plan and participates in the investigator payment process. Collaborates with project team members to resolve issues/findings; investigates and follows up as applicable. Participates in investigator meetings; identifies potential investigators to ensure qualified sites. Initiates clinical trial sites per procedures to ensure compliance with protocol, regulatory, and ICH-GCP obligations; makes recommendations when warranted. Performs trial close-out and retrieval of trial materials; ensures essential documents are complete per ICH-GCP and regulations. Conducts on-site file reviews per project specifications; provides trial status tracking and progress updates to the Clinical Team Manager (CTM). Ensures study systems are updated per study conventions (e.g., CTMS); facilitates effective communication among sites, sponsor, and project team. Responds to sponsor/client/regulatory requirements, audits, and inspections; maintains administrative tasks such as expense reports and timesheets. Contributes to project publications/tools and process improvements; supports team with ideas and suggestions. Progressive responsibilities may be expected with increasing CRA level. Qualifications
Bachelor's degree in a life science field or RN certification or equivalent; relevant qualifications as required. Therapeutic experience in renal, transplant, and/or nephrology. CRA Level II: 1+ year of clinical research monitoring experience; Sr CRA Level I: 2+ years; Sr CRA Level II: 3+ years; Principal CRA: 5+ years with broad monitoring expertise. Valid driver’s license where applicable. Proven clinical monitoring skills with working knowledge of ICH-GCP, regulations, and procedures. Knowledge, Skills, Abilities
Strong data management and clinical monitoring capabilities; ability to apply risk-based monitoring concepts. Excellent written and verbal communication; ability to interact effectively with medical personnel and sponsors. Strong organizational, time management, and teamwork skills; attention to detail; adaptability. Proficiency with Microsoft Office; ability to learn clinical trial systems. English language proficiency and presentation skills. Requirements
Willingness to travel frequently (approximately 60-80%), with possible overnight stays. Ability to work in diverse environments and to meet sponsor/site requirements, including vaccination status disclosures where applicable. Benefits and Compensation
Salary range for this position in California: $82,800.00 - $140,000.00, with potential eligibility for an annual bonus. We offer a comprehensive total rewards package including medical/dental/vision plans, employee assistance and family support programs, PTO, holidays, parental leave, retirement savings plans, and stock purchase plan. This posting covers multiple CRA levels with corresponding salary ranges. 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 will work on clinical trials conducted in 100+ countries and contribute to our mission of enabling customers to make the world healthier, cleaner and safer. This role supports end-to-end clinical operations from study start-up to monitoring and close-out, across commercial and government contracts, with a focus on renal/transplant/nephrology therapeutic areas. Work Schedule Standard (Mon-Fri) Environment Office Overview
Our global Clinical Operations team within PPD clinical research services provides end-to-end support for clinical trials and helps clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient studies. You will perform and coordinate all aspects of the clinical monitoring and site management process, including remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. We are hiring for CRA (Level II), Sr CRA (Level I), Sr CRA (Level II), and Principal CRA openings. Responsibilities
Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis, critical thinking and problem-solving to identify site process failures and implement corrective/preventive actions to bring the site into compliance and reduce risk. Ensures data accuracy through SDR, SDV and CRF review during on-site and remote monitoring activities. Assesses investigational products through physical inventory and records review; documents observations in reports and letters using approved business writing standards. Escalates deficiencies to clinical management and sees issues through resolution. Maintains regular contact with sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording. Conducts monitoring tasks per the monitoring plan and participates in the investigator payment process. Collaborates with project team members to resolve issues/findings; investigates and follows up as applicable. Participates in investigator meetings; identifies potential investigators to ensure qualified sites. Initiates clinical trial sites per procedures to ensure compliance with protocol, regulatory, and ICH-GCP obligations; makes recommendations when warranted. Performs trial close-out and retrieval of trial materials; ensures essential documents are complete per ICH-GCP and regulations. Conducts on-site file reviews per project specifications; provides trial status tracking and progress updates to the Clinical Team Manager (CTM). Ensures study systems are updated per study conventions (e.g., CTMS); facilitates effective communication among sites, sponsor, and project team. Responds to sponsor/client/regulatory requirements, audits, and inspections; maintains administrative tasks such as expense reports and timesheets. Contributes to project publications/tools and process improvements; supports team with ideas and suggestions. Progressive responsibilities may be expected with increasing CRA level. Qualifications
Bachelor's degree in a life science field or RN certification or equivalent; relevant qualifications as required. Therapeutic experience in renal, transplant, and/or nephrology. CRA Level II: 1+ year of clinical research monitoring experience; Sr CRA Level I: 2+ years; Sr CRA Level II: 3+ years; Principal CRA: 5+ years with broad monitoring expertise. Valid driver’s license where applicable. Proven clinical monitoring skills with working knowledge of ICH-GCP, regulations, and procedures. Knowledge, Skills, Abilities
Strong data management and clinical monitoring capabilities; ability to apply risk-based monitoring concepts. Excellent written and verbal communication; ability to interact effectively with medical personnel and sponsors. Strong organizational, time management, and teamwork skills; attention to detail; adaptability. Proficiency with Microsoft Office; ability to learn clinical trial systems. English language proficiency and presentation skills. Requirements
Willingness to travel frequently (approximately 60-80%), with possible overnight stays. Ability to work in diverse environments and to meet sponsor/site requirements, including vaccination status disclosures where applicable. Benefits and Compensation
Salary range for this position in California: $82,800.00 - $140,000.00, with potential eligibility for an annual bonus. We offer a comprehensive total rewards package including medical/dental/vision plans, employee assistance and family support programs, PTO, holidays, parental leave, retirement savings plans, and stock purchase plan. This posting covers multiple CRA levels with corresponding salary ranges. 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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