Thermo Fisher Scientific
Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) - Centra
Thermo Fisher Scientific, Carlsbad, California, United States, 92002
Overview
Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) – Central and West Coast. The role supports end-to-end clinical trial activities within Thermo Fisher Scientific’s clinical research services portfolio, contributing to study start-up, monitoring, data quality, and study close-out across commercial and government contracts. Responsibilities
Monitor investigator sites with a risk-based approach; apply root cause analysis, critical thinking and problem solving to identify site processes failures and implement corrective/preventive actions to ensure compliance and reduce risk. Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring activities. Assess investigational products through physical inventory and records review; document observations promptly using approved business writing standards. Escalate deficiencies and issues to clinical management and follow through to resolution. Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording between visits. Conduct monitoring tasks per the monitoring plan and participate in the investigator payment process. Collaborate with project team members on issue resolution and follow-up on findings. Participate in investigator meetings and assist in identifying qualified investigators in collaboration with the client company. Initiate clinical trial sites per procedures to ensure compliance with protocol, regulatory and ICH-GCP obligations; make recommendations as warranted. Perform trial close-out and retrieval of trial materials; ensure essential documents are complete and filed per ICH-GCP and regulations. Conduct on-site file reviews as required; provide status updates to the Clinical Team Manager and ensure study systems are updated per study conventions (e.g., CTMS). Facilitate communication between investigative sites, client company and project team; respond to sponsor/client/site audits/inspections. Complete administrative tasks (expense reports, timesheets) in a timely manner; contribute to project publications/tools and process improvement initiatives. Progressively take on increased responsibilities corresponding to CRA level expectations. Qualifications
Bachelor’s degree in life sciences or nursing certification or equivalent; relevant vocational qualification. 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: extensive monitoring experience with broad expertise. Valid driver’s license where applicable. Proven clinical monitoring skills and working knowledge of ICH-GCP and applicable regulations. Strong written and verbal communication, critical thinking, risk-based monitoring knowledge, and ability to work independently or in a team. Work Environment & Requirements
Standard office environment with potential travel; frequent site visits and travel typical to role (approximately 60–80%, with variations). Ability to work in diverse environments; predictability in prioritizing multiple projects; adaptability. Ability to comply with sponsor/client/site requirements, including vaccination status or other personal information where required by sponsor or site. Compensation & Benefits
Salary range: Sr CRA (Level I) California: $82,800.00 – $140,000.00; ranges vary by level and location. Variable annual bonus eligibility; comprehensive total rewards package: medical/dental/vision plans, employee assistance, PTO, holidays, parental leave, disability, retirement plan, ESPP, and other benefits. Additional benefits information available on Thermo Fisher total rewards program. EEO Statement
Thermo Fisher Scientific is an EEO/AA 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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Experienced Clinical Research Associate (CRA II, Sr CRA, Principal CRA) – Central and West Coast. The role supports end-to-end clinical trial activities within Thermo Fisher Scientific’s clinical research services portfolio, contributing to study start-up, monitoring, data quality, and study close-out across commercial and government contracts. Responsibilities
Monitor investigator sites with a risk-based approach; apply root cause analysis, critical thinking and problem solving to identify site processes failures and implement corrective/preventive actions to ensure compliance and reduce risk. Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring activities. Assess investigational products through physical inventory and records review; document observations promptly using approved business writing standards. Escalate deficiencies and issues to clinical management and follow through to resolution. Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording between visits. Conduct monitoring tasks per the monitoring plan and participate in the investigator payment process. Collaborate with project team members on issue resolution and follow-up on findings. Participate in investigator meetings and assist in identifying qualified investigators in collaboration with the client company. Initiate clinical trial sites per procedures to ensure compliance with protocol, regulatory and ICH-GCP obligations; make recommendations as warranted. Perform trial close-out and retrieval of trial materials; ensure essential documents are complete and filed per ICH-GCP and regulations. Conduct on-site file reviews as required; provide status updates to the Clinical Team Manager and ensure study systems are updated per study conventions (e.g., CTMS). Facilitate communication between investigative sites, client company and project team; respond to sponsor/client/site audits/inspections. Complete administrative tasks (expense reports, timesheets) in a timely manner; contribute to project publications/tools and process improvement initiatives. Progressively take on increased responsibilities corresponding to CRA level expectations. Qualifications
Bachelor’s degree in life sciences or nursing certification or equivalent; relevant vocational qualification. 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: extensive monitoring experience with broad expertise. Valid driver’s license where applicable. Proven clinical monitoring skills and working knowledge of ICH-GCP and applicable regulations. Strong written and verbal communication, critical thinking, risk-based monitoring knowledge, and ability to work independently or in a team. Work Environment & Requirements
Standard office environment with potential travel; frequent site visits and travel typical to role (approximately 60–80%, with variations). Ability to work in diverse environments; predictability in prioritizing multiple projects; adaptability. Ability to comply with sponsor/client/site requirements, including vaccination status or other personal information where required by sponsor or site. Compensation & Benefits
Salary range: Sr CRA (Level I) California: $82,800.00 – $140,000.00; ranges vary by level and location. Variable annual bonus eligibility; comprehensive total rewards package: medical/dental/vision plans, employee assistance, PTO, holidays, parental leave, disability, retirement plan, ESPP, and other benefits. Additional benefits information available on Thermo Fisher total rewards program. EEO Statement
Thermo Fisher Scientific is an EEO/AA 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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