Thermo Fisher Scientific · 16 hours ago
Clinical Research Associate (Level II) - FSP Oncology - Oregon
United States
Full-time
Remote
Mid Level
3+ years expThermo Fisher Scientific is a leading company in the field of scientific research, and they are seeking a Clinical Research Associate (Level II) to monitor investigator sites in the oncology domain. The role involves ensuring compliance with protocols, conducting monitoring tasks, and facilitating communication among project teams and investigative sites.
Research
Responsibilities
Monitors investigator sites with a risk-based monitoring approach: applies root Functions 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
Assess investigational product through physical inventory and records review
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 follow all issues through to resolution
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner
Conducts monitoring tasks in accordance with the approved monitoring plan
Participates in the investigator payment process
Ensures a shared responsibility with other project team members on issues/findings resolution
Investigates and follows-up on findings as applicable
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
Performs trial close out and retrieval of trial materials
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
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
Responds to company, client and applicable regulatory requirements/audits/inspections
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members
Contributes to other project work and initiatives for process improvement, as required
Qualification
Required
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
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
Assesses investigational product through physical inventory and records review
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
Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed
Conducts monitoring tasks in accordance with the approved monitoring plan
Participates in the investigator payment process
Ensures a shared responsibility with other project team members on issues/findings resolution
Investigates and follows-up on findings as applicable
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client company
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations
Performs trial close out and retrieval of trial materials
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
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
Responds to company, client and applicable regulatory requirements/audits/inspections
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members
Contributes to other project work and initiatives for process improvement, as required
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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