Company
Biotech
SeniorClinicalResearchAssociate-Oncology-FSP
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Research Associate - Oncology - FSP. Skills: Clinical monitoring, Oncology monitoring, Site management, ICH-GCP compliance. Lead site management activities. Conduct on-site monitoring visits”
Industry & Context.
Problem-solving skills
Willingness to travel
What They're Looking For.
Must Have
Bachelor’s degree in scientific, life sciences, or healthcare-related field, 5+ years clinical monitoring / CRA experience, 2+ years oncology monitoring experience, Knowledge of ICH-GCP guidelines, Knowledge of clinical trial processes, Knowledge of applicable regulatory requirements, Experience with risk-based monitoring approaches, Experience with remote monitoring activities, Experience with on-site monitoring activities, Ability to perform SDV, Ability to perform SDR, Ability to perform CRF review, Ability to manage complex site-level documentation, Understanding of clinical study management, Understanding of drug accountability, Understanding of data integrity principles, Proficiency in English (written and spoken)
Nice to Have
Additional local language fluency is an advantage
What You'll Do.
Lead site management activities
Conduct on-site monitoring visits
Conduct remote monitoring visits
Ensure compliance with ICH-GCP guidelines
Ensure compliance with study protocols
Ensure compliance with client SOPs
Ensure compliance with regulatory requirements
Serve as primary point of contact for sites
Provide training to investigators
Provide guidance to investigators
Provide support to investigators
Provide training to site staff
Provide guidance to site staff
Provide support to site staff
Perform risk-based site assessments
Adjust monitoring strategies
Update clinical systems
Ensure timely resolution of data queries
Ensure timely resolution of outstanding actions
Manage investigational product accountability
Manage study supplies
Ensure proper handling at site level
Ensure proper documentation at site level
Support Serious Adverse Event reporting
Ensure timely follow-up of safety information
Ensure timely documentation of safety information
Prepare monitoring visit reports
Finalize monitoring visit reports
Submit monitoring visit reports
Prepare follow-up letters
Finalize follow-up letters
Submit follow-up letters
Ensure required documentation is complete
Ensure required documentation is audit-ready
Participate in study team meetings
Contribute to recruitment strategies
Escalate quality risks
Ensure inspection readiness of sites
Ensure proper maintenance of essential documents
How You'll Work.
Team & Collaboration
Site personnel; Internal teams; Study team meetings; Cross-functional teams
Communication Scope
Relationship-building
Full Job Description
## Accountabilities Lead site management activities including selection support, initiation, monitoring, and close-out of clinical trial sites in accordance with study protocols and regulatory requirements. Conduct on-site and remote monitoring visits, including source data verification (SDV), source data review (SDR), and Case Report Form (CRF) review as per monitoring plans. Ensure compliance with ICH-GCP guidelines, study protocols, client SOPs, and applicable regulatory requirements throughout all study activities. Serve as the primary point of contact for assigned sites, providing training, guidance, and ongoing support to investigators and site staff. Perform risk-based site assessments and adjust monitoring strategies to ensure quality and compliance. Track study progress, update clinical systems (e.g., CTMS), and ensure timely resolution of data queries and outstanding actions. Manage investigational product accountability, study supplies, and ensure proper handling and documentation at site level. Support Serious Adverse Event (SAE) reporting and ensure timely follow-up and documentation of safety information. Prepare, finalize, and submit monitoring visit reports, follow-up letters, and ensure all required documentation is complete and audit-ready. Participate in study team meetings, contribute to recruitment strategies, and escalate site issues or quality risks as needed. Ensure inspection readiness of sites and proper maintenance of essential documents within the eTMF. Requirements Bachelor’s degree in a scientific, life sciences, or healthcare-related field. Minimum of 5+ years of clinical monitoring / CRA experience in a CRO or pharmaceutical environment. At least 2+ years of oncology monitoring experience required. Strong knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulatory requirements. Experience with risk-based monitoring approaches, including remote and on-site monitoring activities. Ability to perform SDV, SDR, CRF
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