As a Sr. CRA, working as a Senior Site Monitor exclusively assigned and embedded within a Pharmaceutical Company you will be responsible for successfully performing site monitoring and site management activities related to the assessment, initiation, conduct, and closure of assigned sites in Phase I-IV studies.
The Senior Site Monitor is responsible for managing assigned sites within timelines and quality standards, and for adhering to monitoring procedures in compliance with ICH GCP, local regulations, SOPs, and study-level functional plans.
Accountabilities:
- As assigned to support study execution teams, responsible for the implementation of Site Monitoring and Site Management activities
- Conducts site visits on-site and remotely to confirm initial and ongoing site suitability and to assess study conduct. Includes pre-study, site initiation, interim monitoring, site close-out, and monitoring oversight visits.
- Follows study-specific site monitoring plans to assess and support sites’ compliance with the protocol, data quality, and participant safety - via the review of site and subject records. This includes but is not limited to source data verification, source data review, investigator site file review, and drug accountability activities.
- Develops and sends confirmation and follow-up letters to provide clear communications with sites and documents all site interactions in appropriate site monitoring visit report documentation per requirements in systems.
- Completes initial and ongoing study training; delivers and documents relevant study training with site personnel.
- Reviews systems and dashboards to prepare for site interactions and to assess site compliance with study requirements (e.g., EDC status as well as eCOA compliance). Partners with RBQM Operations to address centralized monitoring findings with sites, and support sites in RBQM processes.
- Provides ongoing site support / management, liaising with sites to address questions, triage study needs, and resolve issues with and for sites. Escalates site issues as needed to Clinical Operations representatives (e.g., CSSM, CSM, RBM Lead).
- Conducts Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality for additional sites/studies as requested.
- Maintains high quality, consistency, and compliance with procedures across studies
- Recommends monitoring process adjustments based on experience during and after the completion of study activities
- Acts as a change agent, subject matter expert, and point of contact for risk-proportionate site monitoring concepts with study teams
- Supports and participates in internal and external audits and inspections as requested
Education & Competencies (Technical and Behavioral):
Education: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Experience:
- Minimum of 5 years of experience in Site Monitoring / Site Monitoring Management, or Risk Based Monitoring roles with Sponsors or CROs
- Robust understanding of the drug development and clinical trial execution processes
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
Skills:
- Experience successfully delivering site monitoring and risk-based monitoring, including onsite and remote monitoring models
- Experience in navigating external vendor portals / reports, and knowledge of Veeva EDC, TMF, and CTMS
Behavioral Competencies:
- Pragmatic and comfortable with evolving processes; willing to drive and support change
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Clear communication style with a demonstrated ability to think critically, collaborate, and influence without authority
- Ability to embrace and demonstrate a growth mindset focused on diversity and inclusion
Travel Requirements:
- Requires minimum 50% travel, including overnight and potentially international travel
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