Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
Develop and cultivate strong site relationships and ensure continuity of site relationships
Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
Identify, assess, escalate and resolve site performance or quality issues in a timely manner
Complete feasibility and site identification activities for new clinical studies
Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance Responsible for the development of site specific recruitment, retention and follow-up plans
Facilitate and support investigator site audits and/or inspection activities as needed
Perform remote data review and query resolution for designated sites
Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
Coach and mentor colleagues as needed
Contribute to the review of Codera’s systems and procedures as needed
May be involved, when needed, in other areas of study management and staff training
Execute other duties as assigned

Requirements

Bachelor’s Degree in a Life Science discipline required
Bachelor’s Degree in Nursing or RN a plus
Minimum 3 years of direct site monitoring experience required
Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations
Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
Detail-oriented, organized and committed to quality and consistency
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Excellent team-interaction skills and ability to work successfully in team settings
Ability to work in a dynamic environment with a high degree of flexibility
Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
Excellent written and verbal communication skills
Experience and proven proficiency in CTMS and eTMF systems preferred
Must be willing and able to travel up to 50-65%

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical site monitoringsource data verificationfeasibility assessmentregulatory submissiondata entry managementrisk mitigationstudy level metrics interpretationclinical trial agreementsdrug development understandingprotocol conduct

Soft Skills

critical thinkingdetail-orientedorganizedresults-driventeam interactionflexibilitycommunicationcoachingmentoringprocess improvement

Certifications

Bachelor’s Degree in Life ScienceBachelor’s Degree in NursingRN