Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
Evaluate site practices for protocol adherence and escalate quality issues as needed.
Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.
Mentor clinical staff through co-monitoring and training visits.
Work closely with study team members to support project execution.
Manage site finances and retrieve invoices as per local requirements.

Requirements

BS Degree in a scientific discipline or healthcare preferred.
Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
Proficiency in Microsoft Office.
Excellent communication skills.
Strong organizational and problem-solving abilities.

Benefits

health insurance
retirement plans
paid time off
flexible work arrangements
professional development opportunities

Applicant Tracking System Keywords

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

Hard Skills & Tools

on-site monitoringprotocol trainingdata managementregulatory submissionsrecruitment plansquality issue escalationTrial Master File (TMF)Investigator’s Site File (ISF)oncology protocolsGood Clinical Practice (GCP)

Soft Skills

communication skillsorganizational abilitiesproblem-solving abilitiesmentoringcollaboration