Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
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, case report form (CRF) completion, and data query resolution.
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH and local regulations.
Mentor clinical staff through co-monitoring and training visits.
Work closely with study team members to support project execution.

Requirements

BS Degree in a scientific discipline or healthcare preferred.
At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
In-depth understanding of GCP and ICH guidelines.
Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
Strong written and verbal communication skills with a good command of the English language.
Excellent organizational and problem-solving skills.
Effective time and financial management abilities.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

on-site monitoringprotocol trainingregulatory submissionsrecruitment plansdata query resolutionprotocol adherencecase report form (CRF) completionTrial Master File (TMF)Investigator’s Site File (ISF)Good Clinical Practice (GCP)

Soft Skills

written communicationverbal communicationorganizational skillsproblem-solving skillstime managementfinancial managementrelationship buildingmentoringcollaborationexpectation management