Senior Clinical Trial Monitor - Los Angeles, United States - ALKU

Description

Clinical Monitor (West Coast highly preferred)

Background:
Our client is a small medical device and aesthetics manufacture that focuses on breast reconstruction clinical studies.

They have a long-term Post Marker clinical study that is currently ongoing, and they are looking for a field clinical monitor to come on and help with clinical monitoring.

This role would require travel to Mid-West & West Coast based clinical sites where this consultant would work heavily with site personnel to file patient diaries for Class III devices.

This consultant will also be responsible for then reporting within EDC systems such as VeevaVault and Medidata Rave.

Responsibilities:
Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
Ensures integrity of CRF data through source document review and verification
Reviews regulatory binder for required documents
Works closely with in-house CRAs and data management to resolve queries on discrepant data
Proactively identifies site issues and develops problem-solving strategies for sites
Maintains regular contact with study sites and site personnel to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests
Manages and resolves conflicting priorities to deliver on commitments
Complies with ICH GCP guidelines, FDA regulations, and company SOPs

Required Skills:
Mid-West & West Coast Based Travel
Class III Medical Device Experience
Clinical Monitoring
Dermatology/Breast Implant Experience (Bonus)
Medidata Rave & VeevaVault Familiarity


Highly Preferred:
Open to traveling on the west coast a few times a month
Local to San Diego or Irvine, CA area.

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