1 Clinical Site Monitor Job in Laguna Hills, CA

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Clinical Site Monitor

Adagio Medical

Laguna Hills, CA | Full Time

$97k-120k (estimate)

11 Months Ago

Clinical Site Monitor

Adagio Medical Laguna Hills, CA

$97k-120k (estimate)

Full Time 11 Months Ago

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Adagio Medical is Hiring a Clinical Site Monitor Near Laguna Hills, CA

JOB TITLE: Clinical Site Monitor

DEPARTMENT: Clinical Affairs

REPORTS TO: Clinical Trials Manager

JOB SUMMARY

The Clinical Site Monitor is responsible for assurance of clinical trial site regulatory compliance and quality of clinical trial data via query resolution an on-site source data verification. This person is also responsible for site close-out activities.

DUTIES AND RESPONSIBILITIES

Participates in clinical site selection, qualification, initiation, activation and close-out activities

Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements

Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigational sites

Conducts interim monitoring visits on-site and remotely to complete clinical site and data monitoring and associated monitoring visit reports

Evaluates clinical data and coordinates data query resolutions

Performs source data verification

Required travel to investigative sites up to 75%

REPORTING

This position will report to the Adagio Medical Clinical Trials Manager.

JOB QUALIFICATION REQUIREMENTS

>1.5 years field-based clinical trial monitoring experience or equivalent experience in clinical trials project management
Experience with electronic data capture (EDC) applications, knowledge of key areas of Compliance
Strong understanding of Good Clinical Practice (GCP), Good Documentation Practice (GDP) and FDA Code of Federal Regulations (GCP certification required)
Strong communication skills as single point of contact for investigator
Excellent organizational skills with high attention to detail
Ability to manage, prioritize, and routinely report progress on projects and tasks
Skilled in building and maintaining relationships with investigational sites

Job Summary

JOB TYPE

Full Time

SALARY

$97k-120k (estimate)

POST DATE

06/03/2023

EXPIRATION DATE

05/16/2024

WEBSITE

adagiomedical.com

HEADQUARTERS

Laguna Hills, CA

SIZE

50 - 100

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