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Clinical Research Associate/Monitor - Home Based

Job Description

Have you heard? Ockham has merged with Chiltern to lead the industry in Oncology, Source, and Biopharmaceutics development. The new Chiltern is a leading, global, mid-sized CRO focused on providing expertise, engagement, and tailored, responsive solutions to meet the demands of biotech and pharmaceutical partners of all sizes. With a successful track record in both the CRO and resourcing fields, Chiltern (formerly Ockham) is driven by outcome, defined by expertise. One of our clients is looking for a Clinical Research Associate/Monitor. This is a perm position. 

Summary 75% travel

•To ensure data quality at study sites for which CRA is responsible

•To ensure compliance with protocol at site for which CRA is responsible

•To ensure compliance of the sites for which the CRA is responsible with relevant SOPs and regulations


Essential Duties and Responsibilities

•Report all relevant safety information to the PM from the sites for which CRA is responsible

•Monitor patient recruitment timelines at sites for which CRA is responsible and report this information to the PM

•Check the study file periodically to ensure compliance with relevant SOPs and regulations

•Assist with arranging of project kick-off meetings if requested

•Assist with the conduct of ongoing project team meetings (either face to face meetings or teleconferences, depending on the location of the team members), if requested

•Understand the product, protocol and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel

•Conduct site selection activities including attendance at site selection visits

•Prepare ethics submissions

•Provide assistance with regulatory submissions

•Perform site initiation visits

•Write or review protocols

•Write or review case report forms

•Prepare or assist with the preparation of investigator contracts

•Monitor study sites for which the CRA is responsible. This includes but is not limited to checking drug supplies, checking site compliance with protocol and all current and relevant regulations, conducting source data verification, ensuring all serious adverse events (SAEs) have been reported appropriately and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit

•Conduct ongoing CRF discrepancy resolution 

Job Requirements

 

Work Experience and Skill Requirements

At least 2 years of experience as a CRA

2 years of experience working directly for a CRO

Lung cancer experience in Oncology preferred

 

Education Requirements

Bachelor’s degree

 

 

Job Snapshot

Post Date 10/28/2014
Location Nationwide - Home Based, IN
Employment Type Full-Time
Job Type Biotech, Pharmaceutical
Education 2 Year Degree
Experience 2 to 5 years
Manages Others No
Industry Biotechnology, Pharmaceutical
Required Travel Road Warrior
Job ID 5490
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