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US-MA-Southborough: Clinical Research Associate II
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please visit http://biotech.fyicenter.com/
Date: 11-Aug-2009
Clinical Research Associate II
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:
Independently performs monitoring visits, including Pre-Study, Study Site Initiation, routine Monitoring and Study Site Closure visits.
Ensures site compliance with study protocols, ICH GCP and applicable regulations. Works with site personnel and Averion study team to prevent and resolve issues.
Documents monitoring activities in monitoring reports and follow-up letters. Communicates serious issues to the Averion study team in a timely manner.
Assists in study start-up activities including site selection and review of regulatory documents and ensures site is qualified for the study.
Performs source data verification of CRFs and DCFs.
Performs investigational product accountability.
Reviews adverse event reports and ensures the site is reporting events appropriately.
Collects data from sites within given timelines.
Maintains regular contact with study site to ensure protocol/GCP compliance, assess subject accrual rates, and respond to sponsor or internal team requests.
Provides coverage for the Lead CRA/CPM to address Sponsor and/or Site queries.
Documents communication with study sites and sponsors in a timely manner.
Reviews protocols and case report forms.
Presents at and participates in Investigator Meetings, other study trainings and meetings as required.
Monitors sites in accordance with Averion Quality Documents and the study monitoring plan
Conducts training visits for more junior Clinical Research Associates and assesses the performance of the trainee.
Acts as a mentor for more junior Clinical Research Associates.
Assists the CPM or Lead CRA with special projects as needed.
Performs all other duties as assigned.
EDUCATION AND/OR EXPERIENCE:
Bachelors degree or combination of equivalent education and experience in a medical or scientific discipline.
Generally will have a minimum of 1-2 years of experience as a field monitor within a CRO or other clinical research setting.
Generally will have a minimum of 2-4 years of total industry-related experience.
ESSENTIAL KNOWLEDGE, SKILLS & LICENSES:
Must have an excellent understanding of ICH GCP and monitoring practices with a track record for ensuring quality data and performing superb site management.
Must have a strong understanding of Medical Terminology, Physiology, and Pathophysiology.
Must be proficient in operating computer applications including Microsoft Office.
Must be organized and able to produce high quality work independently or as part of a team.
Must be able to multi-task and work in a high volume, deadline controlled environment.
Must have excellent writing, verbal communication, interpersonal and diplomacy skills.
Must have professional demeanor and appearance.
MACHINES, OFFICE EQUIPMENT & SOFTWARE:
MS Office (MS Word, Excel, Power Point), Clinical Trial Management System (CTMS)
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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