US-MA-Southborough: Clinical Research Associate II
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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: • Bachelor’s 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)
Thank you,
BioTech FYI Center
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