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MS Office GCP Analyst
(Jobs in RALEIGH, NC)
 
Requirement id 8549
Job title Analyst
Job location in Raleigh, NC
Skills required MS Office, GCP, Clinical Experience,
Open Date 17-Feb-2012
Close Date
Job type Contract
Duration 12 Months
Compensation DOE
Status requirement ---
Job interview type ---
   Email Recruiter: coolsoft
Job Description Analyst: MS Office, GCP, Clinical Experience,

[**Note : Dead Line : 02/22/2012**]

[Note : Start Date : 02-13-2012
End Date : 02-27-2013]

Description :

X The role of the Clinical Data Analyst (CDA) is to perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.

Position Responsibilities

X Key activities include data validation, generation and integration of queries, coding of clinical data, reconciliation of safety and electronic data.
X The Clinical Data Analyst will assume the Clinical Data Manager responsibilities on studies.
X Comply with Company policies, SOPs and Regulatory guidelines.
X Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
X Conduct in-house data review.
X Generate and close queries or apply self evident corrections to the data according to the relevant guidelines.
X Identify and report protocol violations.
X Manual and Patient Profile review, issue queries.
X Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.

Track and integrate queries :

X Perform clinical coding if appropriate to role within the project team.
X Ensure all documents coded for submission to central files.
X Lock site(s) within EDC system - remove users data modification privileges.
X Interact with site (via mail) as required.
X Perform early and final database QC activities.
X Update all relevant tracking system on an ongoing basis.
X Inform responsible CDA coordinator of work status regularly.
X Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor.
X Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and WSOP and stud specific procedure.
X Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.

Position Requirements :

X Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, MS-Office products such as Excel, Word.
X Demonstrate a sound awareness of all relevant regulations, including GCP.
X Ability to successfully work in a (virtual) team environment.
X Client focused approach to work.
X If required, knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG).
X Solid interpersonal, verbal and written communication skills.
X Sense of urgency in completing assigned tasks.
X Meticulous attention to detail.
X Effective time management in order to meet daily metrics or team objectives.
X Shows commitment to and performs consistently high quality work.
X Education: Bachelors degree and / or other medical qualification or relevant DM experience.
X Language Skills: Competent in written and oral English.
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 8549 while calling.
 
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(Analyst: MS Office, GCP, Clinical Experience, in Raleigh, NC)
     
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