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MS Office - Administrator
(Jobs in RALEIGH, NC)
 
Requirement id 8548
Job title Administrator
Job location in Raleigh, NC
Skills required MS Office, 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 Administrator: MS Office, Clinical Experience, -,

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

[Note : Start Date : 02-27-2012
End Date : 02-28-2013]

Description :

Title: Clinical Research Associate II
Department: Clinical Research
Location: USA - Southeast - Home Based
Employment Type: Full Time
Job Type: Regular
Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the worlds top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
Description:
Essential Function

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Key Accountabilities


Assume the ability to meet the requirements of a CRA I with a high degree of proficiency and autonomy
Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
Train team members on selected tasks
Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
Build relationships with investigators and site staff
Participate in Investigator and other external or internal meetings as required
Arrange on-site visits and logistics (e.g. travel arrangements)
Perform on site visits in accordance with the monitoring plan
Conduct on-site study-specific training (if applicable)
Perform site facilities inspection
Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
Collect SRP documents during QV and other visits as needed
Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
Update all relevant tracking system on an ongoing basis
Collaborate with CMA on site issues/actions
Generate visit/contact report in accordance with monitoring plan
Code and scan Central File documents where applicable
Ship relevant wet-ink signature documents to the Assistant or back to the site
Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead
Attend audits / Regulatory Inspection if requested

Experience:
Skills


Strong computer and internet skills including knowledge of MS Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Looks for win-win solutions to solve problems
Gives others appropriate latitude to make decisions
Carefully weighs the priority of project tasks and directs team accordingly
Understands th
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 8548 while calling.
 
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(Administrator: MS Office, Clinical Experience, -, in Raleigh, NC)
     
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