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| Company: |
Makro Technologies |
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| Job Title: |
Clincial research Associate |
| Job category: |
Biotech |
| Job Location: |
Memphis - TN Tennessee - USA |
| Job Reference Number: |
14477 |
| Job Description: |
Dear Candidate,
We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known IT and Life Science Organizations throughout United States. Our broad geographic reach, scalability and immense talent pool enable us to reliably meet the needs of enterprise-level clients. We thoroughly understand and believe that long lasting in-depth relationships with clients is an integral part in the business environment and equally important is the relationship with our candidates.
Our vision is to become a most reliable `connector` between our clients and Talent pool i.e. ` YOU `.
We have following opportunity currently available for you.
Job Title : Regional CRA
Position Type : Contract
Location : Ft. Myers
Duration : 9 Months
Full Requirement:
Description
Duties:
Ø ***Candidate MUST be located in Ft. Myers, FL or very local surrounding area.
Ø Contractor will need to travel home every night.
Ø ***Will need to use own laptop.
Ø ***Must have 4 years (at least) of monitoring experience and at least 2 years of oncology monitoring experience.
Ø Contract Regional Clinical Research Associate is regionally based and responsible for the monitoring activities in compliance with FDA regulations, ICH/GCP guidelines and sanofi-aventis SOPs, to support US and Global Medical Affairs trials. This candidate will be part of the Oncology therapeutic area team. Primary functions of this position will include evaluating, initiating, monitoring and performing close-out visits for clinical investigative sites. Successful candidate will monitor and manage all assigned clinical study sites to ensure subject safety and the timely delivery of project milestones.
Ø Monitor multiple investigational sites within the oncology group in accordance with State and Federal Regulations, Good Clinical Practices and Standard Operating Procedures.
Ø Work to ensure consistent implementation and successful completion of clinical research activities for assigned studies by conducting site initiation visits, routine monitoring visits, closeout visits and booster visits in accordance with the monitoring plan and sanofi-aventis SOPs.
Ø Act as primary liaison between assigned sites and Regional Site Manager.
Ø Communicate effectively with investigators and other research personnel, maintaining a professional demeanor.
Ø Perform source document verification of CRFs according to SOPs and study specific requirements.
Ø Ensure Case Report Forms (CRFs) are complete, legible and accurately reflect the source data.
Ø Ensure appropriate reporting of adverse events by investigators according to GCP and SOPs.
Ø Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies.
Ø Monitor SAE reporting and request primary and follow-up information according to SOP.
Ø Review protocol violations with the investigator and take corrective actions to ensure future compliance.
Ø Responsible for the reconciliation of drug accountability records at sites.
Ø Responsible for the reconciliation of all regulatory documents at sites.
Ø Provide timely monitoring reports in accordance with SOPs.
Ø Participate in clinical study team meetings.
Ø Assist Data Management in the resolution of data queries.
Ø Ensure availability of all study supplies at sites and participate in other tasks as needed.
Skills:
Experience:
Ø Must have at least 4 years monitoring experience.
Ø Minimum of two years experience monitoring clinical studies in the oncology therapeutic area.
Ø Good understanding of the clinical development process, GCPs/ ICH/CFR regulations.
Ø Knowledge of RECIST criteria; various oncology therapeutic area expertise, differing by study/tumor type.
Ø Ability to utilize various electronic systems - intermediate computer skills required.
Education:
Ø BA, BS in a relevant scientific discipline required. • CCRA Certified preferred
*** MAKRO is an INC 5000 company for 2007 and 2008***
*** MAKRO is a 3-time FAST 50 technology firm in NJ for 2005/2006/2007 (awarded by Deloitte) ***
*** MAKRO is a 3-time FAST 500 technology firms in USA for 2005/2006/2007 (awarded by Deloitte) ***
MAKRO Companies:
MAKRO Technologies, Inc.
Vernascientific
MAKROcare.
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Language Requirements: |
English-Good |
| Employment Type: |
Contract |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-03-10 |
| Level of Education: |
Bachelor |
| Years of Work Experience: |
3 to 5 Years |
| Job also available in: |
Fort Meyers, FL |
| Company: |
Makro Technologies |
| Contact Name: |
Makro Technologies |
| Contact Phone: |
973-481-0100 x 3074 |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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