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 world's 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.
POSTS:
GCP Auditor {Below}
Clinical Monitoring Associate II
Research Operations Assistant
Post: GCP Auditor
Job Description:
- Plan and conduct audits independently
- Draft and finalize audit reports
- Work closely with Project Management, Clinical (Study) Operations, Quality Management and Quality Assurance (Research Regulatory compliance) groups
- Travel to perform audits (e.g Investigator Site audits)
- Use in-depth understanding of appropriate GCP compliance and other applicable regulations and laws to provide guidance to PAREXEL and our clients regarding compliance issues
- Develop a good knowledge of PAREXEL SOPs and promote SOP compliance
Candidate Profile:
- Bachelor's degree in life science or equivalent work experience
- Substantial experience in GCP audits
- Excellent interpersonal, verbal and written communication skills
- Ability to develop relationships with culturally diverse groups, stakeholders within PXL and clients
- Excellent analytical skills
- Excellent organization skills, ability to manage multiple tasks or projects and prioritize a workload
- Solid knowledge of GCP, ICH and FDA regulations and guidelines
- Ability to travel frequently
- Familiarity with the pharmaceutical industry
- Ability to work professionally with highly confidential information
- Well-experienced with Microsoft Office suite of products (Excel, Access, PowerPoint, Outlook and Word)
- Excellent language skills in English, second language desirable
Team player
Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th May, 2012
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Post: Clinical Monitoring Associate II
Job Description:
- To take responsibility for specific tasks on projects, or acts as the mail CMA contact on individual projects
- Train team members on selected tasks
- Collaborate with CRA on site issues/ actions
- Create and distribute study documents
- Responsible for the completeness and quality of the in-house site specific files
- Update all relevant tracking system on an ongoing basis
- Maintain site staff details
- Perform regular reviews of data according to data review/ monitoring guidelines.
- Conduct remote visits
- Collect updated/ amended regulatory documents in collaboration with CRA and CTS as needed
- Primary in-house site support
- On a regular basis conduct outbound and receive inbound call in order to address pending issues, request outstanding documents, review site payment status, follow up on data entry, query status and SAEs.
- Follow- up on appropriate site related questions
- Build relationships with investigators and site staff remotely.
- Inform responsible COL/CMA coordinator (as appropriate) of work status regularly.
- Keep manager informed about work progress and any issues to avoid surprises.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and study specific procedure.
- Complete routine administration tasks in a timely manner.
Candidate Profile:
- Substantial Monitoring Experience in-house or on-site
- Educated to minimum of graduation in life Science or equivalent
Additional Information:
Location: Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th May, 2012
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Post: Research Operations Assistant
Job Description:
- Central filing Management (labeling ,transmittal forms and sending to central hub),
- Safety Reports (downloading and Distributing SUSARs to sites as per study guidelines),
- General correspondence (site correspondence cover letters)
- In-house communication (communicating with the team members and assisting CRA with entries in CIMS (IMPACT Harmony or other system), perform QC check when requested.
- Naming conventions and PMED uploading.
- Assigned tasks could include: photocopying, binding, tracking, filing, faxing and also submissions of booking forms, invoices etc
Candidate Profile:
From Science Back-ground with Experience in Filing and basic knowledge of computers
Additional Information:
Location: Bangalore
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 20th May, 2012
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