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| Company: |
Target Search Consulting |
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| Job Title: |
Clinical Research Associate/ Senior CRA |
| Job Category: |
Pharmaceutical |
| Job Location: |
Singapore |
| Job Description: |
Job Purpose
Central point of communication between Pharma and Investigators for all clinical trial related activities to assure trials are conduct on time and budget, while fully GCP, ICH and company SOP compliant.
Major Accountabilities
Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial.
Assume ambassadorial role to facilitate communication between sites and Key line functions to increase value proposition to investigators.
Facilitate preparation and collection of site level documents.
Execute site initiation and training activities.
Perform monitoring visits according to monitoring plan.
Manage site drug supply management .
Resolve site level update of technical systems (Clin Admin, EDC).
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
Manage recruitment implementing appropriate contingency plans as needed.
Assure continual GCP, ICH and SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training.
Author study monitoring reports.
Perform data query resolution process (both at Site and with Data Management).
Execute site closeout activities.
May act as local (or global) CRA Lead, as assigned.
Ideal Background
Education: A degree in a scientific or health care discipline preferred.
Experience:Basic medical and business knowledge. Desired 4+ years experience in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile. Understands and can apply knowledge of clinical trial designs to trial execution. Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations. Expertise in communication, managing multiple priorities
Candidates eligibility for Senior CRS - Minimum 6 years experience, adequate level of proficiency within CRA III competency profile
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| Skills Required: |
Excellent Communication
Preferably should be able to converse in Mandarin |
| Language Requirements: |
English-Very GoodOther: Mandarin
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| Employment Type: |
Full Time
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| Yearly Salary: |
Unspecified
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| Posting Date: |
Apr 24 2008 |
| Education level required: |
Bachelor
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| Experience (in years): |
3 to 5 Years |
| Company: |
Target Search Consulting |
| Contact Name: |
Target Search Consulting |
| Preferred Method of Contact: |
E-mail via Apply Online Box |
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| Jobseekers:69833 |
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Employers:8497 |
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