A leading global CRO, PRA is transforming clinical trials through our people, innovation and transparency. We serve clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge
PRA’s commitment to excellent in research begins with our people. Our workforce has grown by over 25% since 2010 and now comprises over 4,700 employees spanning more than 13 time zones and speaking more than 15 languages.
It is our philosophy that the way in which we grow our business is to focus on our employees and as such, we recognize that successful careers are found within organisations that provide the support that employees need at work, as well as the benefits they require outside the office.
Post: In-House Clinical Research Associate 1
Job Description:
- Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
- Utilizes the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.
- Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
- Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Documents site and Sponsor contact and study interactions in a timely and professional manner.
- Assists with resolution of investigational site/data queries.
- Liaises with project team members regarding study site issues.
- Provides quality review of the informed consent template.
- Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study.
- Follows up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments.
- Performs other duties as assigned.
Candidate Profile :
-0 – 2 years of related experience
- Prior experience using computerized information systems.
- Read, write, and speak fluent English; fluent in host country language required
- Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
- Clinical trials support or pharmaceutical industry experience preferred.
- Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
- Office based or clinical employment experience preferred.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
Additional Information:
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 5th June, 2017
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