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Clinical Research Associate

Company Name – IQVIA

Location – Maharashtra

Job Description

Qualifications

Bachelor’s Degree Degree in scientific discipline or health care preferred.

Bachelor’s Degree Degree in scientific discipline or health care preferred.

Equivalent combination of education, training and experience may be accepted in lieu of degree.

Some organizations require completion of CRA

training program or prior monitoring experience.

Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good

Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).

Good therapeutic and protocol knowledge as provided in company training.

Computer skills including proficiency in use of
Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

Written and verbal communication skills including good command of English language.

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

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Essential Functions

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.

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