- Coordinating the identification, feasibility assessment and selection of investigators and sites to undertake the study preparing, organizing, conducting and follow-up of site evaluation visits, site initiation visits, routine monitoring and close-out visits as per relevant study plan

- Motivating and training investigators and site staff to ensure obligations in regards to study timelines

- Ensuring ethics submissions are made by investigator sites in a timely manner

- Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting

- Verifying quality, accuracy, completion, and timeliness of data

- Completely and efficiently resolving data and audit queries and issues

- Adherence to the study protocol and study procedures manual

- Compliance with mandatory SOPs as agreed for the study

- Completing all reports accurately and within the predetermined timelines

- Maintaining study information using the clinical trial management system

- Experience in monitoring Cardiology, Nephrology studies are preferred.

Additionally, Senior Clinical Research Associate will be :

- Mentoring, coaching and training junior staff members as directed by line management

- Reporting to regulatory authorities on the progress of clinical trials as required

- Demonstrate and lead by the organization's values.

Ideal candidate will possess :

- At least 5-6 years of proven Clinical monitoring experience, working on clinical projects within a CRO or pharmaceutical environment

- Tertiary qualifications in a related science or health care discipline

- Excellent organization and problem-solving skills

- Highly developed communication skills including verbal, written, and presentation

- Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions

- Demonstrated customer service focus

- Understanding of academic research is desirable

- Technological proficiency including Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project), clinical trials management software and the Internet

- Ability to travel domestically and internationally.

Note :

- Candidates from Bangalore will be preferred.

- Client offers a competitive salary package, flexible working conditions and strong growth and development opportunities.

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