Opening for the post of Clinical Research Associates/ Senior Clinical Research Associates @ George Clinical
Job description
With recent changes to industry regulatory laws, new projects on the horizon and and the continuous growth of a busy team, we are searching for experienced and motivated mid to senior level Clinical Research Associates to join us in our Bangalore office.
The key responsibilities of the positions will include:
Coordinating the identification, feasibility assessment and selection of investigators and sites to undertake the study
Preparing, organising, 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.
In addition, our Senior Clinical Research Associates 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 and lead by the organisation's values.
Desired Skills and Experience
The ideal candidates will possess:
At least 2 years experience in clinical trial monitoring within a CRO or pharmaceutical environment
Tertiary qualifications in a related science or health care discipline
Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
Excellent interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders
Excellent organisational skills – ability to organise, take initiative and follow-up independently
Familiarity with computer systems particularly MS office, electronic data capture and project management systems
Ability to see the big picture, yet still focus on detail and quality work
Ability and willingness to travel (up to 50%).
Senior candidates should have at least 5 years experience in Clinical Research and demonstrate experience in coaching and mentoring more junior staff members.
You will ideally already be located in Bangalore or willing to relocate.
We offer competitive salary packages, flexible working conditions and opportunities for growth and development.
Follow us on Linkedin to learn more about our unique organisation and projects.
All queries and applications should be directed to Ramya Yadehalli, Human Resources Advisor at ryadehalli@georgeclinical.com.
Please only apply for these roles if you meet the criteria listed above and note that only shortlisted applicants will be contacted.
Click here to apply
Job description
With recent changes to industry regulatory laws, new projects on the horizon and and the continuous growth of a busy team, we are searching for experienced and motivated mid to senior level Clinical Research Associates to join us in our Bangalore office.
The key responsibilities of the positions will include:
Coordinating the identification, feasibility assessment and selection of investigators and sites to undertake the study
Preparing, organising, 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.
In addition, our Senior Clinical Research Associates 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 and lead by the organisation's values.
Desired Skills and Experience
The ideal candidates will possess:
At least 2 years experience in clinical trial monitoring within a CRO or pharmaceutical environment
Tertiary qualifications in a related science or health care discipline
Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
Excellent interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders
Excellent organisational skills – ability to organise, take initiative and follow-up independently
Familiarity with computer systems particularly MS office, electronic data capture and project management systems
Ability to see the big picture, yet still focus on detail and quality work
Ability and willingness to travel (up to 50%).
Senior candidates should have at least 5 years experience in Clinical Research and demonstrate experience in coaching and mentoring more junior staff members.
You will ideally already be located in Bangalore or willing to relocate.
We offer competitive salary packages, flexible working conditions and opportunities for growth and development.
Follow us on Linkedin to learn more about our unique organisation and projects.
All queries and applications should be directed to Ramya Yadehalli, Human Resources Advisor at ryadehalli@georgeclinical.com.
Please only apply for these roles if you meet the criteria listed above and note that only shortlisted applicants will be contacted.
Click here to apply
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