Specialist Recruiter at ApicalGo Consultancy
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Senior Associate - Clinical Research (5-6 yrs)
- 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.
- Candidates from Bangalore will be preferred.
- Client offers a competitive salary package, flexible working conditions and strong growth and development opportunities.