Clinical Research Associate/Senior Clinical Study Manager
1 day ago
KlinEra Global Services is a leading provider of innovative clinical trial and research services. As a Clinical Research Associate/Senior Clinical Study Manager, you will play a vital role in ensuring the success of our studies.
About the Role
The ideal candidate will have extensive experience in oncology trials, with a strong understanding of Indian regulations and their practical implementation. You will be responsible for conducting site qualification visits, initiation visits, interim monitoring visits, and close-out visits to ensure compliance with GCP and ICH guidelines. Additionally, you will review source data and case report forms for accuracy, completeness, and integrity, and identify and resolve ongoing data issues.
Duties and Responsibilities
- Conduct remote and on-site monitoring visits to ensure compliance with protocol requirements
- Review and report on site recruitment efforts, enrollment metrics, and serious adverse events
- Identify and resolve data discrepancies and perform data queries and listings
- Oversee the transmission of study data according to protocol-specified timelines
- Maintain consistent contact with study site staff, including investigators, coordinators, and other individuals involved in the clinical study
- Timely visit report writing and site correspondence
Requirements
- Extensive Phase I, II, and III experience in oncology trials
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
- Flexibility with changing priorities
- Ability to efficiently perform and prioritize multiple tasks
- Computer proficiency in Microsoft Word, Excel, and PowerPoint
What We Offer
We offer a competitive salary of $80,000 - $100,000 per annum, depending on experience, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply.
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Mumbai, Maharashtra, India KlinEra Global Services Full timeAbout KlinEra Global ServicesKlinEra Global Services is a renowned provider of innovative clinical trial and research services. Established in 2005, our company has been delivering efficient and ethical clinical trials that accelerate the delivery of novel therapeutic treatments.With extensive experience in various therapeutic areas, our team ensures...
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Mumbai, Maharashtra, India KlinEra Global Services Full timeAbout KlinEra Global Services: Established in 2005, KlinEra Global Services provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate delivery of novel therapeutic treatments with faster patient access.KlinEra Global Services has extensive experience in a diverse number of...
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Mumbai, Maharashtra, India KlinEra Global Services Full timeAbout KlinEra Global Services: Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that accelerate delivery of novel therapeutic treatments with faster patient access.KlinEra has extensive experience in a diverse number of therapeutic areas for the last two...
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Mumbai, Maharashtra, India KlinEra Global Services Full timeAbout KlinEra Global ServicesWe are a leading provider of innovative clinical trial and research services, established in 2005. Our mission is to accelerate the delivery of novel therapeutic treatments by conducting efficient and ethical clinical trials.KlinEra has extensive experience in a diverse range of therapeutic areas, ensuring compliance and...
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Mumbai, Maharashtra, India KlinEra Global Services Full timeAbout KlinEra Global Services: A leading provider of innovative clinical trial and research services, established in 2005. Our mission is to accelerate the delivery of novel therapeutic treatments through efficient and ethical clinical trials.We have extensive experience in a diverse range of therapeutic areas, ensuring compliance and optimal delivery. Our...
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