
cliantha research limited
As a Clinical Research Associate II at Cliantha Research, you would be responsible for overseeing and monitoring clinical trials to ensure that they are conducted in accordance with ethical and scientific standards. This would involve tasks such as reviewing study protocols and case report forms, monitoring clinical sites, and ensuring that data is accurate and complete. To be successful in this role, you should have a good understanding of clinical research regulations and experience in clinical trial monitoring. Additionally, strong communication, organizational, and problem-solving skills would be essential.
Department & Qualification: As a Clinical Research Associate II in the Clinical Trials department at Cliantha Research, you would need to have a Bachelor’s or Master’s degree in Pharmacy or Master of Science.
Experience: The required experience for this role is 2 to 4 years in site monitoring, which involves overseeing and monitoring clinical trials at various sites to ensure that they are being conducted according to the study protocol and regulatory guidelines.
Job Location:The location of this position is Ahmedabad, India.
As a Clinical Research Associate II at Cliantha Research, you will play a crucial role in ensuring the successful conduct of clinical trials.
Responsibilities:
Your key responsibilities will include:
- Identifying and qualifying potential investigators to ensure their ability to fulfill the study requirements.
- Collecting necessary documents and submitting them to the Project Manager for approval.
- Supporting Regulatory and EC submissions and generation of Financial Agreements.
- Negotiating study budgets with investigators and ensuring timely payments to sites.
- Training site study teams and conducting start-up activities.
- Participating in investigator meetings and presenting study updates.
- Conducting monitoring visits to check compliance with study management, protocol, and requirements.
- Maintaining Central Investigator Files and ensuring accuracy of source documents.
- Collecting CRFs, DCFs, SAE reports, and other trial-related documents.
- Coordinating with labs and other trial-related services as per study requirements.
- Managing IP accountability and clinical trial supplies.
- Escalating site and project-related issues to the Project Manager.
- Conducting site closeout and follow-up activities.
- Attending staff meetings and training sessions.
- Assisting with audits and liaising with Quality Assurance personnel.
- Collaborating with other departments within the organization.
- Adhering to organization’s rules, policies, and SOPs.
Overall, as a Clinical Research Associate II, you will be a critical member of the clinical trials team and play a vital role in ensuring that trials are conducted in accordance with ethical and scientific standards.
Candidates who are interested in the Clinical Research Associate II position at Cliantha Research can send their resume to apurohit@cliantha.com for consideration.
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To apply for this job email your details to apurohit@cliantha.com