Clinical Research Associate
3 months ago
**Knowledge and Skills**
Knowledge of medical terminology.
Understanding of clinical trials methodology and terminology.
Understanding and experience in using data standards.
Competent in clinical study management that includes clinical data management.
Generate specifications for EDC build components (e.g., Rights and Roles).
Experience in forms design and layout.
Perform and or support the setup of documents and ensure proper documentation. Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
Perform data review for assigned protocols to ensure data completeness, quality, and accuracy.
Support functional QC activities and testing. Perform user acceptance testing.
Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.
Should have strong written and oral communication skills, with exposure to or basic understanding of clinical trials.
Strong knowledge and experience of EDC systems; demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
Assure the protocol is followed and data is reported accurately, and scientific integrity of the data collected is protected and verified.
Acquire process knowledge from SME (Internal/Client). Participate and successfully complete role related training programs.
Ensure timely and accurate service delivery as per client SLAs and adherence to client contractual commitments.
Provide prompt responses to queries from Internal or External stakeholders.
Follow Data Privacy and Code of Conduct standards.
**Qualifications**
Master’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Nursing.
A medical or pharmacist degree.
A minimum of 5 years of Pharmaceutical Clinical Operations experience is desirable including direct monitoring and clinical trial/study management experience.
**Salary**: ₹400,000.00 - ₹600,000.00 per year
Schedule:
- Monday to Friday
- Night shift
**Experience**:
- total work: 2 years (preferred)
Work Location: In person
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