Clinical Research Associate

An initiation Clinical Research Associate (iCRA) specializing in Pre SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre SIV and Activation tasks of the study. The iCRA also supports submission and approval process for the protocol amendments if applicable.

Bachelors in Life Sciences with relevant clinical trial monitoring or clinical trial/study coordinator, or clinical trial/study associate experience. Masters degree/ diploma, life sciences, pharmacy, public health, healthcare

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Masters degree/ diploma, life sciences, pharmacy, public health, healthcare for clinical trial monitoring or clinical trial / study coordinator, or clinical trial/study associate. THSTI

Masters degree/ diploma in life sciences, pharmacy, public health, healthcare or other related discipline

Any Post graduate degree in life sciences, Minimum 4 years experience.

Masters Degree / PG Diploma in Life Sciences / Biomedical Sciences / Pharmacy / Public Health / Clinical Research with experience in clinical project management and/or clinical trial/ study monitoring.

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Conduct site monitoring visits from initiation through closeout, ensuring trials are conducted in compliance with the study protocol, GCP guidelines, SOPs, and applicable regulatory requirements. Set up trial sites, ensuring that investigational products and essential trial supplies are delivered, stored, and documented appropriately.