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 / 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.
Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.
Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and or site specific documents or essential regulatory documents and any updated or amended regulatory documentation.
Seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups. Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research