Clinical Research Associate

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.

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

Maintaining detailed records of studies as per FDA and other required guidelines, including things such as drug administration and subject specific case report forms.