Upendar. B Email & Phone Number

India

Hyderabad, Telangana, India

Hyderabad Area, India

Hyderabad Area, India

Study in charge, which includes Planning and presentation of clinical research study information, Obtaining Informed Consent, Supervision of study related activities and Clinical data review (Compliance with Protocol, GCP).• Execute the studies as per protocol, SOPs, GCP and other regulatory requirements.• Preparation and Review of SOP’s according to the Regulatory requirements. • Presentation of Informed Consent form to the volunteers / study subjects.• Coordinating and being responsible for the designing and preparation of Clinical Study reports, Protocols and summary reports as per regulatory requirements.• Communication of Study Updates with Investigators, Sponsor and Project management.• Reporting of the Adverse Events and Serious Adverse Event to the Sponsor and IEC• Co ordination with all concerned departments for proper planning & execution of studies.• Query resolution management of the audits related to clinical aspects and other issues in coordination with quality assurance department.

Hyderabad, Telangana, India

Name has been changed from RA chem to Cohance

Hyderabad Area, India

Hyderabad Area, India

To conduct site specific audits for the clinical trial/Patient PK trial studies conducted at various identified trial sites• Review Trial master file, paper CRF/eCRF, source data for completeness and Verification.• Scheduling site audits, Preparing Audit Reports, receiving of the responses and verification.• Follow-up of the corrective/Preventive Actions and Issuance of audit certificate. • Checking and issuing of clinical trial related label sheets and applicable forms.• Release of the subject concentration to the bio-statistics department for further analysis and report generation.• To assist and coordinate during the external audits by sponsor/client and regulatory audits• Review of instrument /equipment qualification documents, c

Hyderabad Area, India

Study in charge, which includes Planning and presentation of clinical research study information, Obtaining Informed Consent, Supervision of study related activities and Clinical data review (Compliance with Protocol, GCP).• Execute the studies as per protocol, SOPs, GCP and other regulatory requirements.• Preparation and Review of SOP’s according to the Regulatory requirements. • Presentation of Informed Consent form to the volunteers / study subjects.• Coordinating and being responsible for the designing and preparation of Clinical Study reports, Protocols and summary reports as per regulatory requirements.• Communication of Study Updates with Investigators, Sponsor and Project management.• Reporting of the Adverse Events and Serious Adverse Event to the Sponsor and IEC• Co ordination with all concerned departments for proper planning & execution of studies.• Query resolution management of the audits related to clinical aspects and other issues in coordination with quality assurance department.

B-Pharmacy, Pharmacy

M Pharmacy