Principal Investigator - Research Scientist - Healthcare

Key Responsibilities :

- Responsible for preparation and/or review of relevant standard operating procedures as per the current technicalities with respect to ICH GCP guidelines and other regulatory requirements.

- Training of SOPs to other staff of department.

- Ensure the registration of eligible volunteers as per current SOPs.

- Ensure updating of volunteers data bank.

- Ensure the obtaining of free voluntary consent from volunteers for screening procedures.

- Ensure maintenance of various documents related to registration and screening procedures.

- Ensure coordination with various departments like clinical laboratory, administrative department for proper functioning of screening process.

- Reviewing all data related to screening procedures and declared suitability of volunteers for their participation in the clinical study.

- Ensure confidentiality of all documents related to volunteers- registration and screening procedures.

- To deal with screening failure volunteers as per the relevant SOPs.

- Ensure the preparation and review of clinical studies protocols, informed consent documents and other study related documents as per the requirements of SOPs and different regulatory guideline.

- Ensure that there is an adequate number of qualified trained medical, paramedical and other supporting staff to conduct the study properly and safely.

- Liaisoning with Ethics Committee for seeking IEC approval for conduct of all clinical studies.

- Ensure communications and approval of regulatory body (DCGI), whenever required, (i.e. for T-license application) for the import of investigational products or/and for the conduct of the study at clinical facility.

- Ensure availability of investigational products with necessary documents from sponsor before start of clinical study.

- Ensure proper handling (receipt, storage, accountability, dispensing, disposable etc) of the investigational product as per the relevant SOPs and regulatory requirements.

- Ensure the readiness of facilities with respect to administrative aspects (personnel, equipment, machines etc.), ICU along with emergency drugs, availability of an ambulance services during conduct of study.

- Providing study related information and obtaining free voluntary consent from volunteers for their participation in the study

- Ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product and the study related duties and functions.

- Assign study related activities to qualified trained study personnel for the conduct of clinical study.

- Ensure that the study is conducted in compliance with approved protocols, In house SOPs and applicable regulatory requirements.

- Ensure completion of study related all documents.

- Review the statistically analyzed data of the clinical study.

- Ensure the safety of study subjects including handling adverse events/adverse drug reactions occur with study subjects during conduct of clinical study in consultation with Head-CPU.