Clinical Investigator at Gandhidham

Quantys Clinical Pvt. Ltd. (Rusan Pharma) is Hiring for Clinical Investigator Having Experience of Minimum 01 Year- 04 Year at Gandhidham Location.

Department - Clinical

Designation - Clinical Investigator

Qualification - M.B.B.S.

Job Profile -

Compiling the medical examination of volunteers with clinical investigations lab reports for certifying the health status.

Perform medical examination of subjects during check-in and check-out phases

Clinical management of adverse drug reactions and adverse events

To assist principal investigator in the clinical conduct of the study as per protocol

Review of clinical raw data and report, Review and Writing of SOPs.

Clinical feasibility evaluations of conducting BE study for Sponsor interested molecules.

Propose study designs, reviewing and finalizing Protocol, ICFs and CRFs prepared as per regulatory requirements in congruence with Sponsor requirements.

Obtaining the sponsor signatures and finalizing other study related documents and making the IEC submission for getting timely approvals from the IEC. Follow up with IEC for early and timely approvals or query resolutions.

Receiving Investigational products from the sponsor after approval of Protocol by the IEC and the DCGI.

Sharing and discussing with the dietitian required protocol information and diet requirements for getting the meal menu prepared by Dietician and making it available with canteen as needed.

Providing necessary inputs to biostatistician for getting the randomization schedule from biostatistician make it available with Pharmacist after review for dispensing.

Imparting Protocol Training to the study personnel and delegations of duties.

Assessing and planning volunteer requirement, supervising and overseeing registration of volunteers, screening, check-in, dosing, adverse event handling, reporting, monitoring and follow up, checkout procedures. Review of Screening lab reports and Post study lab reports along with the evaluations.

Interested Candidate share updated CV at : mayur.hadiya@quantysclinical.com

Mobile : 9913468943