Clinical Investigator at Gandhidham
2 weeks ago
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.
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.
Mobile : 9913468943
- Role:
Other
- Salary:
Not Disclosed by Recruiter
- Industry:
Clinical Research / Contract Research
- Department:
Other
- Role Category:
Other
- Employment Type:
Full Time, Permanent
- Key Skills
Clinical Research
Clinical
Clinical Data
Skills highlighted with ‘‘ are preferred keyskills
- Education
- UG:
MBBS in Any Specialization
Company Profile
- Rusan Pharma
- Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 €“ 150 Crs.
Contact Company:
Rusan Pharma
Address:
58-D,GOVT INDUSTRIAL ESTATE, MUMBAI, Maharashtra, India
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