Chengalpattu, Tamil Nadu, India
Experienced in Clinical Research and pharmacovigilance, I wish to utilize my skills and abilities in impacting the success and growth of a clinical research group in becoming and sustaining its reputation as a leader in the clinical research industry.
• Completion of Case Report Form (paper, web based and electronic CRF) and Resolution of Data Clarification Form (DCF), Maintaining Site Master File. • Preparation of the protocol, informed consent form and study data reports under the guidance of investigators • Submission of necessary documents to the Institutional Ethics Committee (IEC), SAE reporting to the sponsor and IEC. • Coordinating with the investigators during the subject’s visit, coordinating with the CRA during site initiation, site monitoring and site close-out visits. • Storage of Investigational Product, Dispensing of Investigational Product and patient counseling, Investigational Product Accountability.