Clinical Research Associate, Monitoring
Resume:
Sandeep
: +91-880*******, +919*********
: ***********@*****.***
Career Objective:
To work in clinical research industry to utilize my interpersonal skills, ideas and abilities that offer professional growth while being resourceful, innovative and flexible as an asset for growth of company, I am working with.
1. The Larvol Group (Nov 2011 – Dec 2012)
Market Intelligence Analyst
Job Profile:
Analyze, monitor, and track pharmaceutical R&D.
Worked on expansion, updation and maintenance of most comprehensive source of ongoing clinical trial intelligence (Larvol Insite).
Identification of all drugs being developed by the pharmaceutical companies in their drug development pipeline.
Preparation of Market Intelligence Reports.
2. Tech-Observer India Pvt. Ltd. (Aug 2010 ¬¬– Feb 2012):
Phase III, randomized, two arm, open label, active controlled, multi-centric clinical study to evaluate the efficacy and safety of a topical solution of investigational product in comparison with standard therapy in acute painful Musculoskeletal conditions.
Phase III, randomized, two arm, open label, active controlled, multi-centric clinical study to evaluate the efficacy and safety of a topical solution of investigational product in comparison with standard therapy in acute low back-ache.
Post Marketing Observational Study (PMOS) of Duphaston in females with irregular menstruation.
Post Marketing surveillance to study prevalence of type-2 diabetes in Indian subjects with renal dysfunction.
Job Description:
Assisting and development of Standard Operating Procedures (SOPs).
Work to ensure the overall success of the designated Clinical operations/monitoring projects.
Identifying and initial budget discussion, recruiting investigators.
Conduct on-site clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP guidelines, and Tech Observer/sponsor’s SOPs.
Perform on-site visits, including site qualification, initiation, monitoring and closeout visits.
Assisting in investigator meeting including logistics, liaison, presentations, problem resolutions, and follow up.
Ensure timely submission of protocol / informed consent documents for EC/IRB approval.
Maintain all study files and documentation pertaining to studies a per Service Legal Agreement & Project specifications.
Training & motivate investigators in order to achieve recruitment targets.
Maintaining regular contact with study sites to ensure protocol/GCP compliance.
Communicate progress of study and relevant information to Project Manager/Sr. CRA and other project team members.
Complete accurate study status reports in time.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with Protocol/& SOPs.
Deal with CRF queries in a timely manner.
Assisting in and drafting of study related documentation, e.g. draft protocols, draft CRFs, ICDs and monitoring guidelines.
Ensure correct archiving of study files on completion of a clinical study.
Vendor management activities
IP storage and inventory management at the Tech Observer authorized premises and at the investigator site.
Providing support in effective and compliant Adverse Event Reporting system.
Other responsibilities as delegated by the management representative.
Technical Skills:
Operating Systems: Windows XP Professional, Windows 7
Packages Known: MS Office (Word, Outlook, PowerPoint, Excel)
Oracle clinical (RDC 4.6)
Internet Knowledge: Well aware with various search engines (pubmed, CT.gov, CTRI)
Professional Qualification:
B. Pharma (Bachelor of Pharmacy) from PDM College affiliated to MD University, Rohtak, June 2010
Personal Vitae:
Name Sandeep
Sex Male
Date of Birth 6th May 1986
Marital Status Single
Present Address F- 41 Katwari Sarai, South Delhi.
Languages Spoken English, Hindi
Date: (Sandeep Vats)
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