Highlights:

Skills:Expert in Clinical Research Operations

Site Operation Specialist 10/2014 - 05/2017
Govt Medical College Hospital, Chandigarh, Chandigarh India
Industry: Healthcare
Primarily responsible for enrolling the site targeted number of patients in study with good site data quality. Consistently achieved target for all projects. Ensured projects were completed within the established period of time.
• Submitting regulatory documents to IRB and Sponsor • Submitting the clinical study agreement to IH & PI for review • Attending investigator meeting(s) • Developing a preliminary budget and verify all costs • Helping PI negotiate the study budget direct costs with sponsor to cover all costs • Preparing for study initiation • Obtaining physician signatures • Recruiting subjects • Screening and scheduling subjects • Getting voluntary subject consent • Teaching subjects about protocol expectations for them • Performing study/protocol procedures in a detailed, accurate manner • Maintaining study files • Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work • Tracking subjects, avoiding lost-to-follow-up • Documenting an adverse event, including: o describing the event o severity and frequency o treatment o resolution • Processing and shipping lab work • Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including: IRB, Office of Sponsored Projects • Completing case report forms for PI review and approval • Maintaining study-specific supplies • Preparing for study closure and archiving--
Clinical Research Coordinator 05/2008 - 09/2014
Tagore Hospital Heart Care Centre, jalandhar, punjab India
Industry: Healthcare
Responsible to work closely with team at Investigational Site(s), provide them with necessary support, coordinate activities, implement best practices and provide oversight in order to ensure high quality data in Clinical Trials in accordance to Good Clinical Practice, regulatory requirements and company Standard Operating Procedures.
Job Responsibility includes: • Coordinate and/or review work at Site(s) in accordance with ICH GCP guidelines, applicable local regulatory and EC requirements, the contractual requirements and the approved study protocol and other study related documents. • Review Essential Documents including Investigational Product (IP) release documents for assigned site(s) for accuracy and completeness in line with applicable regulations and study specific client SOPs and/or requirements. • Assist in the tracking and reporting of enrolment metrics for assigned site(s). Provide necessary updates and reports related to enrolment to PM. • Assists various site visits i.e. pre-study, site initiation, interim monitoring visits and close-out visits. Ensure site readiness for these visits. • Review Investigational product (IP) and other study related supplies accountability at site(s). Identify and resolve potential issues. • Review Ethics Committee submission/approval/notification/correspondences for accuracy and completeness and adherence to GCP and other applicable regulations. • Ensure timely submission of study safety information i.e. SAEs, CIOMS, SUSARs, periodic safety reports etc to ethics committee and other authorities, as applicable. • Review study progress at assigned sites and contribute in preparation of status update reports in consultation with Project Manager. • Assist in the feasibility and site identification process and help in selecting best sites for participation in clinical studies. • Participate in various project related meetings/telecons. • Participate in audits/inspection. • Keep up-to-date with current legislation within Clinical Research and company Standard Operating Procedures. • Ad hoc administrative and miscellaneous job related duties as needed. • Update/maintain study specific trackers/worksheets.--

Lovely Institute of Paramedical Sciences 08/2009 - 08/2012
jalandhar, punjab, India
Degree: Bachelor's Degree
Major:Microbiology
Minor:Biochemistry
I have completed my Degree with part time JOB, so i have mention my work experience since 2008