Experience

ClinForce

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Patient Informed Consent Specialist (Project Manager)

  • May 2008 - Present

  Gained great experience in authoring, reviewing, and negotiating generic informed consents for clinical trials ( a generic consent, a genetic consent, and a HIPAA authorization for all central/local IRBs). •Responsible for reviewing, and negotiating informed consents with central and local IRBs in the US and providing generic consents. •Interfacing with team regarding substantive changes to defined ICF sections. •Performing ongoing template negotiations for established informed consent templates. •Ensuring timely review and tracking of consents to meet established study timeline and required metrics.



Icon Clinical Research

• India
• Hospitals and Health Care
• 100 - 200 Employee

• CLinical Studies Associate 2

  • Jan 2008 - May 2008

  Gained great experience and knowledge working with Sponsors and Investigative sites to collect and ensure regulatory documents meet the required specifications. Also gained great knowledge in ICDA review by becoming a member of the group. •Responsible for primary contact with investigative sites and monitors during the site start-up phase. •Responsible for reviewing various ICD’s as a part of be in the ICDA revisions group. •Responsible for maintenance of site address and personnel information in the various systems used for the study database as well as maintenance of regulatory documents throughout the duration of the clinical trail.



Covance

• United States
• Research Services
• 700 & Above Employee

• Site Activation Associate

  • Mar 2007 - Dec 2007

  Offered great experience in working with investigative sites to collect the required investigator and regulatory documents for a study and ensured that the documents met the specifications required by local regulations. •Responsible for primary contact with investigative sites during site start-up activities. •Responsible for working with investigative sites to negotiate and finalize investigator contracts and budgets •Responsible for maintenance of site address and personnel information in the Trial Tracker Site Information Module study database as well as maintenance of regulatory documents throughout the duration of the clinical trail.