Experience

PAREXEL INTERNATIONAL CLINICAL RESEARCH PRIVATE LIMITED
• India
• 100 - 200 Employee
• Clinical Operations Lead

  • Jan 2019 - Present

Currently Available for new Opportunities
• IT Services and IT Consulting
• 100 - 200 Employee
• Project Manager

  • Nov 2018 - Present

Syneos Health (Previously INC Research/inVentiv Health)
• Project Manager

  • Aug 2018 - Present


Duke Clinical Research Institute

• United States
• Research Services
• 700 & Above Employee

• Project Leader

  • Jun 2017 - Present

  I have joined Duke Clinical Research Institute as Project Leader. I have joined Duke Clinical Research Institute as Project Leader.


INC Research
• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Clinical Team Lead

  • Jul 2012 - Jul 2014

Genzyme
• 1 - 100 Employee
• Clinical Project Manager

  • Apr 2008 - Jun 2012


Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. CRA

  • May 2005 - Apr 2008

  Responsible for management of clinical trials at assigned sites. This includes conducting site selection visits, assisting the sites in developing recruitment plans, site initiation visits, routine monitoring visits and close-out visits using FDA/corporate guidelines. During monitoring visits, responsibilities include ensuring proper completion and submission of site regulatory documents, verification of site adherence to FDA/ICH regulations and guidelines, source document verification, verification of drug accountability, return of clinical supplies, ongoing training and support of site personnel, and preparation of site visit reports. Monitoring experience has included use of paper and electronic CRFs. Show less



Kforce/Merck Alliance

• Sr. CRA

  • Jun 2004 - May 2005

  Responsible for management of clinical trials at assigned sites. This includes conducting site selection visits, assisting the sites in developing recruitment plans, site initiation visits, routine monitoring visits and close-out visits using FDA/corporate guidelines. During monitoring visits, responsibilities include ensuring proper completion and submission of site regulatory documents, verification of site adherence to FDA/ICH regulations and guidelines, source document verification, verification of drug accountability, return of clinical supplies, ongoing training and support of site personnel, and preparation of site visit reports. Monitoring experience has included use of paper and electronic CRFs. Show less



MDS Pharma Services

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Sr. CRA

  • Jul 2000 - Jun 2004

  Responsible for management of clinical trials at assigned sites. This includes conducting site selection visits, assisting the sites in developing recruitment plans, site initiation visits, routine monitoring visits and close-out visits using FDA/corporate guidelines. During monitoring visits, responsibilities include ensuring proper completion and submission of site regulatory documents, verification of site adherence to FDA/ICH regulations and guidelines, source document verification, verification of drug accountability, return of clinical supplies, ongoing training and support of site personnel, and preparation of site visit reports. Served as lead CRA on three studies. Show less



UTHSCSA

• United States
• Hospitals and Health Care

• Research Manager/Study Coordinator

  • Oct 1990 - Jul 2000

  Research manager Managed inpatient and outpatient research sites. Responsibilities included supervision research coordinators and research assistants; training for new staff, students and residents assigned to clinical studies; preparation of IRB submissions, protocol amendments/revisions, annual reviews; maintenance of all regulatory files; preparation and negotiation of study budgets; liaison with study sponsors and referral sources; preparation of study-specific computer databases, flow sheets, and study orders; acted as resource person for coordinators, nursing staff, medical staff and students for regulatory and study information, identified problems in the site research processes then implemented corrective actions; and developed site research SOPs. Additional responsibilities included performance of behavioral and movement disorder assessments; preparation of lab samples for shipment; providing presentations on research and psychiatric topics to health care professionals, lay groups, and patient/family support groups. Clinical Research Coordinator Responsibilities included management of all phases of inpatient investigational drug studies including maintenance of regulatory documents; initial IRB submission and continuing IRB correspondence; training research staff; liaison with study sponsors; completion of CRFs; maintenance of source documents; maintenance of drug accountability records; and preparation for monitoring visits. Additional responsibilities included performance of behavioral and movement disorder assessments; subject recruitment and screening; and preparation of lab samples for shipment. Show less