Roopa Patil

A clinical research professional utilizing skills gained through education and experience for an organisation that offers professional growth while being resourceful, innovative and flexible.

20800, Apt 493, Villages of Cupertino, Valley Green Dr.

+1-408-***-****

ac4ddo@r.postjobfree.com

EXPERIENCE

QuintilesIMS, India Lead Clinical Analyst

Feb 2014 - Apr 2017

-Was involved in constant monitoring of project specific key data points to ensure subject safety and data integrity.

-Handled the task of identification and analysis of project risk factors.

-Would recommend and follow up corrective/preventive actions based on data trend analysis.

-Led a team of 2-4 members.

-Was involved in internal process enhancement for centralised clinical operations.

-Was selected to pilot remote monitoring strategy for three global trials.

-Managed financials through handling Investigator payments, invoices and reconciliation.

-Ensured completeness of eTMF.

-Facilitated escalation processes for site issues.

-Reviewed monitoring reports

-Compiled and communicated study metric and summary reports to senior management.

-Supported CRAs in preparation for SMVs.

-Worked with regional managers to have 24/7 support for global trials.

Actavis Inc., India CRA 2

Aug 2010 - Feb 2014

-Acted as the primary contact between investigators and company representatives.

-Ensured adherence to protocols, SOPs and applicable regulatory through conduct of SMVs.

-Tracking, reporting and final reconciliation of SAEs and PDs.

-Provided regular updates to project managers and liaise with other team members when required.

Clinigene International Ltd, India CRA 2

Mar 2008 - July 2010

-Involvement in study start up activities including site selection, budget finalization, and initiation visits.

-Coordination of Investigator meetings.

-Responsible for study drug shipment and accountability.

-Coordinating with external vendors for study documents and supplies.

-Preparation of documentation for Ethics committee.

-Co-monitoring with senior CRAs.

-Secondary in-house monitoring.

-Coaching junior CRAs.

EDUCATION

Lotus Clinical Research Academy, Bangalore, India

Certificate course in Clinical Research

Nov 2007

Dr.M.V.Shetty College of Physiotherapy, Mangalore, India

MSc in Cardiorespiratory Physiotherapy

May 2005

KLE’s College of Physiotherapy, Belgaum, India

BSc in Physiotherapy

May 2001

Barnett Educational Services GCP exam.

SKILLS

Risk based Monitoring

Team management (2-4 members)

Data driven trial execution

Independent monitoring experience in phase 1-3 trials

Diabetes Mellitus, Rheumatoid Arthritis, Psoriasis, Osteoporosis, Oncology (NSCLC, Glioblastoma), Female fertility, Alzheimer's disease.

Experience with CTMS and web based EDC (Inform, Medidata Rave)

AWARDS

Received employee recognition awards for contribution in early database lock, reconciliation of PDs and timely support to CRAs.

LANGUAGES

English, Hindi.

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