Carrie Ann Talasila
Rockaway,New Jersey
Summary
Accomplished Clinical Research Officer with 5 years of experience performing Sponsor related trial obligations. Well -versed in pre-study site evaluations, regulatory document collection and study specific requirements. Diligent in performing studies aligned with good clinical practices, protocol requirements and sponsor standard operating procedures . Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
9
9
years of professional experience
Work History
Sr. Clinical Research Officer
Glenmark Pharmaceuticals
07.2012 - 11.2012
- Created the Derma Master Chart that allowed for careful Sponsor oversight of all aspects of the clinical trial.
- Conducted Principal Investigator meetings and training sessions as Sponsor Representative to conduct protocol review-adherence and ensure GCP compliance (Good Clinical Practice) as well as Sponsor SOP compliance (Standard Operating Procedures).
- Maintained strict adherence to GCP and GMP(Good Manufacturing Practices) regulations and guidelines, minimizing risk to protocol deviations.
- Effectively conducted Ethics Committee Review meeting and IRB (Institutional Review Board) Submissions to obtain trial Approvals.
- Maintained continuous reporting to the Ethics Committee on occurrence of any trial related Adverse Drug Reactions (ADR) or any protocol deviations.
- Enhanced communication between the Indian based Sponsor team and US based Investigator sites members by organizing regular meetings and fostering open dialogue.
- Analyzed and reduced potential trial risks by proactively identifying potential issues and implementing appropriate contingency plans so as to ensure smooth completion of the trial within the specified timeline.
- Managed budgets effectively, prioritizing resource allocation among all Investigator sites for maximum patient recruitment and safety adherence.
- Spearheaded successful Derma Clinical Trials from conception through completion, showcasing strong project management abilities.
- Conducted GCP training for all new Interns.
Clinical Research Officer
Glenmark Pharmaceuticals
04.2008 - 07.2012
Clinical Research Associate
Glenmark Pharmaceuticals
02.2007 - 04.2008
Management Trainee
Eureka Forbes
05.2004 - 05.2005
- Trained in Brand Culturisation
- Expansion of company's customer data base
- Preparation and monitoring of annual budgets
- Post Event reporting structure. System recommendations and analysis.
Education
Post Graduate Diploma - Clinical Research
Cranfield University, UK / ICRI
Mumbai, India06.2010
Post Graduate Diploma -Pharma Business Management - Clinical Research
Institute of Clinical Research (India)
Mumbai, India06.2007
Bachelor of Science - Chemistry
St. Xavier's College, Mumbai University
04.2004
Skills
- Strong Interpersonal Communication Skills
- Effective Work Coordination
- Strategic Planning and Task Prioritization
- Reliability
- Time Management Abilities
- Teamwork and Collaboration
Hobbies
In my free time I enjoy studying Muay Thai which is a form of Martial Arts.
Timeline
Sr. Clinical Research Officer
Glenmark Pharmaceuticals
07.2012 - 11.2012
Clinical Research Officer
Glenmark Pharmaceuticals
04.2008 - 07.2012
Clinical Research Associate
Glenmark Pharmaceuticals
02.2007 - 04.2008
Management Trainee
Eureka Forbes
05.2004 - 05.2005
Post Graduate Diploma - Clinical Research
Cranfield University, UK / ICRI
Post Graduate Diploma -Pharma Business Management - Clinical Research
Institute of Clinical Research (India)
Bachelor of Science - Chemistry
St. Xavier's College, Mumbai University
Similar Profiles
Nagaraj GowdaNagaraj Gowda
Vice President, Drug Discovery Research and Development at Ichnos Glenmark Innovation (IGI), Glenmark Pharmaceuticals Ltd.Vice President, Drug Discovery Research and Development at Ichnos Glenmark Innovation (IGI), Glenmark Pharmaceuticals Ltd.
MUKESH SRIVASTAVAMUKESH SRIVASTAVA
Zonal Sales Manager at Glenmark PharmaceuticalsZonal Sales Manager at Glenmark Pharmaceuticals
SANDEEP ACHARYASANDEEP ACHARYA
District Sales Manager at Glenmark PharmaceuticalsDistrict Sales Manager at Glenmark Pharmaceuticals
Karthik T. SKarthik T. S
Field Sales Officer at GLENMARK PHARMACEUTICALS LTDField Sales Officer at GLENMARK PHARMACEUTICALS LTD
Brianne MullerBrianne Muller
Assistant Teacher at Lightbridge AcademyAssistant Teacher at Lightbridge Academy