Objectives

My career goal is to leverage my skills and expertise to contribute to the growth and success of a company. I am passionate about using my abilities to make a positive impact and to help organizations achieve their objectives. By continuously learning and developing new skills, I aim to take on challenging roles that allow me to grow both professionally and personally, while making meaningful contributions to the company's success. I am committed to working collaboratively with my colleagues, sharing my knowledge and ideas, and staying up-to-date with industry trends and best practices. Ultimately, my goal is to build a fulfilling and rewarding career that aligns with my values and enables me to make a difference in the world.

Experience

Quintiles, Bangalore, India

Dec 2014 – June 2015

As a clinical operations assistant, I performed a range of tasks that supported the efficient and effective execution of clinical trials. Specifically, my responsibilities included:

Collaborating with clinical analysts to update and maintain clinical systems that track site compliance and performance, ensuring that all activities are completed within project timelines.

Supporting the clinical team in the preparation, handling, distribution, and filing of clinical documentation and reports, in accordance with the scope of work and standard operating procedures.

Applying my hands-on experience in CTMS and EDC (InForm) to support the management of study files and assisting with periodic reviews to ensure completeness.

Assisting clinical analysts with the preparation, handling, and distribution of clinical trial supplies, and maintaining tracking information to ensure timely delivery and accurate inventory management.

Serving as a central point of contact for the clinical team regarding designated project communications, correspondence, and associated documentation.

Providing administrative support as needed to facilitate clinical trial execution within the centralized clinical operations model.

Through my contributions, I aim to help ensure the successful completion of clinical trials, and to support the development of safe and effective treatments that can improve patient outcomes.

Clinical Research Coordinator, Site Observer, Bangalore, India

May 2014 – Nov 2014

As a clinical research coordinator, my role involves working closely with site monitors and study teams to facilitate the smooth execution of clinical trials. Specifically, my responsibilities include:

Coordinating with site monitors during site selection, initiation, routine monitoring visits, and site closeout visit activities to ensure that all study activities are conducted in accordance with the protocol and applicable regulations.

Developing, implementing, and maintaining study documents, timelines, files, communication tools, and systems used in conducting a project, ensuring that all study-related information is accurately recorded and accessible to the study team.

Maintaining study-related logs and forms, including screening, enrollment, drug accountability, temperature, and other communication logs, to provide an accurate record of study activities.

Following up with the study team for timely completion of source documents and ensuring that all relevant information required in the CRF is present in the source document.

Assisting the investigating team in the process of administering informed consent to subjects and explaining in detail the patient information sheet and patient diaries.

Coordinating screening and recruitment of patients based on protocol eligibility criteria, and coordinating all patient-related appointments to ensure timely completion of study activities.

Maintaining subject-related source documents such as visit notes, medical history, laboratory investigations, ECG reports, and other documents as required in the protocol.

Ensuring proper follow-up until proper resolution of study-related issues and performing data entry into EDC within timelines specified by the sponsor.

Maintaining the temperature range of investigational product as per protocol, performing study drug accountability for each subject, and managing study materials and investigational product by ordering, tracking, storing, dispensing, reconciling, and destroying.

Coordinating all lab-related activities between local/central laboratory and courier for shipment of samples and updating and maintaining the investigator site file and sending progress reports to CRO.

Managing EC-related study documents submissions and notifying all AE’s and SAE’s and other applicable regulatory requirements within the timelines, and immediately reporting any serious adverse events (SAE’s) to the PI and the sponsor, IRB, and other regulatory requirements.

Through my contributions, I aim to ensure that clinical trials are conducted in a safe and efficient manner, and that study data is accurately collected and recorded to support the development of new treatments that can benefit patients.

Accenture, Bangalore, India - Associate of Clinical data management team (Indian Clinical research Center)

April 2009 to Feb 2010

As a study timeline associate, my responsibilities include:

Acquire comprehensive knowledge of data entry guidelines and processes.

Centralize and prioritize quality issues in collaboration with the SQA team.

Provide guidance and advice to the SQA team on issue resolution processes.

Ensure prompt and effective resolution of all issues.

Monitor and report on database quality and implement performance tests to identify and address performance bottlenecks.

Escalate critical issues to the client for resolution, when higher level intervention is needed.

Maintain a knowledge database to identify and address recurring issues.

Evaluate current procedures and propose improvements to enhance speed and accuracy.

Undertake any other relevant duties as required by the client.

Research Analyst at EmPower Research (unit of Genpact)

Jan 2008 - April 2009

As a research analyst, my responsibilities include:

Conducting in-depth research on International Medical Practitioners by utilizing institutional libraries, archives, and other reliable sources of information to collect, record, analyze and evaluate facts.

Ensuring the accuracy and completeness of profiles created by Associates through meticulous quality checking.

Collaborating with the Business Development Department to support the company's own development projects.

Through these responsibilities, I am committed to delivering reliable and high-quality research that supports the company's objectives and growth.

Education

PG Diploma in Clinical Research and Data Management at Institute of Clinical Research (India) with major in Clinical research and Data Management [2008-2009]

MSc Biotechnology @ PESIT Bangalore – Bangalore University [2004-2006]

BSc Biotechnology @ BMS College for Women - Bangalore University [2001 – 2004]

Clinical Research Experience

Familiarizing myself with all data entry guidelines and processes

Centralizing and prioritizing quality issues for efficient resolution

Educating and advising the SQA team on issue resolution processes

Ensuring timely resolution of all issues to maintain smooth operations.

Monitoring and reporting on database quality and implementing performance tests to identify and address bottlenecks.

Escalating complex issues to clients for higher level intervention

Developing and maintaining a knowledge database to identify recurrent issues and improve efficiency.

Evaluating current procedures and proposing changes to improve speed and accuracy.

Performing any other duties as required by the client.

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