Ankita Lakhekar
Melbourne
Summary
With 5 years of experience as a clinical research associate at a CRO, I have a strong background in biotechnology. Prior to that, I worked for 2 years as a medical scientist, medical assistant, and research intern at hospitals and research institutes. Taking a career break for maternity leave from September 2023 to July 2024 provided me with a unique life experience that has added to my life skills. Throughout my career, I have gained expertise in various therapeutic areas including cardiovascular diseases, neurology, immunology, dermatology, ophthalmology, and oncology from clinical monitoring. Additionally, my experience as a medical scientist has allowed me to delve into respiratory and sleep disorders. These diverse experiences have made me an integral part of the biopharmaceutical industry, which is focused on shortening the distance from lab to life. In addition to my extensive industry knowledge, I possess versatile skills in project management, problem-solving, and collaboration. I am known for bringing a fresh perspective and demonstrating a strong commitment to quality and success. My adaptability and proactive approach have been recognized in delivering effective solutions.
Overview
10
10
years of professional experience
Work History
Sr CRA I
Syneos Health
10.2022 - 09.2024
- Responsible for monitoring all types/phases of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility for site management and performance, including documentation
- Mentored and trained junior-level CRAs
- Responsible for collaboration with Central Monitors assigned to clinical research projects for which in-house centralized monitoring activities occur
- Participated in Business Development client presentations and bid defenses as requested.
CRA II
Syneos
02.2021 - 09.2022
- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, all in-house and on-site monitoring for all visit types including documentation
- Skilled at working independently and collaboratively in a team environment.
CRA
Medpace
06.2019 - 01.2021
- Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Medical device and/or investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
Medical Scientist
Cabrini Hospital
03.2018 - 06.2019
- Diagnosed patients for sleep disorders, such as Sleep Apnea, by conducting polysomnography on patients, including setting up patients for electrocardiogram (ECG), electroencephalogram (EEG), electromyography (EMG), and electrooculography (EOG), amongst other signals followed by monitoring the clinical data using a sleep lab titration system
- Conducted pulmonary lung function test, spirometry, gas transfer, and other tests to diagnose lung disorders in patients with respiratory disorders symptoms.
- Participated in cross-functional teams tasked with evaluating new technologies or methodologies for potential adoption, ensuring alignment with organizational objectives.
Medical Assistant
Knox Private Hospital
01.2018 - 04.2018
- Provided general administration support to the Respiratory Clinic using strong computer skills involving Microsoft Office
- Liaised with clinical trial staff, such as Principal Investigators, Study Coordinators, and nurses to learn about clinical trial designs
Duty Manager
Woolworths
02.2015 - 03.2018
- Supervise store trade while on duty and manage time and resources efficiently to provide quality service in store
- Manage technical and customer issues while adhering to the brand policies
Research Intern
Murdoch Children's Research Institute
03.2016 - 06.2016
- Worked on Children's Attention Project (NICAP) to collect information from the study conducted and helped in keeping records and documents updated as the project advanced
- Used different statistical software such as FreeSurfer to edit and Analyze brain MRI scans for more reliable results and compiled the information in order to study ADHD (Attention Deficit Hyperactivity Disorder)
- Collaborated with team members for successful completion of research projects on time and within budget.
Education
Masters - Biotechnology
University of Melbourne
12.2015
Bachelor - Engineering
P.I.E.T
12.2012
Diploma of Industrial Biotechnology - Biotechnology
Mitcon Institute
Pune02-2014
Skills
- Friendly, Positive Attitude
- Teamwork and Collaboration
- Customer Service
- Problem-Solving
- Time Management
- Attention to Detail
- Critical Thinking
- Active Listening
- Problem Resolution
- Organization and Time Management
Therapeuticexperience
Coronary Syndrome, Acute, Narcolepsy, Rare Disease, Restless Legs Syndrome, Cancer, Follicular Lymphoma, Respiratory Disorders
Languages
Hindi
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Punjabi
Advanced (C1)
German
Elementary (A2)
Timeline
Sr CRA I
Syneos Health
10.2022 - 09.2024
CRA II
Syneos
02.2021 - 09.2022
CRA
Medpace
06.2019 - 01.2021
Medical Scientist
Cabrini Hospital
03.2018 - 06.2019
Medical Assistant
Knox Private Hospital
01.2018 - 04.2018
Research Intern
Murdoch Children's Research Institute
03.2016 - 06.2016
Duty Manager
Woolworths
02.2015 - 03.2018
Bachelor - Engineering
P.I.E.T
Masters - Biotechnology
University of Melbourne
Diploma of Industrial Biotechnology - Biotechnology
Mitcon Institute
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