Arpitha B R
Bangalore
Summary
To obtain a challenging position in the organization and to excel as a successful employee. Seeking continuous exposure to new ideas and stimulate personal and professional growth along with contributing for the growth of the company.
Overview
2
2
years of professional experience
Work History
Clinical Research coordinator
Leads Clinical Research and Bio services Ltd
08.2024 - Current
- Site selection, leading feasibility, ICF translations review and finalization, IRB & regulatory submission, Collection and QC Review of IRB/IEC/Regulatory Dossiers, Site initiation, Handling site level study activities, Subject recruitment, Study documentation and EDC, IP Management, AE & SAE management, conducting follow-up visits, leading project team, Conducting internal monitoring/supervisory visits, Conduction of study protocol trainings & GCP trainings, Study Close out, QC review.
- Knowledge on Tools used in CDM like, Medidata Rave, Octolsoft, Veeva vault, Ramos NG, Signant, Oracle.
- Conduct site/trial feasibility to identify select the right site and investigator for the study.
- Ensure timely compilation of all essential documents assisting regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals.
- Ensuring site setup according Coordinate for Clinical Trial Supplies receipt, accountability & storage.
- Assisting the process of administering the informed consent to the potential objects and discussing in detail the patient information sheet.
- Ensure that site documentation remains current, accurate and complete.
- Coordinate for lab samples collection and logistics; review of lab reports and update PI.
- Review & implement appropriate recruitment/referral activities for active enrolment at sites.
- Ensure CRF Completion and query resolution on specified timelines.
- Ensure that monitoring related findings are resolved within the timelines.
- Ensure patient follow up visit and visit compliance; manage patient related.
- Indication of Trial Phase of Trial Role in the Trial: Non-Small cell lung cancer (3 Studies) III CRC, Breast Cancer III CRC, Colorectal Cancer III CRC, Menopause Symptoms III CRC, Heavy Menstrual Bleeding Associated With Uterine Fibroids III CRC.
Education
Master of Science - Microbiology
Nrupatunga University
Bachelor of Science - CBBT
Government Science College
PUC - PCMB
RNS PU College
SSLC -
St Ann's Public high school
Skills
- Hard working, Optimistic, Deterministic nature aided with good leadership qualities
- Quick learner with minimal training
- Keen to learn new things & to apply them in day-to-day activities
- Good verbal and written communication skills, Time Management skills, Team work, Analytical, Problem-solving and Decision-making skills
- Ability to make significant contribution working In-groups and as well as individually
- MS Office
- Adobe Photoshop
- Clinical trial management
- Data collection methods
- Project coordination
- Team leadership
- Patient recruitment strategies
Languages
- Kannada
- English
- Kannada
Personal Information
- Date of Birth: 09/05/00
- Gender: Female
- Nationality: Indian
Hobbies and Interests
- Playing Badminton
- Listening to music
- Travelling
Projects
- Published review paper on 'Review on Antibiotic Resistance Bacteria', IJRASET Journal
- Evaluation of Probiotic attributes in coconut water, beetroot juice, wine, DEXTROSE TECNOLOGIES
Area Of Expertise
- Non-Small cell lung cancer, III, CRC
- Breast Cancer, III, CRC
- Colorectal Cancer, III, CRC
- Menopause Symptoms, III, CRC
- Heavy Menstrual Bleeding Associated With Uterine Fibroids, III, CRC
Areas Of Interest
- Core Clinical Operations: eTMF Specialist, Central Monitoring (CCRA), Remote Site Monitoring (RSM), Project Specialist, Study Start Up & Regulatory Associate (RSU), eTMF Reviewer
- Core Clinical Data Management: Clinical Data Associate, Clinical Data Coder, Clinical Data Analyst
Languages
English
Proficient
C2
Disclaimer
I hereby declare that the information given above is true to my knowledge.
Timeline
Clinical Research coordinator
Leads Clinical Research and Bio services Ltd
08.2024 - Current
Master of Science - Microbiology
Nrupatunga University
Bachelor of Science - CBBT
Government Science College
PUC - PCMB
RNS PU College
SSLC -
St Ann's Public high school