Acting: Have an acting commission with Sakkath Studio in a local Kannadiga webseries
Mausumi Rabha
Clinical Research Professional
Gjovik
Summary
A dedicated professional with a background in clinical research and education, I've seamlessly navigated diverse roles with a commitment to ethical standards and regulatory compliance. From contributing to various clinical research projects to inspiring students as an MYP Science teacher, my journey has been dynamic and fulfilling. Now, drawn by a heartfelt desire to contribute to the field of clinical trials in India, I'm excited about the prospect of merging my research expertise and teaching finesse to make a meaningful impact in my homeland.
Overview
10
10
years of professional experience
5
5
years of post-secondary education
1
1
Certification
6
6
Languages
Work History
Maternity
Baby
07.2022 - Current
- Demonstrated strong organizational and time management skills while managing a baby while healing from a emergency C-section all by myself without any help from outside in a foreign country while dealing with postpartum depression.
- Resolved problems, improved operations and provided exceptional service.
- Proven ability to develop and implement creative solutions to complex problems.
Cover/Long-Term Substitute Teacher
Gjovikregionen International Skole
12.2021 - Current
- Classroom Management: Maintain order and discipline in the classroom.
- Lesson Delivery: Follow provided lesson plans and ensure learning continues seamlessly.
- Student Engagement: Foster a positive learning environment and engage students in the curriculum.
- Supervision: Oversee students during breaks, lunch, and other non-classroom activities.
- Communication: Report any issues or incidents to the regular teacher and school staff.
- Flexibility: Adapt to various grade levels and subjects as needed.
- Safety: Ensure the safety and well-being of students at all times.
- Professionalism: Represent the school and its values in a professional manner.
- Compliance: Follow school policies and procedures.
- Learning Support: Provide assistance to students as required.
IB MYP Science Teacher
Fuzhou Lakeside International School
07.2019 - 07.2021
Regulatory Document Reviewer III
Covance Clinical Development Services
05.2018 - 06.2019
- Document Reviewer III, Covance Clinical Development, Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial
- Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
- Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
- File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF
- Review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight
- Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines
- Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
- Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review
Research Associate III
Forte Research System Ltd (Advarra)
08.2017 - 04.2018
- Understand and interpret clinical trial study protocols in order to design and develop calendars for schedule of events
- Design and develop case report forms for clinical trial study protocols
- Develop a familiarity with Forte’s Clinical Trial Management
- Software (CTMS) and Electronic Data Capture (EDC) software in order to utilize related functionalities in the design and development of calendars and case report forms
- Work closely with reporting manager to complete daily/ weekly calendars and/or case report forms design in order to meet with pre-determined quality criteria
- Participate in customer interactions over the e-mail to assimilate customer requirements and address those adequately in the design and development of calendars and case report forms
- Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked
- Develop and update work ow documents that reflect latest updates to the features and functionalities of the CTMS and EDC, that are related to design and development of calendars and case report forms
- Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols
Remote Monitor
Quintiles Research Private Ltd, IQVIA
10.2014 - 05.2017
- Perform complex processes and tasks that eventually result in high quality deliverable that are completed according to service level agreements (SLAs) and within project timelines
- Have profound knowledge about the study protocol and Good Clinical Practices
- Establish and maintain effective project/ site communications Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Ensure Query aging and missing pages update within the speculated time.
- Create i-site packs for assigned sites and communicate to the respective CRAs.
- Maintain trends analysis for different triggers alerted on the infosario system.
- Assist Clinical Analysts with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assist the clinical team in the preparation, handling, distribution, and filing of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- May perform assigned administrative tasks to support team members with clinical trial execution within the Centralized Clinical Operations model.
Education
Master of Science - Biochemistry
Bangalore University
Bangalore 09.2011 - 08.2013
Bachelor of Science - Biochemistry
North Eastern Hill University
Shillong 08.2008 - 07.2011
Skills
Communication - Expert
Interpersonal skills - Expert
Teamwork - Expert
Adaptability - Expert
Acting - Expert
Time management - Expert
Leadership - Expert
Organization and Time Management
Training and Development
Certification
GCP
Interests
Timeline
Maternity
Baby
07.2022 - Current
Cover/Long-Term Substitute Teacher
Gjovikregionen International Skole
12.2021 - Current
IB MYP Science Teacher
Fuzhou Lakeside International School
07.2019 - 07.2021
Regulatory Document Reviewer III
Covance Clinical Development Services
05.2018 - 06.2019
GCP
03-2018
Research Associate III
Forte Research System Ltd (Advarra)
08.2017 - 04.2018
Remote Monitor
Quintiles Research Private Ltd, IQVIA
10.2014 - 05.2017
Master of Science - Biochemistry
Bangalore University
09.2011 - 08.2013
Bachelor of Science - Biochemistry
North Eastern Hill University
08.2008 - 07.2011
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