SARAVANAN BHOJARAJ
Limerick
Summary
Focused and quality driven Clinical Research Associate with 3 years of experience in Novo Nordisk. Having a thorough knowledge of ICH-GCP, NDCT rules 2019, regulatory clinical development process and GDP. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Novo Nordisk
India
12.2021 - 08.2023
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Proficient in conducting feasibilities, site initiation visits, site activation visits, onsite and offsite monitoring.
- Customizes Site Specific Subject Information and Informed Consent (SIIC) forms to local requirements based on local process until HA approval.
- Support PM with Source Data Agreement review as per the protocol.
- Reported to project manager for issues related to overall study status.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Provided training on GCP standards to new personnel or existing staff members.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Attended meetings and reported on activities and resolutions.
- Evaluated proof of eligibility and consent for participants.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Maintained strict confidentiality to keep personal information and collected data private.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Coordinated movement of laboratory samples by establishing and enforcing security and safety standards.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Provided support in writing informed consent forms, patient diaries, study manuals.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Coached team members on best practices for conducting effective studies.
- Working with site staffs closely to ensure that focus on quality is continued.
Clinical Trial Administrator
Novo Nordisk
India
12.2020 - 11.2021
- CTRI registration for the new trials and update of all the ongoing trials - INDIA.
- Managing COUPA - uploading contracts and confidentiality agreements; getting the COUPA ID for invoice processing/as per the requirement for payment processing.
- Archiving documents in electronic Trial Master File (eTMF) system for the ongoing projects.
- Processing all the trial-related payments on time e.g., investigator payment, EC payment, vendor payments etc.
- Communicating with the courier agencies like DHL, TNT, Marken and FedEx and providing the required documents for the Indian custom authorities to clear shipments through Customs.
- Ensuring collection and review of Green Light Documents as per the NN SOPs.
- Set-up/maintenance of Sponsor Trial Master File (STMF) tasks (Country and Site- specific documents).
- Assist in preparation of initial Investigator Trial Master Files (ITMFs)
- Supporting CRAs in distribution of trial document to trial sites (timely distribution of investigator trial master file documents) ex: printing and shipment of latest approved informed consent to the sites
- Provided general administrative support to staff members.
- Maintained filing system for important documents such as contracts and invoices.
- Checked office stock to determine supply levels and maintain inventory.
- Managed office supplies inventory and placed orders when necessary.
- Coordinated meetings, conferences, travel arrangements.
Education
M.Sc. - Process Validation and Regulatory Affairs
Technological University of Shannon
LimerickM. Pharm - Pharmacology
JSS College of Pharmacy
B. Pharm -
JSS College of Pharmacy
Skills
- Quick Learner
- Self-motivated
- Team worker
- Leadership
- Training
- Problem solving
- Data Analysis
- Issue Management
- Vendor (TPO) Negotiation
- Process Improvement
- Interactive Management
- Good Clinical Practice
- Team Training
- Project Management
- Site Management
- Organizational Skills
- Good communication skills
System Knowledge
- Momo App, Nnexus, Coupa, Veeva Vault-COSMOS/eTMF, CTRI, CONNECT, EDC, IWRS, HOT, IMPACT, ISITE, CALYX, MS Office
Affiliations
Trials worked as CRA: PIONEER PLUS, PIONEER TEENS.
Handled 10 sites.
During CTA, supported 6 studies for INDIA, MALAYSIA, THAILAND and SINGAPORE.
Accomplishments
Department of operational excellence:
- Super user for Momo App
- Mentored New CRAs on training in clinical system tools and monitoring SOPs.
- Core member of Public Relation and Communications Group in Clinical team at Novo Nordisk.
AWARDS and ACHIEVEMENTS AS CRA:
- Nominated as Best CRA Q1 and Q2 2022
- Well known for writing Monitoring visit report and TAT is less than 2 days.
- Appreciated by Principal Investigators for Quality of my work and the training I provide to the site staffs.
- High compliance in NN GCP Audit
AUDIT EXPERIENCE AS CRA:
I have faced two Good Clinical Practice Audit for the highest recruiting sites for the study PIONEER TEENS. I have been appreciated by the auditor for the quality of work done at site.
Result outcome: The site audits had no critical issues.
AWARDS and ACHIEVEMENTS AS CTA:
- Conferred with BEST CTA RISING STAR H1 2021.
- Conferred with CMRQ BEST RECOGNITION AWARD Q2 2021 for achieving FPFV for the new therapeutic area NASH and for the trial named ESSENCE.
ACADEMIC AWARDS:
- Conferred with Silver Medalist in Masters in Pharmacology.
- Conferred with Indian Drug Manufacturer’s Association award in B.Pharmacy
- Conferred with JSSCP GOLD MEDAL award in B.Pharmacy for the year 2014-2018.
- Conferred with Tablets India GOLD MEDAL award for Best Outstanding Student.
- Conferred with Harmonians 95-96 for the Best Out Going Student in B.Pharmacy
- Conferred with Carnival Medica Award for the Best Out Going Student in B.Pharmacy
- Been awarded as outstanding student in Communication skills at Inter College Competition.
Certification
- Pharmacist-PCI (India)
References
References available upon request.
Disclaimer
I declare that all the above said information is true up to my knowledge.
Timeline
Clinical Research Associate
Novo Nordisk
12.2021 - 08.2023
Clinical Trial Administrator
Novo Nordisk
12.2020 - 11.2021
M.Sc. - Process Validation and Regulatory Affairs
Technological University of Shannon
M. Pharm - Pharmacology
JSS College of Pharmacy
B. Pharm -
JSS College of Pharmacy
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