Summary
Overview
Work History
Education
Skills
Additional Information
PROTOCOL THERAPEUTIC EXPERIENCE
Timeline
Generic

Shilpa Jayaraj

Summary

Focused and results-driven CRA with over 4 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.

Overview

9
9
years of professional experience

Work History

Clinical Research Associate II

BeiGene
Sydney, NSW
09.2022 - Current
  • Currently monitoring hematology and oncology studies in Phase I,II and III across multiple sites.
  • Monitored and co-monitored other CRAs to support CRA team.
  • Sound experience in conducting PSVs, SIVs, RMVs, and COVs per study requirements.
  • Conducted regular site visits to ensure protocol adherence, proper documentation, and accurate data reporting.
  • Enhanced patient care by closely monitoring and reporting adverse events in oncology clinical trials
  • All data sweep and interim analysis timelines are met.
  • Managed multiple clinical trial projects simultaneously, maintaining strict deadlines and budget requirements.
  • Identify site issues and initiates correction plans based on monitoring reports.
  • Perform investigative site file reconciliation: requests any new and updated site-related essential and non essential documents and review them for content, consistency with other documents, and compliance with
    appropriate local regulatory requirements, ICH GCP guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.
  • Verify data in source documents are in agreement with source, initiate data query resolution and
    confirm resolution in timely manner.
  • Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.
  • Verify drug accountability logs and storage requirements
  • Provided comprehensive training to site staff on study procedures, enhancing overall efficiency during trials.
  • Facilitated timely resolution of queries from regulatory authorities, contributing to smooth progress of clinical trials.
  • Continuously updated internal databases with patient data collected from participating sites, ensuring accurate and up-to-date information.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.
  • Generated reports for site and project management using CTMS.
  • Responsible for reviewing and tracking of study essential documents (e.g., IRB approvals, 1572s, CVs, investigator licenses and board certifications, lab certifications and normal ranges, etc) to ensure completeness and accuracy
  • Trained the investigator and staff regarding Study protocol and conduct via presentations, informational handouts and group discussions, identified any study related issue and suggested corrective measures if any or escalated the issue to the Manager as needed.
  • Provided timely and accurate submission of time reports, expense reports, monitoring reports, and schedules.
  • Documented all findings and activities at the site and complete a monitoring visit report and submit to the Manager.

Clinical Research Associate II

ICON, Formerly PRA, Providing Services For Bayer
Sydney, NSW
12.2020 - 09.2022
  • Monitored 4 protocols with varying indications at 10 sites across the country to ensure adherence to protocol and compliance with ICH guidelines, GCPs and FDA regulations
  • Primary monitoring activities included performing SIVs, and off-site monitoring visits during the pandemic. Remote and on-site SDV/SDR was performed for sites.
  • Conducted study start-up activities that included feasibility, site evaluation visits, compiling site documents for activation and prepared EC and RA documents required for approval.
  • Assisted Study project manager to produce site-specific contracts from the master template and submits the proposed contract and budget to the site.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance, and data quality.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Supported development and delivery of department training to maximize success of clinical research.
  • Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Submitted routine monitoring reports and follow-up letters to facilitate internal and external communication.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.

Clinical Research Associate I

ICON, Formerly PRA, Providing Services For Bayer
Sydney, NSW
08.2018 - 11.2020
  • Monitored data for pivotal Phase III studies for Endocrinology and Cardiovascular studies.
  • Functioned as the primary point of contact between sponsor and 8-10 study sites around the country.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits
  • Served as observation visit leaders for In-house CRAs.
  • Collected, reviewed and maintained regulatory documents and performed IRB submissions
  • Assisted in the development of protocols, case report forms, informed consent forms, and IRB materials
  • Monitored data expeditiously to reduce data discrepancies; collaborated with both the sites and data
  • Assisted site meet deadlines for the ongoing database lock occurring every 3 months.
  • Provided timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and Ethics committee.
  • Facilitated escalation processes for elevating site or study issues in clinical monitoring with monitored reports for study site personnel and team members
  • Coordinated study evaluation meetings and project meetings providing team with updates of each site activity.

Clinical Trials Assistant

ICON, Formerly PRA, Providing Services For Bayer
Sydney, NSW
10.2016 - 07.2018


  • Collected and reviewed regulatory documents from clinical sites
  • Initiated, maintained, and reconciled Trial Master Files
  • Organized and maintained tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Maintained accurate tracking and reporting of study metrics
  • Coordinated communication of tracking information between Clinical Operations and vendors
  • Planned & facilitated Investigator meetings for over 200 individuals including coordination of international travel, hotel, audio/visual needs, meals, transportation, registration & other necessary details
  • Follow up with sites for trial invoices and ensure CTMS is accurately updated to allow the timely processing of Investigator Payments
  • Assisted with Oncology site feasibility and site selection activities.
  • Assisted project manager to meet global deadlines with bladder study feasibility by liaising with Investigators and global study team throughout the feasibility period.
  • Completed HREA form for Oncology study and assisted with submission and all study start up activities
  • Responsible for ensuring monitor completes project related activities and redesigned filing structures
  • Performed Investigator Site File review, Source Data Verification and Drug Accountability during co monitoring visit
  • Corresponded regularly with global sites & investigators on trial details, submissions & approvals


Clinical Administrator

Chris O'Brien Lifehouse
Camperdown, NSW
05.2015 - 08.2016
  • Worked efficiently with cancer patients in all fields (Haemotology, Sarcoma, Gynaeoncology, Urology and Breast Oncology by providing high level of patient care and compassion when needed
  • Assembled charts for new patients, confirming inclusion of requested medical history and diagnostic information.
  • Assisted patients in adhering to prescribed care models via phone and email communications.
  • Managed patient scheduling and rescheduling, directing related billing issues to supervisor.
  • Arranged transportation for patients, coordinating transit times with appointment scheduling.
  • Verified and reconciled service charges with insurance companies and payment providers.
  • Ensured the availability of chemotherapy treatment information to patients by filing, retrieving, updating patient records, while protecting patients' rights
  • Demonstrated strong experience as an acting team leader by managing a team of 20.
  • Discussed medical histories with patients in effort to provide most effective medical advice.

Education

Bachelor of Medical Science (Anatomy & Physiology)

Western Sydney University
Sydney, NSW
02.2018

Skills

  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Strong attention to detail
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Strong customer focus
  • Proven flexibility and adaptability
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

Additional Information

Provided upon request

PROTOCOL THERAPEUTIC EXPERIENCE

Cardiology

Endocrinology

Oncology

Hematology

Timeline

Clinical Research Associate II

BeiGene
09.2022 - Current

Clinical Research Associate II

ICON, Formerly PRA, Providing Services For Bayer
12.2020 - 09.2022

Clinical Research Associate I

ICON, Formerly PRA, Providing Services For Bayer
08.2018 - 11.2020

Clinical Trials Assistant

ICON, Formerly PRA, Providing Services For Bayer
10.2016 - 07.2018

Clinical Administrator

Chris O'Brien Lifehouse
05.2015 - 08.2016

Bachelor of Medical Science (Anatomy & Physiology)

Western Sydney University

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Shilpa Jayaraj