VP VISHAL PATEL
Gold Coast,QLD
Summary
Experienced highly skilled and accomplished Research Manager, experience in leading and overseeing research projects. Proven track record of successfully managing cross-functional teams, developing research strategies, and delivering high-quality results. Seeking a challenging position where skills can be utilized in research management to drive innovation and contribute to scientific advancement.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Research Manager
Tasman Oncology Research Pty
10.2021 - Current
- Led team of researchers in planning, executing, and managing trial projects in alignment with organizational goals and objectives
- Regular follow up with PI for EDC sign offs before data base lock, and during course of trial.
- Oversaw recruitment and training of research staff, ensuring acquisition of top talent and maintaining high-performing team
- Managed research budgets, allocated resources effectively, and optimized research operations to maximize productivity and cost-efficiency
- Maintained compliance with ethical guidelines and regulatory requirements throughout research process
- Developed and maintained Standard Operating Procedures (SOPs), and other documentation to ensure consistency and quality in research activities
- Successfully managed multiple Phase-I, II and Phase III clinical trials in accordance with protocol, GCP guidelines, and regulatory requirements
- Oversaw site selection, initiation, monitoring, and closeout activities, ensuring compliance with study protocols, SOPs, and regulatory guidelines
- Acted as primary point of contact for sponsor/CRO
- Assessed trial feasibility based on site’s capacity and resources, and completion of feasibility questionnaires after consultation with principal investigator
- Attended clinical governance meetings to discuss trial protocol for feasibility and other areas’ interest
- Communication with sponsor medical monitor, trial manager, CRA, Central lab and other vendors.
- Liaise with start up specialist for budget and contract negotiation
- Verified site’s readiness to recruit first patient after SIV and site activation
- Follow up with sponsor for overdue payments or awaiting proformas
- Perform budget amendment in case of new protocol amendment after careful review
- Frequent communication with multidisciplinary team, surgeons, specialists and radiation oncologists in regards to actively recruiting trial on site to help with trial recruitment
- Timely follow up with sponsor about slot allocations for phase-1 trials
- Trained nursing, pharmacy and other relevant staff before first patient enrolled for any new trial
- Conducted weekly investigator meetings with research staff and other sub-Investigators
- Attended Bi weekly management meetings and quarterly finance and quality meetings
- Regular implementation/improvement of quality guidelines to comply with ALOCAC+
- Record and final approval of patient visits in accounting software before invoice sent to sponsor for reimbursement
- Ensure to prevent confidentiality and privacy of patients while sharing source records and violation of ICH-GCP
- Review of site specific PICFs before approval at site level
- Lead on many Oncology and Rheumatology trials
Clinical Trial Coordinator, I/II/III
Tasman Oncology Research Pty Ltd
07.2020 - Current
- Conductance of phase-1 (FIH) to Phase III trials as a lead and back up.
- Attend Safety Review Committee meeting to evaluate DLT for dose escalation
- Attend weekly and bi weekly investigator meeting.
- Preparation of worksheets as per protocol, blank eCRFs and manuals before site is initiated.
- Liaising daily with patients on clinical trials
- Performing clinical procedures, including vital signs, and ECGs
- Performing laboratory processing of specimens
- Organizing patient appointments and procedures
- Ensuring informed consent is obtained and stored
- Preparation and maintenance of study documents for implementation of clinical trial
- Completion of data entry, data queries, & quality assurance checks
- Liaising with Clinical Research Associates, sponsor companies, and referring doctors
- Coordinating number of studies simultaneously
- Pro-actively providing ongoing information to management to ensure key milestones remain on-track
- Tracking and proactively following up on any Adverse Events
- Preparation and submission of regulatory documents for HREC
- Ensuring studies are conducted in accordance with regulatory and ethical guidelines as well as Standard Operating Procedures.
Clinical Research Associate
Sun Pharmaceutical Industries Ltd
03.2013 - 02.2018
- Conducted PSSV for site qualifications and feasibility assessment, SIV, IMV for protocol compliance and CoV throughout different stage of trial (i.e. start up to close out).
- Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) are accurate, current, and identical to Trial Master File (TMF)
- Provided timely reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB
- Conducted drug accountability visits, reviewed drug inventory and subject accountability records
- Inspected pharmacy area for study medication
- Facilitated escalation processes for elevating site or study issues in clinical monitoring with monitored reports for study site personnel and team members
- Ensured study documentation is completely and properly maintained in accordance with sponsor protocol, SOPs, GCPs, ICH Guidelines, and FDA regulations
- Preparation and submission of appropriate monitoring forms and site visit reports
- Monitored Investigator compliance for reporting of Adverse Events and Serious Adverse Events
- Ensure completeness of trial documents and reconciliation of same
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
Clinical Research Coordinator (BA
BE, Sun Pharmaceutical Industries Ltd
10.2010 - 03.2013
- Leader for allotted clinical research project
- Designing of research related documents like Case Report Forms and Research labels according to GDP, protocol, and regulatory guidelines
- Screening and recruitment of trial subjects
- Conductance of Bio Availability, Bio-Equivalence study of different therapeutic drugs & Phase-I clinical research studies as per ICH-GCP, Protocol, SOP and Regulatory requirements
- Ensure that clinical research activity is conducted in accordance with ICH-GCP, Protocol, and relevant regulatory
- Conductance of research activities such as Check-in, Alcohol Breath analyzing, Informed consent, investigational product administration and supervision
- Facilitate ALCOA collection of source data
- Preparation of Clinical Research Summary Reports (CSR) as per conducted clinical research data and protocol
- Monitoring of research subjects for Adverse Event (AE) and Serious Adverse Event (SAE) and documentation of same
- Communication with CRAs, Investigators, Ethics Committee (EC), Sponsor and DCGI regarding application, approvals, and AE/SAE of research subjects
- Blood sample collection, processing, storage, and shipment according to protocol
- Follow up call to study patient for further appointment regarding clinical information and in case of
- Adverse Event
- Protocol review and data entry of research data, resolving data queries and quality check
- Filing Protocol and SOP deviation, and Not to file
- Reconciliation of issued documents and archiving of same after completion.
Chemist
Bodal Chemicals Ltd
07.2010 - 10.2010
- Prepared specialized solutions to perform essential laboratory procedures
- Conducted routine raw material and sample testing
- Processed samples for chemical analyses
- Purchased chemicals and other supplies to meet needs of upcoming laboratory work
- Prepared rest solutions, compounds and reagents needed by laboratory personnel to complete tests
- Used chromatography, spectroscopy and other advanced techniques and machinery on regular basis.
Education
Masters - International Public Health
Griffith University
Brisbane, QLD11.2019
Master of Science - Chemistry
Madurai Kamaraj University of Baroda
Vadodara, Gujarat07.2012
Bachelor of Science - Chemistry
Maharaja Sayajirao University of Baroda
Vadodara, Gujarat07.2010
Skills
- Bio-availability, Bio-equivalence and Phase I/II/III Oncology
- Conductance and management
- ICH/GCP, Good Documentation Practice (GDP)
- Clinical site Monitoring
- Strong attention to detail
- Self-initiative
- Problem solving and convincing
- ALOCAC
- Quality Compliance
- People management
- Proven flexibility and adaptability
- Effective communication skills
Accomplishments
- Started Phase-1 trials on site as site was not experience with that before
- Started 7 new clinical trials in 9 months which is a record set by any manager
- Used Microsoft Excel to develop patient visit tracking with invoiceable procedures for better invoicing
- Introduced the software to download deidentified DICOM directly from the radiology server to make things easy for all.
- Introduced Good Documentation Practice and different SOPs on site
- Prevented confidentiality breach by refusing the request from sponsor due to conflict of interest
- Prevented a lot of protocol deviations by regular training
Certification
- ICH-GCP E6(R2)
- IATA
- iMedidata and Medidata RAVE
- REDCAP
- EDETEK
- Inform
- ALMAC
- Suvoda
- First Aid and CPR Training
- Blue Card Holder
- Mental Health First Aider
Languages
English
Full Professional
Hindi
Native or Bilingual
Gujarati
Native or Bilingual
Timeline
Clinical Research Manager
Tasman Oncology Research Pty
10.2021 - Current
Clinical Trial Coordinator, I/II/III
Tasman Oncology Research Pty Ltd
07.2020 - Current
Clinical Research Associate
Sun Pharmaceutical Industries Ltd
03.2013 - 02.2018
Clinical Research Coordinator (BA
BE, Sun Pharmaceutical Industries Ltd
10.2010 - 03.2013
Chemist
Bodal Chemicals Ltd
07.2010 - 10.2010
Masters - International Public Health
Griffith University
Master of Science - Chemistry
Madurai Kamaraj University of Baroda
Bachelor of Science - Chemistry
Maharaja Sayajirao University of Baroda
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