Ches Souru, BSN, MSc, CCRP
Toronto, Canada,ON
Summary
Dynamic clinical research professional with over 15 years of experience and a proven track record at St. Michael's Hospital, specializing in clinical trial management and participant recruitment. Demonstrated leadership and strong problem-solving skills, with a history of improving patient retention through innovative strategies. Highly skilled in event reporting and in building effective relationships with cross-functional teams to ensure regulatory compliance and successful project delivery. Brings strong operational, administrative, and communication skills across all levels of clinical research, with the ability to excel in both independent and team-oriented environments. Clinical research professional with substantial experience in managing clinical trials and ensuring regulatory compliance. Skilled in protocol development, data analysis, and patient safety oversight. Strong focus on team collaboration and achieving results through adaptive and reliable leadership. Known for effective problem-solving and strategic planning in fast-paced environments.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Clinical Research Manager
St Micheal's Hospital
Toronto, Canada
06.2021 - Current
- Managed clinical trial protocols ensuring compliance with regulatory standards.
- Coordinated cross-functional teams to streamline research processes and enhance collaboration.
- Developed training materials for new staff on clinical research methodologies and best practices.
- Oversaw participant enrollment strategies, improving retention rates through effective communication.
- Managed clinical trial protocols, ensuring compliance with regulatory standards.challenges proactively.
- Facilitated training sessions for study staff, enhancing their understanding of protocol requirements and procedures.
- Increased patient enrollment in clinical trials by developing targeted recruitment strategies and outreach programs.
- Managed 6 multi-site clinical studies, ensuring timely completion and compliance with regulatory standards.
- Established effective monitoring systems to track progress and identify potential issues in ongoing clinical trials.
- Trained colleagues in specialized software programs, increasing departmental productivity through optimized workflows.
Quality Assurance Associate
Pharma Medica Research Institute
Toronto, Canada
06.2020 - 06.2021
- Collaborated with development teams to resolve issues and implement quality improvements effectively.
- Conduct audits of Phase I and II clinical activities, including BA/BE studies, CRFs, and source documents, to ensure compliance with Good Clinical Practice (GCP), PMRI Corporate policies, departmental SOPs, and other relevant regulations and guidelines as appropriate; review protocols.
- Report findings to applicable departmental management: follow-up to ensure adequate completion of corrective actions.
- Ensure QA management is kept up to date regarding audit findings/corrective actions.
- Provide input and support as required to all PMRI divisions to ensure compliance with SOPs, GCP and other regulatory requirements.
- Final complete study documents review and archiving as per Health Canada policy.
Clinical Research Coordinator-II
Cliantha Research Inc
Mississauga, Canada
08.2019 - 06.2020
- Coordinated clinical trial activities to ensure compliance with regulatory guidelines.
- Managed patient recruitment and retention strategies to enhance study participation.
- Developed and maintained study documentation, ensuring accuracy and completeness.
- Assisted in data collection and analysis, contributing to research findings.
- Trained new staff on protocols and best practices in clinical research coordination.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Coordinated and monitored clinical trial activities to support the timely and accurate completion of studies.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Prepare and support QA Audits and sponsors' monitoring visits.
- Lab sample processing, labeling , storage, shipment, documentation and record keeping.
- IRBs' interaction and site regulatory documentation collection and management.
- Lab sample processing, labelling, storage, shipment, documentation and record keeping.
- Managed Phase1, Phase 2 and BA/BE studies
- Under the supervision of the manager, act as a study lead for research studies.
Senior Clinical Research Coordinator
King Khaled Eye Specialist Hospital
Riyadh, Saudi Arabia
01.2013 - 04.2019
- Coordinated clinical trial protocols and ensured compliance with regulatory requirements.
- Managed participant recruitment and retention strategies to enhance study engagement.
- Collaborated with cross-functional teams to streamline operational workflows and improve efficiency.
- Assisted in the preparation of scientific manuscripts based on clinical trial findings for publication in peer-reviewed journals.
- Managed budgetary aspects of clinical trials, negotiating contracts with vendors and ensuring cost-effective resource allocation.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
- Coordinated with other departments such as biostatistics and regulatory affairs to streamline processes and ensure successful project completion.
- Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and Saudi FDA regulations.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Managed around 28 studies, which include Investigator-initiated studies, Multi-centric clinical trials and device trials.
Clinical Research Coordinator-II
JSS Medical Research(CRO)
India
12.2011 - 11.2012
- Collaborated with cross-functional teams to streamline operational procedures.
- Monitored progress of clinical trials, identifying issues and implementing solutions.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
- Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
- Streamlined process for serious adverse event reporting, enhancing safety monitoring efforts.
- Facilitated successful trial completion by closely monitoring study timelines and milestones, ensuring on-time delivery of results.
- Facilitated communication between investigators and regulatory agencies to expedite approvals.
- Managed H1N1 and Seizure studies.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Clinical Research Coordinator
Aravind Eye Hospitals
Coimbatore, India
01.2010 - 12.2011
- Coordinated clinical trial activities, ensuring adherence to regulatory guidelines and protocols.
- Collaborated with investigators and sponsors to develop study timelines and objectives.
- Managed participant recruitment, informed consent processes, and data collection procedures.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Managed 13 Ophatalmology multi-centric studies.
- Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
Education
Master of Science - Clinical Research And Regulatory Affairs
Manipal University
India11-2017
Bachelor of Science - Nursing
Rajiv Gandhi University of Health Sciences
India03-2010
Skills
- SAE/AE reporting
- Site monitoring
- Clinical trial management
- Clinical data management
- Project planning and execution
- Master file management
- Good clinical practices
- Leadership skills
- Problem-solving abilities
- Multitasking
- Excellent communication
- Relationship building
- Overseeing Trial Management
Languages
English
Full Professional
Tamil
Professional Working
Hindi
Professional Working
Arabic
Elementary
Certification
- CCRP certification from SOCRA (Society of clinical research professional, USA).
- ICH-GCP certifications from various trial sponsors.
- IATA certification for shipping regulation related to the transportation of dangerous goods(TDG).(Mayo Clinic, USA)
- Certificate training in phlebotomy techniques from KKESH, Riyadh, Saudi Arabia
Timeline
Clinical Research Manager
St Micheal's Hospital
06.2021 - Current
Quality Assurance Associate
Pharma Medica Research Institute
06.2020 - 06.2021
Clinical Research Coordinator-II
Cliantha Research Inc
08.2019 - 06.2020
Senior Clinical Research Coordinator
King Khaled Eye Specialist Hospital
01.2013 - 04.2019
Clinical Research Coordinator-II
JSS Medical Research(CRO)
12.2011 - 11.2012
Clinical Research Coordinator
Aravind Eye Hospitals
01.2010 - 12.2011
Master of Science - Clinical Research And Regulatory Affairs
Manipal University
Bachelor of Science - Nursing
Rajiv Gandhi University of Health Sciences
Publications:
- Risk Factors for Blindness in Children With Primary Congenital Glaucoma-Follow-up of a Registry Cohort.
Alshigari R, Freidi A, Souru C , Edward DP, Malik R.Am J Ophthalmol. 2021 Apr;224:238-245. doi: 10.1016/j.ajo.2020.12.014. Epub 2021 Jan 6.PMID: 33359680
- Validity, Usefulness and Cost of RETeval System for Diabetic Retinopathy Screening.
Al-Otaibi H, Al-Otaibi MD, Khandekar R, Souru C , Al-Abdullah AA, Al-Dhibi H, Stone DU, Kozak I.Transl Vis Sci Technol. 2017 May 16;6(3):3. doi: 10.1167/tvst.6.3.3. eCollection 2017 May.PMID: 28516001
- Pretarsal skin height changes in children receiving topical prostaglandin analogue therapy for primary congenital glaucoma.
Al-Zobidi M, Khandekar R, Cruz A, Craven RE, Souru C , Malik R, Edward DP.J AAPOS. 2018 Aug;22(4):290-293.e1. doi: 10.1016/j.jaapos.2018.01.019. Epub 2018 May 21.PMID: 29792934
- Prevalence and Determinants of Dry Eye Disease among 40 Years and Older Population of Riyadh (Except Capital), Saudi Arabia.
Yasir ZH, Chauhan D, Khandekar R, Souru C , Varghese S.Middle East Afr J Ophthalmol. 2019 Jan-Mar;26(1):27-32. doi: 10.4103/meajo.MEAJO_194_18.PMID: 31114121
- Determinants of Visual Outcomes in Femtosecond Laser Assisted Cataract Surgery and Phacoemulsification: A Nested Case Control Study.
Khandekar R, Behrens A, Al Towerki AE, May W, Motowa S, Tailor K, Souru C. Middle East Afr J Ophthalmol. 2015 Jul-Sep;22(3):356-61. doi: 10.4103/0974-9233.159762.PMID: 2618047
- Vision Screening of Ophthalmic Nursing Staff in a Tertiary Eye Care Hospital: Outcomes and ocular healthcare-seeking behaviours.
Khan RA, Souru C , Vaghese S, Yasir Z, Khandekar R.Sultan Qaboos Univ Med J. 2017 Feb;17(1):e74-e79. doi: 10.18295/squmj.2016.17.01.013. Epub 2017 Mar 30.PMID: 28417032