Dr Shakthibala R R
Clinical research Professional
chennai,TAMIL NADU
Summary
Hardworking clinical research professional successfully leads site evaluations, initiations and closeouts. Well-versed in Global trials and of picks up new procedures quickly. Offering advanced planning, problem-solving and communication skills developed over 7+ years of clinical research success. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
16
16
years of professional experience
3
3
Languages
Work History
Senior Clinical Research Associate
JSS Medical Research Asia pacific Pvt ltd
4 2024 - Current
- Outstanding project management abilities to coordinate many trial details and juggle timeline
- Meticulous attention to detail regarding data, documentation, protocols, etc
- Strong analytical and critical thinking skills to analyze data, reports, processes and find potential improvements
- Ability to exercise independent judgment when making recommendations and decisions impacting trials
- Excellent organization skills to manage multiple priorities and deadlines
- Lead training initiatives and onboarding of research staff at trial sites; provide ongoing support and education
- Conduct on-site and remote monitoring visits of trial locations to review regulatory documentation, drug storage procedures, equipment calibrations, etc
- Identify any deficiencies or training issues
- Serve as main point of contact for questions, issues, or feedback from site personnel; provide guidance and leadership
- Develop contingency plans for trial delays, enrollment issues, site staffing problems etc
- Conduct benchmarking studies on site metrics from past trials to set performance targets.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Improved clinical trial efficiency by streamlining data collection and management processes.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
- Contributed to the development of study protocols, informed consent forms, and case report forms to ensure consistency across clinical trials.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
- Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Gathered, processed, and shipped lab specimens.
- Complied with research protocols by providing ongoing quality control audits.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Facilitated focus group sessions with project patients.
- Reviewed referral information and kept track of intakes from various referral sources.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
Clinical Research Associate
JSS Medical Research Asia pacific Pvt ltd
01.2021 - 03.2024
- Conduct of Clinical Study Visits (Site selection visit ,Site Initiation Visits, Site Monitoring Visits both remote and onsite, Close-out visits)
- Identification of new sites for clinical trials; analysis site capability and performing site feasibility for assigned Study
- Identification and reporting of PDs/ AEs/SAEs/AESIs
- Reviewed essential/regulatory documents, ensuring Investigator Site Files (ISF) is accurate, current, and identical to Central Site File (CSF)
- Ensure all applicable Safety Reports/ CIOMS/ IND letter/s availability on ISF followed by regular reconciliation of EC submission and acknowledgment
- Verify data versus source documentation and validate CRF entries
- Expert knowledge of ICH guidelines, GCP principles, FDA regulations and other standards related to clinical trials
- Leadership skills to manage teams, provide excellent customer service to sites, and troubleshoot complex issues
- Proficiency with key software platforms for clinical trials like EDC programs, CTMS tools, and eTMF systems
- Monitor patient recruitment and enrollment numbers; recommend and assist with recruitment strategies to meet targets
- Review complex datasets and information from trial sites related to safety and efficacy; ensure accuracy and completeness
- Write visits reports, summaries, and other central documents to capture key trial information for lead scientists and regulatory submissions
- Track site performance benchmarks and metrics related to enrollment, data quality, protocol adherence
- Develop solutions for operational challenges that arise; adjust plans to minimize impact on trial execution
- Lead or assist sponsor companies with final analysis, evaluation, and conclusions of trial data
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Implemented new technologies in the management of clinical trials, streamlining data collection and reporting processes.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Prepare sites and systems for regulatory inspections; may participate or present in inspections
- Liaise between sponsor companies and central lab facilities coordinating sample analysis.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Clinical Trial Assistant
JSS Medical Research India Private Limited
07.2018 - 12.2020
- Working knowledge of clinical research regulations and ICH GCPs, good understanding of Clinical Research Processes and SOPs
- Support CRAs (all levels) with in-house coordination activities, update ISF, CSF and PMF effectively with Investigator, Site Staff, CRAs, CTLs and CPMs to contribute towards smooth project delivery
- Flexible to take up add-on responsibilities & deliver satisfactorily all the tasks assigned by the respective line manager/ PM to support the project deliverables &/or department improvisation
- Demonstrate and maintain customer focus
- Remain aligned to common organization objectives and individual project deliverables
- ETMF -Management.
- Organized investigator meetings to provide updates on trial progress and discuss potential improvements or adjustments to study plans.
- Maintained up-to-date knowledge of industry best practices by attending relevant conferences, workshops, and webinars.
- Facilitated efficient site initiation visits by preparing necessary documents and providing training on trial protocols.
- Collaborated with investigators to address any concerns or issues that arose during the course of the clinical trial.
- Ensured timely submission of safety reports, supporting overall patient safety throughout the trial process.
Chief Consultant
Healing Drug Multispecialty Hospital
05.2014 - 12.2017
- Contributing clinical expertise to patient care
- Verifying complex diagnoses and facilitating treatment plans.
Residential Medical Officer
Residential Medical Officer
05.2008 - 05.2010
- Applied medical knowledge and skills for the diagnosis, treatment, management, and prevention of disease and other medical conditions
- Ensuring the highest standards in patient care were maintained.
- Educated patients on self-care strategies and lifestyle modifications needed for managing chronic illnesses effectively.
- Developed innovative approaches to patient care, resulting in greater adherence to treatment plans and improved health outcomes.
- Enhanced interdisciplinary communication by collaborating with healthcare teams, ensuring proper treatment plans for patients.
- Served as a mentor to junior physicians, sharing clinical knowledge and fostering professional growth within the medical team.
- Promoted a culture of patient-centered care by actively involving patients in their treatment plans and providing personalized support throughout the recovery process.
- Evaluated the effectiveness of current treatment strategies using established criteria to drive continuous improvement efforts.
- Managed medication regimens for various patient populations, addressing potential side effects or drug interactions proactively.
- Collaborated with specialists on complex cases, ensuring optimal patient outcomes through coordinated care efforts.
- Improved patient satisfaction by providing compassionate and comprehensive care to diverse populations.
- Participated in quality improvement initiatives aimed at enhancing overall patient safety within the residential medical setting.
Education
Advanced PG Diploma in Pharmacovigilance -
Cliniminds Institute of Health Science, Training & Management
Doctor of Medicine (Siddha) - undefined
Govt. Siddha Medical College
Bachelor of Siddha Medicine and Surgery - undefined
Govt. Siddha Medical College
Skills
Team Leadership Qualities
Therapeuticexperience
- Acute pancreatitis
- Thrombocytopenia
- COVID-19
- Vitiligo
- Metastatic Breast cancer
- Hepatitis C
- Alcoholic Liver Disease
- Visceral Leishmaniasis
- Diabetic Foot Ulcers
- Relapsing Remitting Multiple sclerosis
- HIV-1
Affiliations
Tamil Nādu Siddha Medical Council-2007 to till date
Specializedtraining
- ICH GCP E6_R2 Training, 2023
- 21 CFR Part 11, 2023
- E3_Guideline, 2023
- FDA Regulations for Good Clinical Practice, 2023
- Good Clinical Data Management Practices, 10/2013
- Good Documentation Practice, 2023
- ICH GCP E6_R2, 2023
- Indian GCP, 2023
- New Drugs and Clinical Trial Rules 2019, 2023
- Changes in Regulations Impact on Clinical Research in India, 2023
- ISO 9001:2015 Quality Management Systems Manual, 2023
- ISO_14155_2020, 2023
Timeline
Clinical Research Associate
JSS Medical Research Asia pacific Pvt ltd
01.2021 - 03.2024
Clinical Trial Assistant
JSS Medical Research India Private Limited
07.2018 - 12.2020
Chief Consultant
Healing Drug Multispecialty Hospital
05.2014 - 12.2017
Residential Medical Officer
Residential Medical Officer
05.2008 - 05.2010
Senior Clinical Research Associate
JSS Medical Research Asia pacific Pvt ltd
4 2024 - Current
Advanced PG Diploma in Pharmacovigilance -
Cliniminds Institute of Health Science, Training & Management
Doctor of Medicine (Siddha) - undefined
Govt. Siddha Medical College
Bachelor of Siddha Medicine and Surgery - undefined
Govt. Siddha Medical College
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