Dr.Srividhya Sridharan
Summary
Accomplished clinical research professional with more than 8 years expertise in managing global clinical trials across various specialties. Skilled in project and vendor management, ensuring compliance to ICH/GCP guidelines. Known for exceptional organizational skills, meticulous attention to detail, and strong problem-solving abilities. Holds certifications in ACRP-CCRC, ICH-GCP, IATA, CRIO e-source, Fibro scan, as well as active BLS certification and licensure as a Pediatrician in India.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Clinical Research Manager
American Research Corporation
02.2024 - Current
- Provides education/information about clinical research protocols to associated health care personnel.
- Establishes and maintains a record keeping system to insure adequate documentation of each clinical protocol in accordance with FDA requirements.
- Recruits and enrolls patients who meet the study's inclusion/exclusion criteria.
- Collects study data and provides patient care according to protocol.
- Coordinates and examines varying types of data from multiple sources (medical records, clinical laboratory, patient, etc.) for accuracy and consistency within protocol requirements and in accordance with good clinical practices and sponsor's requirements.
- Assists in evaluating patient response to experimental treatment; observes and records patient's reaction or symptoms in response to treatment; evaluates methodology and quality of data collected and determines need for changes in procedures.
- Assists with development of data summaries and presentation materials; assists with data presentation.
- Routinely reports the status of patient enrollment and study progress to the investigator, department director and the sponsor's representative.
- Generates weekly reports of status of patient enrollment and study progress to Department Director.
- Updates study status board of study progress.
- Assists the Principal Investigator in the recruitment of additional studies.
- Assists Lab and Pharmacy with monitoring inventory of study drug (amount and expiration date), lab tubes and kits. Monitors arrangement for re-stocking of study supplies as required by the protocol, i.e. the case report forms.
- Assists with Investigational Product dispensing, dosing and accountability as required by protocol.
- Assists with collection of vital sign, ECG and other measurements as required by protocol.
- Assists with sample collection, processing and shipment as required by protocol.
- Conducts patient education about the protocol and study medication.
- Screen patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected, evaluated, and modeled collected data.
- Complied with research protocols by providing ongoing quality control audits.
Clinical Research Project Manager
Pinnacle Clinical Research
03.2023 - 12.2023
- To maintain organization calendar (Staffing, visits, events).
- To delegate daily assignments to staff members and perform CRC duties as needed.
- To confirm the visits on e-source and EDC are completed and accurate.
- To maintain study statistics, CRC metrics, labs, pharmacy metrics and regulatory as needed.
- To create trainings and schedules for new staff members and train them appropriately.
- To assist staff with smart goals.
- To assist with budget negotiations and resolving vendor issues.
- To provide effective feedback to direct reports.
- To assess recruitment needs of the studies.
- To conduct study visits as appropriate.
- To conduct 1:1 meeting with staff members.
- To provide effective feedback to direct reports.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Reviewed referral information and kept track of intakes from various referral sources.
- Organized professional with expertise in managing resources and optimizing performance. Proficient in providing valuable insights and supporting decision-making processes. Committed to enhancing productivity and contributing to overall success.
Lead Clinical Research Coordinator
Pinnacle Clinical Research
07.2022 - 02.2023
- Prescreen and Screen patients for various NASH trials as per the protocol criteria.
- Perform fibro scan to assess the NASH diagnosis or as follow up.
- Scheduling patients scheduled, Unscheduled and various ancillary visits according to protocol requirements in CRIO e-source.
- Well experienced in performing various procedures like anthropometry, Vitals, ECG, Fibro scan, phlebotomy, IV cannulation, Lab processing, shipment.
- To take up the roles of backup scheduler, pharmacist when needed.
- Perform various study visits as per the protocol requirements.
- Perform data entries and answer the queries as needed.
- To record AEs/ SAEs as appropriate in a timely manner.
- Maintain the site's Clinical supplies and lab supplies up to date.
- Reach out to sponsors and subjects to answer or assess queries and responses.
- Reach out to Colleagues, team members and managers as needed for site support.
- To collect quality data with multi-tasking.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Coordinator
Pinnacle Clinical Research
09.2021 - 07.2022
- To Screen patients for various gastroenterological studies after thoroughly checking their medical records and history and obtaining ICF.
- Scheduling patients scheduled, Unscheduled and various ancillary visits according to protocol requirements in CRIO e-source.
- Well experienced in performing various procedures like anthropometry, Vitals, ECG, Fibro scan.
- To record the changes in the concomitant medications, any new adverse events during each visit.
- Promptly record any SAE reported by the patients and notify the Sponsor within 24 hours regarding the same.
- Record the patients visits in IRT and dispense appropriate medications and record onsite dosing and monitor diaries according to protocol requirements.
- Experienced in calling patients to schedule and notify of anything regarding to the study.
- Well experienced in data entry and resolving various queries by monitors during IMV for various EDC.
- Well experienced in handling various queries by the Sponsor through emails or calls.
- Experienced in handling various monitoring visits both in person and remote.
- Experienced in recording the visits, uploading documents, tagging the investigators and internal team, sign any e-regulatory documents, sample acknowledgements in CRIO.
- Well experienced in collecting quality research data avoiding protocol deviations.
- 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.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Maintained compliance with protocols covering patient care and clinical trial operations.
Clinical Research Coordinator
SMO, HCA Healthcare
02.2021 - 08.2021
- Chart-screening Doctor's EMR daily for patients who fit the studies inclusion/exclusion criteria.
- Coordinate scheduling of patient visits and obtaining Informed Consent.
- Experience with hands on patient care, vitals, and phlebotomy.
- Experience with lab shipping according to IATA guidelines.
- Experience in entering the CRFs in EDC.
- Experience with dispensing IP and training patients on how to use / study drug compliance.
- Storing IP and logging temperature.
- Maintain regulatory binder on-site including training log, delegation log.
- Familiarity with reading Protocols for multiple studies.
- Familiarity with all aspects of case-management of protocol participants.
- Familiarity with Monitor visits.
- Experience in handling trials on Colon cancer, Ulcerative Colitis, Celiac Disease, Crohn's disease, Stable Angina, Heart Failure, Hypertension.
Principal Investigator
Sikkim Manipal Institute of Medical Sciences
01.2013 - 01.2016
- A three-year study on Clinical Spectrum and Microbial profile of Urinary Tract Infection in 1 month to 12 years age group in a tertiary care hospital and completed the dissertation as the principal investigator.
- Conducted interviews with witnesses and clients.
- Collected, analyzed and interpreted information, documentation, and physical evidence associated with investigations.
- Documented findings and prepared detailed reports.
- Carefully documented statements, observations, and evidentiary materials.
- Conducted thorough face-to-face interviews with employers, families, neighbors, friends, and suspects, and documented investigative findings.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Complied with research protocols by providing ongoing quality control audits.
Medical Doctor
Pondicherry Hospital
04.2010 - 11.2012
- Diagnosed and treated patients suffering from chronic conditions.
- Reviewed patient allergies, problems, medications, and immunization statuses.
- Educated patients and families on benefits of healthy diet and adequate exercise.
- Identified opiate-free pain control methods to reduce usage of overprescribed narcotics.
- Treated and monitored care of geriatric patients at local long-term care facility.
- Maintained confidentiality of patient information according to federal guidelines and regulations.
- Created treatment plans balancing medical expertise, patient goals and individual compliance levels.
- Delivered expert consultation and referrals for appropriate and effective treatment plans.
- Monitored and recorded patient progress, prompting timely and appropriate interventions.
- Coordinated and integrated health care resources for community-based programs.
- Completed routine physical exams and diagnostic tests to provide accurate diagnosis.
- Treated acute and chronic conditions to reduce symptoms and improve health.
Education
M.D. - Pediatrics and Neonatology
Sikkim Manipal Institute of Medical Sciences
01.2016
M.B.B.S - Bachelor of Medicine and Bachelor of Surgery
Pondicherry University
01.2010
Skills
- Fibro-scan
- Phlebotomy
- Lab processing and Shipping
- Pre/post -screening
- Randomizing patients
- Perform Data entries promptly
- Capability to manage multiple monitoring visits (PSV, SIV, IMV, COV)
- Study Startup
- IP management
- Regulatory and Pharmacy management
- Manage Site inventory and order Clinical supplies
- CRIO e-source
- Veeva Vault
- Medi data
- Clin Track
- IBM Zelta
- Clario
- Various IWRS and imaging software
- EPIC
- Protocol development
- Study design
- Site monitoring
- International regulations
Research Studies Summary
- Institutional- Research study on Urinary Tract Infection, child abuse
- FDA regulated- Around 40 trials for various medical device, GI, Cardiology, Hepatology, Obesity trials
Certification
- ACRP- CCRC certification
- ICH-GCP certification
- IATA certification
- CRIO e-source certification
- Fibro scan Certification
- Active BLS
- Licensed Pediatrician in India
Timeline
Clinical Research Manager
American Research Corporation
02.2024 - Current
Clinical Research Project Manager
Pinnacle Clinical Research
03.2023 - 12.2023
Lead Clinical Research Coordinator
Pinnacle Clinical Research
07.2022 - 02.2023
Clinical Research Coordinator
Pinnacle Clinical Research
09.2021 - 07.2022
Clinical Research Coordinator
SMO, HCA Healthcare
02.2021 - 08.2021
Principal Investigator
Sikkim Manipal Institute of Medical Sciences
01.2013 - 01.2016
Medical Doctor
Pondicherry Hospital
04.2010 - 11.2012
M.D. - Pediatrics and Neonatology
Sikkim Manipal Institute of Medical Sciences
M.B.B.S - Bachelor of Medicine and Bachelor of Surgery
Pondicherry University
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