Experience

Pillar Clinical Research, LLC

• United States
• Research Services
• 1 - 100 Employee

• Clinical Scientist

  • Sep 2020 - Present

  Preparing internal and external scientific presentations, research manuscripts and review articles. Providing sound scientific and clinical advice in inpatient and outpatient clinical studies. Designing, developing, maintaining clinical databases and analyzing clinical data from labs and psychometric testing. Assisting with design, development, implementation, of clinical studies and investigator-initiated research trials. Authoring clinical trial protocols, Investigator brochure, ICF, SOPs. Ensuring quality control of source documents and training materials. Assisting in recruitment and retention of subjects for clinical research. Identifying subjects suitable for protocols through personal interviews, psych eval and analyzing medical records. Diagnosing subjects with the aid of DSM-5, structured clinical interviews like MINI, and SCID Diagnosing substance use, prescription drug addiction and drug withdrawals Assessing the severity of symptoms in schizophrenia, Bipolar, depression and psychosis through clinical rating scales like PANSS,YMRS, MADRS, HAM-D,HAM-A, SIGMA, CGI-S,CGI-I Administering dementia and cognitive rating scales in subjects with Alzheimer and schizophrenia Tracking the progress of subjects in research with scheduled visits, rating scales and laboratory data. Reporting serious adverse events and medical safety data to sponsor and review boards. Participating in study budget negotiations with sponsors. Developing site plans for executing clinical trials. Assisting in collecting and maintaining research related documents in compliance with HIPAA. Training site staff on new protocols. Show less



Green Light Clinical

• Arlington, TX

• Medical Science Liaison/Medical Safety Associate

  • Dec 2019 - Jul 2020

  MSL Duties Providing Scientific support to clinical operations, BD, MA Developing publications like abstracts, case studies, posters Providing scientific advise across all therapeutic areas to both internal and external stakeholders Developing partnerships with investigators, KOL and healthcare professionals Participating in sponsored clinical trials including planning and study design, site identifications and IRB submissions Providing support and training to staff as SME Writing SOP's and work instructions. Designing and delivering formal scientific training Safety Associate Duties Creating Initial and follow up cases for SAE Sending safety queries to sites for invalid and additional data required for case processing Case processing of Serious Adverse Events in safety database (Intake, Triage, Full data entry, distribution) according to SOP and project specific safety plans Coding of SAE medical history, concomitant medications, diagnostic tests from MEDRA and WHO DD. Determining whether SAE meets FDA reporting requirements through triage, additional follow ups with medical monitor and sponsor Perform quality review of SAE in safety database Developing case narratives from SAE report forms, CRFs and other relevant documentation Submission of SUSARs to FDA and TGA Reconciliation of AE from clinical database (Daily, Weekly, Monthly) Assisting in developing reports and safety communications with sponsors. Show less



Insite Clinical Research

• United States
• Research Services
• 1 - 100 Employee

• Clinical Rater

  • Jul 2016 - Nov 2019

  Screening subjects based on their inclusion and exclusion criteria Administering rating scales like MINI,PANSS,CSSRS,SAS,BARS,AIMS,YMRS,MADRS,SCoRS CGI-S/I,SARA,GAF,EQ5-DL,SCoRS,MCCB,ADASCoG Responding to queries from third party vendors Reporting AE and SAE to sponsors Attending rater training sessions and Investigator meetings on behalf of our research facility Screening subjects based on their inclusion and exclusion criteria Administering rating scales like MINI,PANSS,CSSRS,SAS,BARS,AIMS,YMRS,MADRS,SCoRS CGI-S/I,SARA,GAF,EQ5-DL,SCoRS,MCCB,ADASCoG Responding to queries from third party vendors Reporting AE and SAE to sponsors Attending rater training sessions and Investigator meetings on behalf of our research facility



Universirty Hills Research

• Irving

• Clinical Rater/ Coordinator

  • Jul 2015 - Apr 2016

  Implementing SOPs and protocols. Getting ICF and other consents before screening Subject selection based on Inclusion/Exclusion criteria. Communicating with sponsor about SQDF,PDF,AE and SAE Retrieving medical records of subjects on priority basis Scheduling subjects according to their visit windows and protocol requirements Conducting subject visits in coordination with the PI Collecting clinical specimens and manage patient information database. Processing samples like urine, stool, sputum, body tissues, exudates, and blood including plating of the samples on appropriate medium Issuing study drug according to the blinding procedures in protocol Drug reconciliation Uploading data to EDC and answering queries from the sponsor Well versed with 1572, IRB requirements and regulatory documents Participating in quality audit with the study monitors and fixing any errors in the source documents Show less



Sevasadan Nursing Home

• Mancherial

• Primary Care Physician

  • Jan 2003 - Jun 2007

  Providing Emergency care, Outpatient care, ambulatory and inpatient care to patients. Providing first line of treatment in medical emergencies and traumas Treating patients with chronic conditions such as diabetes, hypertension, Asthma, COPD, arthritis. Treating patients with common seasonal infectious diseases like cholera, dengue and malaria. Diagnosing and treating patients with mental illness like anxiety, depression, schizophrenia, and Bipolar disorders. Counseling patients and providing treatment in substance use disorders like nicotine, benzodiazepines and alcohol. Immunizing children and tracking their development status. Participating in research, statistics and drug studies in collaboration with pharmaceutical companies. Show less