Sarita Raha, BSN, RN
Garland,Texas
Summary
Accomplished Clinical Research Associate with more than 4 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
8
8
years of professional experience
Work History
Clinical Research Associate II
ICON Clinical Research
05.2022 - Current
- Improved patient enrollment by developing and implementing effective recruitment strategies.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Streamlined clinical trial processes for increased efficiency, utilizing strong organizational skills.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
Clinical Research Associate II
IQVIA
09.2020 - 05.2022
- Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work and good clinical practice
- Support development of project subject recruitment plans on a per site basis
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
- Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Clinical Research Associate
Medpace
08.2019 - 09.2020
- Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, Medpace/Sponsor SOPs, and applicable regulatory requirements
- Responsible for overall site management for assigned sites, including written and verbal communication and scheduling of monitoring visits
- Responsible for completion of visit reports, follow up letters, and maintenance of study-related databases.
Registered Nurse in the Neonatal Intensive Care Unit
Parkland Health and Hospital System
01.2016 - 08.2019
- Completed the four-month NICU Nursing residency program
- Went from working under a preceptor to an autonomous nurse who cares for premature infants and knows what changes to look for in correlation with their well-being
- Super User for Philips Physiological Monitors
- Proficient in EPIC Electronic Health Records
- Perform head to toe assessments on premature infants
- Administer medications to premature infants (PO, IV, IM)
- Change fluids using sterile procedures (TPN, Lipids, IV medications)
- Implement treatment protocols ordered by the Nurse Practitioner or Neonatologist
- Educate parents on the daily care and treatments of premature infants
- Prepare infants to transition from the NICU to their homes.
Education
Bachelors of Science, Nursing -
Midwestern State University
Wichita Falls, TX05.2015
Pre-Requisite Courses, Nursing -
Texas Women's University
Denton, TX05.2012
Skills
- Research and Development
- Site monitoring
- Drug development
- Educational Activities
- Patient Safety
- Report Writing
- Data Collection
- Team Training
- Quality Control
- Completing regulatory documents
Research
(Dallas, TX - March 2016) Performed an Evidence Based Practice Study on Noise Reduction in the NICU, Used a digital sound level meter to measure decibel levels of ambient sound created by NICU staff, The data that was collected suggests that during routine assessments with one or more nurses present, the average decibel levels are comparable to those in rooms with respiratory equipment, such as a CPAP machine or an oscillator. This decibel level was found to be within a therapeutic range and will not harm the infant., Outcomes and results were presented at an educational seminar sponsored by Parkland Health and Hospital System
References
Available upon request
Timeline
Clinical Research Associate II
ICON Clinical Research
05.2022 - Current
Clinical Research Associate II
IQVIA
09.2020 - 05.2022
Clinical Research Associate
Medpace
08.2019 - 09.2020
Registered Nurse in the Neonatal Intensive Care Unit
Parkland Health and Hospital System
01.2016 - 08.2019
Bachelors of Science, Nursing -
Midwestern State University
Pre-Requisite Courses, Nursing -
Texas Women's University
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