PRACHI SALVI
Wallington,NJ
Summary
Proactive Clinical Coordinator excited to transition into a new position where leadership and clinical coordination abilities can be utilized. Skilled in task delegation, staff recruitment, and scheduling. Committed to ensuring staff is compliant with all safety and health standards and protocols.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Lead Clinical Study Coordinator
Metropolitan Eye Research and Surgery Institute
Palisades Park, NJ
03.2021 - Current
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Developed clinical trial documents and standard operating procedures (SOPs) at site.
- Ensured TMFs and facilities were audit ready.
- Managed protocol-related activities from start-up through implementation and site close-out procedures.
- Performed investigational product (IP) and medical device drug accountability inventory.
- Delivered and exceeded project enrollment for clinical research studies by identifying prospective candidates from electronic databases, and physician referrals.
- Demonstrated high level of initiative and creativity while tackling difficult tasks while working effectively in fast-paced environments.
- Monitored proper clinical area appearance, sterilization, and restocking by creating daily, weekly, and monthly assistant task lists.
- Worked collaboratively with all team members (i.e. physicians, nurses, and hospital staff) to ensure services are well coordinated and delivered to patients in timely manner.
Clinical Study Coordinator
Eastside Comprehensive Medical Center
New York, NY
06.2020 - 02.2021
- Adhered to standards in all areas, including data collection, research protocols, and regulatory reporting.
- Discuss study protocols with patients and verified informed consent documentation.
- Gathered, processed, and shipped lab specimens.
- Arranged transportation for patients, coordinating transit times with appointment scheduling.
- Exceeded goals through effective task prioritization and great work ethic.
- Coordinated, monitored, assigned, and documented patient and clinical care activities.
- Conducted patient interviews to gather health history, vital signs, and information about current medical issues.
- Collected, evaluated, and modeled collected data into various EDC (Medidata, Veeva, RedCap, OpenClinica, IBM Clinical, Oracle Inform, etc) and IRT (Almac, Signant Health, Medidata Rave).
- Gained extensive knowledge in data entry, analysis and reporting.
Clinical Research Intern
CCRP LLC
Remote
11.2018 - 10.2019
- Helped in designing of source documentation and standard operating procedure for clinical trials.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
- Assisted in monitoring review of collected data and regulatory binder.
- Acquired and maintained strong understanding of FDA requirements.
- Adhered to good clinical practices, operating procedures, and regulatory requirements.
- Gathered and evaluated quality assurance data to identify issues and improve process efficiency
Special Education Assistant Teacher
Bernice Chatman Freeman Elementary School
08.2016 - 11.2018
- Delivered personalized educational, behavioral, and emotional support to individual students to enable positive learning outcomes.
- Documented student behaviors, interventions, and outcomes to enable lead teacher to address pertinent issues.
- Delivered efficient instruction by assisting with lesson planning and materials preparation.
- Liaised one-on-one with learners to provide additional support tailored to specific learning needs.
- Established professional relationships with parents and other teachers to increase rapport and support
Substitute Teacher
Carrollton Farmers Branch ISD
Carrollton, TX
09.2015 - 05.2016
- Followed classroom plans left by class teacher to continue student education and reinforce core concepts.
- Responsibly took attendance, maintained classroom cleanliness, and explained homework to students
- Repeatedly requested as substitute teacher by teachers based on excellent past referrals and trusted performance.
Research Associate
Xcelris Labs LTD, India
Ahmedabad, Gujarat
06.2013 - 06.2014
- Developed research proposals, identified research objectives and create research plans to monitor clinical trials, and took detailed notes on activities
- Handled “Identification of Single Nucleotide Polymorphism in genes related to alcohol metabolism” under Senior Research associates’ guidance and performed DNA extraction from saliva and all other required responsibilities
- Recognized for developing standard protocol for DNA isolation.
- Maintained data and recorded source documentation following premium recording practices.
- Analyzed and interpreted patterns and trends.
Research Intern
Shree Krushna Gene Lab And Research Center- India
Rajkot, Gujarat
12.2012 - 04.2013
- Completed research, compiled data, updated spreadsheets and produced timely reports for research project “Common six Beta – Thalassemia mutation” and evaluated collected data by executing scientific practices, ensuring all safety protocols
- Collected data for Thalassemia gene mutation from over 50 participants and recorded findings using self-designed questionnaire
- Organized records, maintained inventory equipment including Centrifuge, REAL time PCR and developed reagents and data material for all scientific processes
- Visited field sites to screen potential subjects to record study data and understand suitability for studies
- Performed critical documentation such as personal waivers and informed consent forms
- Responsibly conducted interviews with research subjects, recorded primary data, and delivered assessments and evaluations to supervisors
- Organized summaries of research findings and presented them to managers.
Education
Certificate - Clinical Research
CCRP LLC
Wilmington, DE05.2019
Master of Science - Biotechnology
Bhagwan Mahavir College of Biotechnology
India04.2013
Bachelor of Science - Biotechnology
Bhagwan Mahavir College of Biotechnology
India05.2011
Skills
- Fluent verbal and written communication skills
- Research medical best practices and regulations on fingertips
- Complete understanding of medical terms
- Proficient with Microsoft Office Suite
- Expert in quality assurance and Data entry in EDC
- Creative Thinking
- Strong electronic medical record-keeping skills
- Excellent two-way coordination with supervisors and subordinates
Certification
ICH GCP March 2019 to Present
Certified Clinical Research Professional May 2019 to Present
Good Clinical Practice March 2023 to March 2026
IATA Certification January 2022 to Present
Timeline
Lead Clinical Study Coordinator
Metropolitan Eye Research and Surgery Institute
03.2021 - Current
Clinical Study Coordinator
Eastside Comprehensive Medical Center
06.2020 - 02.2021
Clinical Research Intern
CCRP LLC
11.2018 - 10.2019
Special Education Assistant Teacher
Bernice Chatman Freeman Elementary School
08.2016 - 11.2018
Substitute Teacher
Carrollton Farmers Branch ISD
09.2015 - 05.2016
Research Associate
Xcelris Labs LTD, India
06.2013 - 06.2014
Research Intern
Shree Krushna Gene Lab And Research Center- India
12.2012 - 04.2013
Certificate - Clinical Research
CCRP LLC
Master of Science - Biotechnology
Bhagwan Mahavir College of Biotechnology
Bachelor of Science - Biotechnology
Bhagwan Mahavir College of Biotechnology
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