Clinical Operations Research
Resume:
Rhea Sharma Rachal
Clinical Research - Operations, Coordinator Training & Mentoring
Stafford, TX 77477
*****.***@*****.***
Authorized to work in the US for any employer
Work Experience
Director, Clinical Operations
Clinical Trial Network - Houston, TX
February 2023 to Present
Director Clinical Operations - RNA / BNRC - Strengths in Biological & Biospecimen Collections & Neurology Psych Therapeutic Area Clinical Phase 2,3 & 4 Studies. Sister Company to CTN (Mother Ship) Business Development & New Territory Encounters, Sponsors, Stakeholders & Managers across all levels. Training/Mentoring - Hiring of New staff on board handling day to day operations across Boston/ Houston sites.
Negotiating new contracts/ Applying regulatory packets - turnaround time 48 hours, New Study Start Ups - 6 weeks turn around time. PI On boarding and Staff feasibility and accountability/accommodation
- turnaround period 2 weeks.
Director of Clinical Trial Operations
Alpha Research institute llc - Houston, TX
April 2022 to Present
Team building
Site monitoring
Site-Start ups
New studies initiatives
Ongoing study management
Funds and In house vendor or third party management Reporting directly to president & treasurer
Recruitment planning with Marketing & outsourced recruitment vendors Target Accomplishments
Day-to-Day facilitations of studies with study coordinators Maintaining ICH-GCP compliance with study operations Applying for Regulatory documents to the Sponsor, using Central/Local IRB's, maintaining ISF binders. Coordinating with staff and recruitment teams on day to day basis for study subject recruitments Participating in facilitating in Sleep center activities with Sleep center coordinators and supervisor Facilitating communications with new sponsors to get new studies on board Communicating with study CRA's/ Budget and Contract personnels and Regulatory personnels from the Sponsor/CRO team
Making sure smooth communication between chain of command up and down in the organization to achieve organizations goal
Clinical Operations Manager
Alpha Research Institute LLC
November 2021 to Present
Responsible for oversight of clinical operations across all sites. This includes direct oversight of day-to- day management of recruitments at all sites.
• Monitors and ensures clinical and operational performance goals are maintained across the Organizations. Works with clinical management to optimize staffing, appointment schedules, workflows policies and procedures, as needed to meet goals.
• Responsible for ensuring an excellent patient experience and that patient complaints and grievances are addressed and resolved in a timely and responsive manner.
• Participate and provide leadership with Alpha Marketing team and ensure effective implementation and maintenance of concepts, principles and processes across social media and Company Website.
• Develop, review and update policies, procedures, process improvement, training, and evaluation that help support efficient organization workflows, productivity, quality improvement and customer service.
• Monitor and ensure clinical and operational performance standards are maintained at the assigned sites(s). Lead site efforts to achieve established goals for productivity and quality goals.
• Ensure communication of goals, objectives, policies, and procedures both up and down the chain of command through meetings, huddles, and other forms of communication.
• Develop, conduct, and ensure compliance for all staff for required training related to clinical operations compliance.
Sales and Marketing Manager
Dermasoft Inc - Sugar Land, TX
December 2019 to July 2021
Opened sales front in Houston Tattoo Supply Market Developed skills for marketing and conducted marketing campaigns (Instagram/Facebook/CRM) to reach out to the Houston Tattoo Artists Community
Created Order forms
Inventory management
Conducted 1st Dermasoft Inc BOOTH set up at NRG Stadium Sales Representative
Queries/and customer management
Square management for Inventory/Sales/P&L
Monthly/Weekly meetings with Dermasoft Inc management to project monthly sales targets/ new clients/ Discussing marketing campaigns/ Mobile Truck Routing Schedule/ Inventory Creating Excel spreadsheet, gathering information for new clients in California and New York market Marketing and Sales calls/emails/messages to Artists to increases sales, weekly. Clinical Trial Project Manager
Paurotis Pharma Pvt Ltd. - New Delhi, Delhi
December 2017 to January 2021
• Converted Clinical Practice to Clinical Research Ensuring Ethical Conduct in Multi-centric Trials Funding, Profit & Loss
• Worked on phases, designs and attributes of clinical study strategies for endpoint selection in Clinical Trials (CTMS, EDMS)
• Assisted the clinical team with the preparation, handling distribution, filing and archiving of clinical documentation and reports (TMF’S)
• Conducted periodic review of study files for completeness.
• Handled maintenance of tracking information of the clinical Trial Supplies.
• Tracked and managed the CRF’s, queries and clinical data flow.
• Acted as the central contact for the clinical team for designated project communications, correspondence and associated documentations.
• Accompanied Clinical Trial Monitors on site visits to assist with monitoring duties upon completion of the required training.
Clinical Trial Manager – Cardiology
Translumina Therapeutics LLP - New Delhi, Delhi
February 2016 to November 2017
• Reviewed CRFs and electronic clinical edit programs and generate and resolve data queries
• Identified and complied with working instructions and core operating procedures
• Handled external vendor management system. Ensured negotiation and quality service on budget and time.
• Communicated closely with monitors, sponsors, and Investigators
• Trained Sales & Marketing team to achieve enrolment counts Clinical Research Data and Management Coordinator - Cardiology Fortis Hospital - New Delhi, Delhi
January 2014 to December 2015
• Assisted in the designing of the Protocol/ Case Report Form, Precise documentation required for site initiation, CTA/Informed Consent/Feasibility Checklist
• Documented Data Management of existing sites and
• Conducted training for E-CRF to Clinical Data Coordinators Clinical Research Coordinator – Microbiologist (Infectious Disease) Fortis Hospital - Gurgaon, Haryana
July 2013 to January 2014
• Analyzed and collected patient data to identify antibiotic usage and treatment outcomes, in Critical care (Intensive Care Unit).
• Conducted Retrospective, single-arm, single-center study, and determined culture sensitivity patterns to compare treatment and predicted outcomes by calculating APACHE. Education
Certificate in Artificial Intelligence & Machine Learning Massachusetts Institute of Technology
February 2023 to October 2023
MSc in Clinical Research
Monash University
2015
BSc in Biochemistry & Microbiology
University of Sheffield
2013
Science & Technology
University of Sheffield
2010
Skills
• IATA, Good Clinical Practice (GCP), Digital Marketing Course
• Technical: Microsoft Office: Word
• Excel
• PowerPoint
• SPSS (Biostatistics)
• Stata Languages
• English
• Hindi
• Clinical Research
• Clinical Trials
• Critical Care Experience
• GLP
• ICU Experience
• Microbiology
• Research
• Laboratory Experience
• Regulatory reporting
• Quality audits
• Network monitoring
• Data entry
• FDA regulations
• Data visualization
• Analytics
• Information governance
• Ophthalmology
• Documentation review
• Management
• Data science
• Conflict management
• Analysis skills
• SharePoint
• Quality Assurance
• Data Analysis
• SQL
• CRM software
• Clinical development
• Patient monitoring
• Google Docs
• Social media management
• Data management
• Budgeting
• Oracle
• Microsoft Project
• CGMP
• Supply chain
Links
http://www.linkedin.com/in/rheaanand24
Certifications and Licenses
IATA, Good Clinical Practice (GCP), Digital Marketing Course CCRC
CCRP
IATA Certification
February 2023 to Present
Artificial Intelligence & Machine Learning
October 2023 to Present
MIT Professional Education
Assessments
Medical terminology — Completed
July 2021
Understanding and using medical terminology
Full results: Completed
Work style: Reliability — Proficient
October 2021
Tendency to be reliable, dependable, and act with integrity at work Full results: Proficient
Attention to detail — Proficient
July 2021
Identifying differences in materials, following instructions, and detecting details among distracting information
Full results: Proficient
Spreadsheets with Microsoft Excel — Proficient
August 2021
Knowledge of various Microsoft Excel features, functions, and formulas Full results: Proficient
Management & leadership skills: Impact & influence — Proficient January 2022
Choosing the most effective strategy to inspire and influence others to meet business objectives Full results: Proficient
Sales skills — Proficient
June 2021
Influencing and negotiating with customers
Full results: Proficient
Project timeline management — Proficient
January 2022
Prioritizing and allocating time to effectively achieve project deliverables Full results: Proficient
Data entry: Attention to detail — Proficient
October 2021
Maintaining data integrity by detecting errors
Full results: Proficient
Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field.
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