Rhea Sharma Rachal

Clinical Research - Operations, Coordinator Training & Mentoring

Stafford, TX 77477

ad32xv@r.postjobfree.com

+1-281-***-****

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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