July Andrea Pira Romero
Accountant
Fontibon,DC
Summary
Detail-oriented and results-driven professional with solid experience in research methodologies, data management, and clinical trial processes. Expert in managing key documentation, strategic financial oversight, payments, and regulatory compliance. Recognized for exceptional skills in data entry and precise data handling, as well as effective collaboration with multidisciplinary teams. Committed to ensuring the successful execution of clinical trials through rigorous organization and a proactive approach.
Overview
10
10
years of professional experience
Work History
Sr. Clinical Trials Assistant
ReSolution Latin America
Argentina And Mexico
03.2024 - 01.2025
- Responsible for maintaining and organizing documentation in the eTMF for clinical studies from various sponsors, ensuring quality, accurate entry, and audit readiness.
- Managed, tracked, and recorded financial transactions, including payments to ethics committees, research committees, patient visit reimbursements, and regulatory fees. Prepared detailed reports to ensure accurate financial oversight and compliance.
- I provide efficient support to Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team by collaborating directly with sites to obtain documents related to site selection. I assist in the collection, review, and follow-up of essential documentation, ensuring regulatory compliance for submissions to Invima, Cofepris, or Anmat within established project timelines. My proactive approach ensures seamless coordination and contributes to the efficient execution of regulatory processes.
- Built and maintained strong relationships with research sites, interacting with clients to address study-specific matters, resolving escalations related to documentation, and ensuring adherence to study metrics.
- Worked with cross-functional teams to optimize clinical trial execution and contributed to the development of study materials, ensuring clarity and compliance with regulatory guidelines.
- Project managers and research sites in planning, organizing, and coordinating clinical studies, contributing to report preparation and escalating project risks as needed.
- Streamlined clinical trial documentation by organizing and maintaining accurate records, ensuring smooth study progress with meticulous attention to detail in data entry and filing tasks.
- Ensure project success by completing technical, logistical, and administrative tasks while maintaining updated procedures, guidelines, and documentation.
In-house CRA / Clinical Trials Assistant
PRA Health Sciences
Colombia, Bogota D.C.
01.2023 - 03.2024
- Responsible for maintaining clinical study documentation in eTMF, ensuring quality, review, and audit readiness. Provide efficient support to CRAs by managing document entry, organization, and physical document dispatch to sites.
- I am responsible for managing patient visit reconciliations, ensuring alignment with the CRF, budget, and site contracts. I create purchase orders (POs) for sites, manage corresponding invoices, and ensure timely payments, recording all data in the SAP system. Additionally, I oversee financial transactions related to clinical studies, including payments to ethics and research committees, patient reimbursements, and regulatory fees. I track invoices and ensure financial reconciliation with sites, maintaining precise control and regulatory compliance.
- Manage site contracts in sponsor CTM systems, handling amendments and budget modifications, and maintaining investigator fund trackers.
- Build and maintain strong relationships with study sites, interacting with clients to address payment-related issues and escalations, ensuring effective communication throughout the study lifecycle.
- Assist project managers with study planning, organization, and coordination, preparing detailed reports and escalating project risks as needed.
- Ensure project success by completing technical, logistical, and administrative tasks while maintaining updated procedures, guidelines, and documentation.
Sr. Accounting Assistant in Clinical Research
PRA Health Sciences
Colombia, Bogota D.C.
12.2014 - 06.2022
- Collected data from multiple sources to generate site payments according to documents and contracts.
- As the Treasury Lead, I manage and approve payments within the timelines outlined in project contracts, overseeing cash inflows and outflows to ensure efficient management of accounts receivable and payable. I prepare budgets, financial statements, and reconciliations, ensuring accuracy and the fulfillment of payment obligations to employees and vendors. I plan and supervise cash flow, manage investments, debt, and financial risks, consistently optimizing available resources and ensuring the financial success of projects.
- Processed investigator payments and managed expense reimbursements, including ethics committee fees, regulatory payments, site visits, credit notes, advance payments, or investigator meeting reimbursements.
- Created and entered budgets, worked on transparency reports, and conducted clinical study reconciliations.
- Facilitated effective budget negotiations with site staff in collaboration with key stakeholders.
- · Served as the primary liaison with the accounting outsourcing team, fostering collaboration to develop effective solutions and ensure alignment with financial goals.
- Provided audit updates on renewals, including risk-based renewals and future cost forecasting.
- Performed monthly closing activities, including bank reconciliations, advance reviews, and financial obligation reconciliation.
- Generated data to ensure accurate and timely accounting system entries for daily transactions.
- Implemented controls to manage financial resources efficiently and effectively.
- Reviewed and approved accounting adjustment notes and ensured proper oversight for financial operation collections.
Education
GOOD CLINICAL PRACTICE
The National Institute On Drug Abuse (NIDA)
05.2001 -
Specialization in Digital Transformation
The George Washington University
08-2022
Specialization Strategic Business Management
The George Washington University
10-2021
Phd Ol -Collaborative Work Teams
ADEN International Business School
05.2001 -
PhD OL - Talent Development
ADEN International Business School
05.2001 -
Specialization in Management Development
The George Washington University
01-2020
Bachelor of Science - Accountant
University Corporation Remington
Colombia, Colombia 05.2001 -
Skills
Good clinical practice
Clinical Trials Master File (TMF)
Informed consent process
Ethics committee submissions
Regulatory submissions
Teamwork and collaboration
Adaptability and flexibility
Organizational skills
Payment processing
Task prioritization
Work alone
Timeline
Sr. Clinical Trials Assistant
ReSolution Latin America
03.2024 - 01.2025
In-house CRA / Clinical Trials Assistant
PRA Health Sciences
01.2023 - 03.2024
Sr. Accounting Assistant in Clinical Research
PRA Health Sciences
12.2014 - 06.2022
GOOD CLINICAL PRACTICE
The National Institute On Drug Abuse (NIDA)
05.2001 -
Phd Ol -Collaborative Work Teams
ADEN International Business School
05.2001 -
PhD OL - Talent Development
ADEN International Business School
05.2001 -
Bachelor of Science - Accountant
University Corporation Remington
05.2001 -
Specialization in Digital Transformation
The George Washington University
Specialization Strategic Business Management
The George Washington University
Specialization in Management Development
The George Washington University