Alejandrina Aldana

• Enhanced business operations by implementing efficient management strategies and streamlining processes.
• Increased overall profitability by identifying cost-saving measures and optimizing resource allocation.
• Developed a strong company culture, fostering teamwork and collaboration among staff members.
• Implemented innovative marketing campaigns to expand customer base and increase brand awareness.
• Oversaw financial management tasks, including budgeting, forecasting, and cash flow optimization.
• Mentored employees to improve work performance, promoting professional development and growth within the company.
• Improved customer satisfaction ratings by consistently delivering high-quality products and services.
• Managed day-to-day operations efficiently, ensuring smooth workflow and timely completion of tasks.
• Evaluated market trends to identify new revenue streams and diversify product offerings accordingly.
• Implemented regular performance reviews for staff members to address concerns proactively and provide constructive feedback for continuous improvement.
• Ensured accurate record-keeping for financial transactions, maintaining organized documentation for easy reference during audits or other inquiries.
• Cultivated a safe working environment by adhering to workplace safety policies and providing necessary resources for employee wellbeing.
• Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
• Trained new employees on proper protocols and customer service standards.

• Responsible for drafting, negotiating and finalizing contracts and other relevant legal documents as they relate to various clinical projects.
• Independently negotiate proposed changes to standard contract language within guidelines provided by the Legal Department; raises significant requested changes to standard contract language to the Legal Department and significant budget exceptions to the appropriate management for consideration.
• Determine potential needs for contract amendments and manage amendment execution.
• Establish master agreements with frequently used sites.
• Reviews Informed Consent Form for consistency with contract language.
• Proactively keep study team informed of the negotiation status.
• Ensures study budgets are drafted and prepared within fair market value standards.
• Develop and maintain contract templates in accordance with changes in laws or regulations.
• Track contract process metrics to reduce negotiation cycle time.

Liaise and oversight of contract research organizations (CRO):

• Good Clinical Practices (GCP) compliance (e.g., review of monitoring reports, notes to file)
• Review CRO/site communications (e.g., newsletters, clinical bulletins)
• Budget tracking/expense management
• Review of project management status reporting
• Manages the entire clinical study process through to publication and executes clinical research projects and clinical trials; includes clinical study plan, protocol development, contracting, auditing and monitoring, data collection activities and close-out activities and ensure efficient and timely processing of confidentiality agreements and clinical agreements.
• Monitors progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
• Provides support in start-up, enrollment, follow up and closure of clinical trial activities
• Ensured operational aspects of the studies are being conducted in accordance with all relevant ethical and government standards, GCPs, and Avita’s Standard Operating Procedures.
• Liaise between the sites and the Department of Defense (DoD)/Human Research Protection Office (HRPO)

Management of the clinical regulatory study files:

• Supervise collection and filing of current clinical study regulatory documents
• Maintain audit-ready central study files
• Liaise with CRO/clinical monitors to close gaps

Management of the research contracts and finance:

• Develop contract language for studies
• Develop preliminary study budgets
• Lead negotiation and execution of agreements (research agreements, clinical trial agreements, consulting agreements, confidentiality agreements)
• Manage study and other contract payments and accruals, as needed
• Manage incoming DoD grant/contract funding
• Maintain audit-ready financial records
• Associated financial reporting
• Track study expenses versus budget
• Manage payments to contractors of the R&D group
• Develop and maintain clinical research operating procedures.
• Conduct various internal audit functions, as required.

• Responsible for drafting, negotiating and finalizing contracts and other relevant legal documents as they relate to various clinical projects.
• Independently negotiate proposed changes to standard contract language within guidelines provided by the Legal Department; raises significant requested changes to standard contract language to the Legal Department and significant budget exceptions to the appropriate management for consideration.
• Determine potential needs for contract amendments and manage amendment execution.
• Establish master agreements with frequently used sites.
• Reviews Informed Consent Form for consistency with contract language.
• Proactively keep study team informed of the negotiation status.
• Ensures study budgets are drafted and prepared within fair market value standards.
• Develop and maintain contract templates in accordance with changes in laws or regulations.
• Track contract process metrics to reduce negotiation cycle time.

• Responsible for drafting, negotiating and finalizing contracts and other relevant legal documents as they relate to various clinical projects.
• Independently negotiated proposed changes to standard contract language within guidelines provided by the Legal Department; raised significant requested changes to standard contract language to the Legal Department and significant budget exceptions to the appropriate management for consideration.
• Determined potential needs for contract amendments and manage amendment execution.
• Established master agreements with frequently used sites.
• Reviewed Informed Consent Form for consistency with contract language.
• Proactively kept study team informed of status of contracts and IRB submissions.
• Managed quality control of payments to ensure they comply with relevant contract terms and are paid in accordance with budget guidelines.
• Maintained an ongoing payment and regulatory tracking system.
• Reviewed general ledger to ensure all departmental expenses are properly reported and posted.
• Tracked contract expenses and conduct financial analysis in support of forecasting process.
• Contributed to the development and review of departmental and standard operating procedures.

• Drafted and negotiated clinical trial agreements, amendments, non-disclosure agreements, and budgets with clinical sites.
• Directly negotiated proposed changes to standard contract language within guidelines provided by the Legal Department; raises significant requested changes to standard contract language to the Legal Department and significant budget exceptions to the appropriate management for consideration.
• Proactively kept study team informed of status of contracts.
• Managed quality control of payments to ensure they comply with relevant contract terms and are paid in accordance with budget guidelines.
• Maintained an ongoing payment and regulatory tracking system.
• Reviews general ledger to ensure all departmental expenses are properly reported and posted.
• Tracked contract expenses and conduct financial analysis in support of forecasting process.
• Contributed to the development and review of departmental and standard operating procedures.

• In-house study site management support: investigator recruitment, budget and contract negotiation, regulatory document collection and maintenance and tracking, distribution of clinical supplies and study tools, responded to questions from sites, maintained in-house master files.
• On-site study site management support: training of site staff, site visits, source data verification, trip report generation, correspondence.
• Study/clinical supply management: verification of proper storage, reconciliation of supplies
• SAE reporting according to all applicable laws and regulations
• Assisted in the development of study related documents such as study protocol, CRF, guidelines, monitoring tools
• Managed quality control of payments to ensure they comply with relevant contract terms and are paid in accordance with budget guidelines.
• Tracked contract expenses and conducted financial analysis in support of forecasting process.
• Contributed to the development and review of departmental and standard operating procedures.

• Ensured accurate and timely collection of all essential regulatory documents. Audited internal regulatory documents obtained from clinical sites.
• Implemented and maintained an ongoing regulatory tracking system.
• Managed quality control of payments to ensure they comply with relevant contractual terms and are paid in accordance with budgetary guidelines.
• Organized meetings for investigators, study coordinators and field personnel including travel and meeting logistics as necessary.
• Ensured accurate inventory accountability of investigative devices.
• Contributed to ongoing departmental and project-specific process improvement efforts.