Sara Ghaderi

I have been responsible to ensure that all sites are fully prepared to meet regulatory requirements and operational standards. This role involves coordinating site preparations, managing regulatory compliance, and overseeing the implementation of procedures to ensure smooth and compliant operations. The Specialist works closely with various internal and external stakeholders to facilitate site readiness for new projects, audits, inspections, and ongoing operations.

• Negotiate and finalize contracts with study sites, including budget agreements and service terms
• Ensure all necessary site modifications and upgrades are completed according to project specifications and timelinesEnhanced regulatory compliance by developing and implementing robust policies and procedures.
• Worked closely with legal counsel to address any concerns related to noncompliance or regulatory investigations.
• Collaborated with cross-functional teams to ensure successful product launches in line with relevant regulations.
• Prioritized project-related tasks to efficiently complete essential tasks.

• Coordinating preparation and submission of regulatory documents, including Investigational New Drug (IND) applications and Ethics Committee/Institutional Review Board (EC/IRB) submissions. Managing site CTRA and CDA
• Liaising with study sites to ensure that all regulatory and contractual documents are completed and submitted in timely manner.
• Developing and maintaining study site feasibility and selection processes.
• Ensuring that all trial‐related activities are conducted in compliance with company standard operating procedures (SOPs), ICH‐GCP guidelines, and other relevant regulations and guidelines. Communicating with study teams and stakeholders to provide regular updates on status of trial start‐up activities.

• Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.
• Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
• Evaluated potential subject participants to assess suitability for planned studies.
• Planned, modified and executed research techniques, procedures and tests.
• Assessed data using scientific methods while following important specifications.
• Developed macros, special formulas and other actions to produce reliable and consistent statistical reviews.
• Supported lab activities by maintaining inventory and chemical stocks and cleaning lab equipment.

• Compared laboratory data against specifications to determine if results met requirements.
• Recorded test results on standardized forms to enter into database and communicate to appropriate personnel.
• Prepared reagents and solutions, calibrating pipettes and related activities to support experiments. Conferred with management and other laboratory staff to develop understanding of product References available on request.
• Leveraged personal protective equipment to maintain safety in lab.
• Followed method or standard instructions and adhered to internal SOPs to eliminate repeat testing, deviations and investigations.
• Fulfilled lab assistant or specimen processor duties to support work of technicians, technologists and scientists
• Collaborated with team members to successfully complete project work due in 2 weeks.
• Set up, maintained and verified sterility of lab equipment and tools.
• Identified microorganisms present in stool samples and cultivated