Anna Palenova Email & Phone Number

• Oversee the conduct of Phase I-IV clinical trials at designated sites;• Perform all types of the monitoring visits in accordance with the monitoring plan;• Build relationships with investigators and site staff;• Assure site adherence to GCP, ICH, project specific documents and applicable regulations;• Address and resolve issues at sites;• Collect and review project specific documentation, maintain and review TMF and ISF;• Review and verify CRF data, follow-up on CRF data entry, query status.

St Petersburg City, Russia

• Oversee the conduct of Phase I-IV clinical trials at designated sites;• Perform all types of the monitoring visits in accordance with the monitoring plan;• Build relationships with investigators and site staff;• Assure site adherence to GCP, ICH, project specific documents and applicable regulations;• Address and resolve issues at sites;• Collect and review project specific documentation, maintain and review TMF and ISF;• Review and verify CRF data, follow-up on CRF data entry, query status.

St Petersburg City, Russia

St Petersburg City, Russia

• Assisted in TMF maintenance and review;• Arranged IP, biosamples and study materials transportation and receipt;• Assisted in the organization and conduct of Phase I-III clinical trials by performing clinical trial documentation maintenance and communicating with investigational sites, vendors, and Sponsors;• Assisted PMs in preparing of project progress reports, project financial reports;• Supported CRAs on the monitoring visits conduct.

• Support of foreign colleagues with PEDP preparation, TMF filing and quality review (Germany, Austria, Switzerland)• Distribute, track, review, and approve individual site trial master file (TMF) essential documentation at project start• Collect, review, organize, and assemble regulatory submissions • Maintain timelines for study start-up submissions and all subsequent submissions• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements • Review pertinent regulations and guides to develop proactive solutions to clinical trial submissions issues and challenges• Collaborate with document center to ensure necessary documentation is present• Train and assist CRAs on the collection of essential documentation for the ongoing phase of the project

• Participated in the preparation and submission of documents and materials to the regulatory authorities for obtaining Clinical Trial Approval • Participated in the preparation and submission of documents and materials to the regulatory authorities for Investigational Product (IP) and Biosamples (BS) import and export license obtaining• Participated in the arrangement and coordination of IP and BS transfers, including import and export, and communication with warehouses• Arranged IP and study materials transportation and receipt• Organized study related documents • Assisted in the organization and conduct of Phase I-IV clinical trials by performing clinical trial documentation maintenance and communicating with investigational sites, vendors, and Sponsors• Assisted in the signing of the Clinical Trial Agreement • Supported the sites and medical monitor during studies• Carried out feasibility studies and communicated with investigational sites for participation in planned and ongoing trials

• Created and developed methods of biologically active substance synthesis, performing separation and purification• Analyzed results obtained using physicochemical methods• Performed literary and patent search of possible schemes and methods of substances obtaining

• Taught foreign medical students on Organic Chemistry in English by leading seminars and laboratory workshops

• Created and developed methods of biologically active substance synthesis, performing separation and purification• Analyzed results obtained using physicochemical methods• Performed literary and patent search of possible schemes and methods of substances obtaining• Assessed in biological activity in vitro and in vivo of substances obtained

Master'S Degree, Medicinal Chemistry, 5.0

Bachelor'S Degree, Chemical Technology Of Biologically Active Substances, 4.71

Specialist (Uncompleted), Public Relations, 5.0

Activities and Societies: Volunteering activities