BUSRA ARSLAN ALMAZ

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability
• Responsible for the selection of study sites by assessing the site’s eligibility for a specific study (site selection visit planning, conduct, documentation and follow-up)
• Proactive site preparation and early identification of real site needs and issues
• Responsible for all site activities from feasibility to site close-out including but not limited to HREC, TGA, RGO submissions and approvals, contract and budget negotiations, ICF development, generation and collection of essential documents.
• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Conducted clinical trial in accordance with protocol and recorded and monitored progress.

CLINICAL RESEARCH PROJECTS

• Phase I-II Infection Diseases Trial | Blujay Therapeutics
• Phase III Vaccine Trial(GMO) | Arcturus Therapeutics (Unblinded CRA)
• Phase II. Cardiology Trial | Tectonic Therapeutics ( Feasibility SSU CRA)
• Phase III. Oncology Trial (Breast Cancer) | OBI Pharmaceuticals
• Phase I-II Haematology Trial | Ascenta Pharmaceuticals

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution
• May support the start-up phase
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) to verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate.

CLINICAL RESEARCH PROJECTS

• Phase II. Oncology Trial(AMG 510-Sotorasib) |Amgen
• Phase I. Paediatric Bone (Osteogenesis Imperfecta) Trial (AMG 795-Romosozumab) |Amgen
• Phase III. Dermatology Trial (AMG 451-Rocatinlimab) | Amgen
• Phase III. Adolesan Dermatology Trial (AMG-451-Rocatinlimab) | Amgen
• Phase III. Adolesan Rheumatology Trial (Apremilast) | Amgen

• Assisted in preparation of investigator-initiated protocols
• IRB submissions
• Assisted in research budgeting contracts
• Conducted clinical study visits by following strict protocol regulation, IRB mandates, Clinical monitoring requirements
• Facilitated FDA or TITCK-mandated quality control procedures and study audits.

CLINICAL RESEARCH PROJECTS

• Phase III. Nuclear Medicine-Urology Trial-Zircon Study |Telix Pharmaceutical
• Phase III. Radiology Trial-Sparkle Study | PRA health/Asealica Pharma
• Phase III. Gastroenterology Trial (M16-066) | AbbVie Pharmaceuticals
• Phase III. Gastroenterology Trial (M16-067) | AbbVie Pharmaceuticals
• Phase III. Haematology (Myelodysplastic Syndromes) Trial-Verona Study| AbbVie Pharmaceuticals
• Phase III. Haematology (Myelofibrosis) Trial- MANIFEST-2 | Constellation Pharmaceuticals

• Salvia samples preparation for qPCR
• PCR kit preparation
• PCR-Real Time PCR(qPCR).