Sekinat A.

• Conducted onsite monitoring visits (Pre-Study, Initiation, Interim, and Close-Out) to ensure Facilities are adequate Investigative site staff are adequately qualified Site activities follow clinical trial protocol and applicable regulations
• Analyzed monitoring metrics to identify issues proactively and improve efficiency and performance
• Conducted site evaluations, initiations, and close-out visits as needed
• Assessed performance of assigned CRAs
• Contributed to organizational improvement within Clinical Operations and monitoring
• Collaborated with Clinical Trial Managers to implement clinical study plans and manage monitoring resources
• Managed resource projections across clinical trials to meet milestones and deliverables
• Communicated regularly with investigative site staff and documented correspondence as required
• Reviewed regulatory documentation/files for completeness and collected updated forms as necessary
• Trained investigative site staff as needed
• Provided regular updates to project managers on site status (e.g., screening, enrollment)

Responsible for all aspects of study site monitoring, including pre-study and initiation visits, routine monitoring, closeout visits, and continuous maintenance of Investigator/Site Files.

-Ensured that the study staff who would conduct the protocol had received proper materials and instructions to enter patients into the study safely.

-Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are performed according to the applicable regulatory requirements. -Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. -Ensured that the resources of the Client and Accelovance were spent wisely by efficiently performing the required monitoring tasks, according to SOPs and established guidelines,including economically managing travel expenses according to Accelovance’s travel policy. -Ensured implementation of all other assigned responsibilities/activities described in -Project Monitoring Plans, Project Communication plans, and other project-specific documents.

-Ensured that all issues, deviations, and violations were escalated to the ProjectManager/Project Lead.

-Supervised Serious Adverse Event (SAE) reporting process on all stages, including preparing the report, narratives, and follow-up of SAEs in assigned sites. Performed CRF review; query generation, and resolution against established data review guidelines on Accelovance or client data management systems in assigned studies.

-Undertook feasibility work when assigned by Line Manager. -Maintained quality control of assigned parts of Trial Master File (incl. site-related documentation) Assisted with training and development of new employees,

-performed co-monitoring visits, provided assistance in monitoring in other sites. Participated in teleconferences and meetings with Client or/and study staff

-Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.

-Ensured timely completion of all deliverables by tracking project timelines and milestones.

-Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.

Prepared reports summarizing study progress and results for senior management review.

-Participated in internal audits related to clinical research operations processes.

• Provided support for all aspects of the clinical trial process including recruitment, data collection, and closeout activities.
• Responded promptly to queries from investigators regarding protocol procedures or other issues related to the conduct of a clinical trial.
• Monitored drug supplies at investigative sites to ensure adequate supply throughout the duration of the trial.
• Maintained regulatory documents such as informed consent forms and investigator brochures.
• Collaborated with CRA on site issues/actions.
• Reviewed recruitment plan and enrollment updates and addressed/resolved issues pending from the previous visit.
• Communicated effectively with external stakeholders such as sponsors, CROs, vendors.
• Performed regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS, ISIS).

• Leads efforts and responsible for planning, conducting, and documenting assigned Change Request (CR), Change Design Document (CDD) and Test Script following the Change Management processes
• Work with the leadership team to understand organization’s vision and objectives and develop strategic plan
• Work with both functional and technical team to support end users on the SAP application’s integration and functionality
• Reviewed and determined those technology deficiencies that can potentially affect the functional area’s ability to support or meet the organizational goals
• Manage implementation of programs, including the delivery of business solution on time, within budget and acceptable quality
• Reviewing the design and operating effectiveness of SAP with external auditors ensure business requirement are complaint and adheres to the Federal Compliance guidelines affecting Laws, Regulations, and Policies (LRPs)
• Documenting the compliance team process and procedures within the LMP program
• Proficient in using the HP Application Lifecycle Management tool (HPALM/HPQC) for test planning, requirements management, defect reporting and tests tracking.