Joanna Opyrchał

Assist Clinical Operations Manager (COM), Project Manager (PM) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and
performance within project timelines.

Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.

Document Management and Tracking (including the CTMS system), including Set-Up and maintenance of all sections of the Trial Master Files (Core Files, Country Files, Sites Files).

Set-up, maintain and manage TMF in collaboration with the COM/PM/CRAs.

Assist COM/PM/CRAs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.

Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Create and maintain designated trial tracking tools in accordance with trial requirements (e.g. Essential Documents, Site and Vendor Activities, Monitoring Visit Reports, Trial Budget).

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

Prepare, distribute and file agenda, minutes and meeting materials as required, draft and/or assist with the preparation of trial-related documents, tools and templates, including newsletters.

May perform assigned administrative tasks to support team members with clinical trial execution.

Assist in preparing Ethics Committees/Regulatory submissions, communicating with the ECs and managing of further EC-related documentations.

Continuous interactive co-operation with other Brillance, Sponsor or Sites staffs to co-ordinate successfully study preparation, conduct and close-out fulfilling all applicable global and local or contracted requirements.

Administration of clinical research center
Preparation of source documentation
Coordinating and dispatching essential trial documents
Verification of documents according to protocol and Good Clinical Practice
Comunication with CRO during qualification and initiation of the trial
Cooperation with Clinical Monitors, Data Management, Medical Monitors and Sponsor Representatives during trial
Updating appropriate tracking systems
Close-out and archivization responsibilities
Central and local laboratories comunication (supply, sampling, shipment, certification)
Patients visits scheduling
Subjects accounts and questionnaires management - ERT, TrialMax
Investigational Product administration
Data entry in paper or electronic CRFs
Data transmision and management - Qmetrics
IVRS/IWRS handling
Preparation of agreements between local institutions (hospitals, laboratories, medical devices administrators: RTG, MRI)
Participation in global conference calls and meetings to prepare for upcoming or review progress of ongoing clinical trials
Preparation of the site to audits and inspection