Agata Tereszkiewicz

Kliknij, aby edytować informacje o stanowiskuRESPONSIBILITIES
• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.
• Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Under close supervision, 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 to Clinical Project Manager (CPM), CRS and/or line manager.
• Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Under close supervision, 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.

Kliknij, aby edytować informacje o stanowiskuResponsibilities:
• Updating and maintaining clinical systems that track site compliance and performance within project timelines;
• 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 completeness.
• Maintaining and performing reviews of electronic Trial Master Files;
• Creating, maintaining and performing review of Investigator’s Study Files;
• Coordination and performing payments for investigators and sites;
• Preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
• Perform assigned administrative tasks to support team members with clinical trial execution.
• Assist CRS, CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms, queries and clinical data flow.

LUXMED Diagnostyka Sp. Z o.o. - AVI Diagnostyka Obrazowa Clinical Research Coordinator Responsibilities:
• Responsibilities:
• Coordination of approximately 80 clinical trials, phases II, III, IV:
 Oncology (lung, breast, kidney, prostate cancer, melanoma, soft tissue sarcoma); multiple sclerosis; rheumatoid arthritis; autosomal dominant polycystic kidney disease; ankylosing spondylitis; Alzheimer’s disease; Etc.
• Being responsible to the Principal Investigator, Clinical Research Associate and Sub Investigators;
• Being responsible to review patients' medical history and report any changes in patients’ health during the course of a trial, in terms of medical imaging;
• Identify and report adverse events, Serious Adverse Events (SAEs) and other relevant patient events to the Principal Investigator or Sub Investigator in terms of medical imaging;
• Inform and instruct patients regarding preparations, medical imaging procedures and plausible side effects;
• Schedule study visits concerning CT/MRI within window as specified by the protocol;
• Confirm study visits one business day before patients' scheduled appointments;
• Arrange and determine staff or equipment availability;
• Organize space for study equipment and supplies;
• Review and respond to data queries in a timely manner;
• Complete, update and maintain documents for individual studies;
• Prepare study-related documentation such as Data Transmittal Forms, procedural manuals, Site Staff Training Logs, Imaging Capabilities Questionnaires, Patients; Visits Logs and so on;
• Ordering and maintaining study-specific supplies in terms of medical imaging;
• Liaise with Clinical Research Associates for monitoring visits;
• Preparing site to Sponsor’s visits as well as being the host;
• Following ICH, GCP and Declaration of Helsinki guidelines;
• Maintain up-to-date certificates of all scanners;
• Participation in Site Initiation Trainings as well as ensure that all site staff took part in it;
• Coding study data and Uploading images via Internet applications;
• Communication and cooperation with independent laboratories all over the World;
• Follow archiving procedures at end of study;