Defined responsibilities within monipol for
phase I-IV trials
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Title/Function |
Abbreviation |
Main Responsibilities |
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Administrative
Director CBFK |
Admin Dir CBFK |
Administrative support and
technical maintenance of the facility. Purchase of services
and equipment.
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Administrative Trial Assistant |
ATA |
Administrative support of monipol staff
regarding Clinical Trial documents and filing. Translation
of selected Trial Documents.
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Archivist |
ARV |
Physical Archiving, Access
control to Archive and Room monitoring.
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Clinical Trial Assistant |
CTA |
Support of Trial Coordinator, preparation,
translation and Filing of Clinical Trial Documents.
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Clinical Research
Associate |
CRA |
Verification of Protocol
compliance of study conduction on-site, Source Data and Subject
Rights and Well-being.
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Control board and committee
for hospital infection
|
CB for Hospital infection |
The board and committee is responsible for
risk assessment in CBFK. |
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Director Clinical
Operations |
DCO |
Organisation and coordination
of Clinical Trials. Support of the clinical trial staff.
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Drug Safety Officer |
DSO |
Coordination, QC of AE reports and handling
and reporting of Adverse Events.
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Financial Director |
Fin Dir |
Contract Management. Responsible
for financial affairs according to legal requirements.
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General Manager |
GM |
Customer related processes, Contract Management,
Business development, budget responsibility. Establishment
and improvement of QMS.
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Head of Study
Nurses |
Head of SN |
Heading and supervision
of study nurses. Conduct of trial related procedures. Care
of Trial subjects.
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Human Resource Manager
|
HRN |
Contracts with monipol staff. |
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Investigator |
Inv |
Proper conduction of Clinical
Trial in accordance to Trial Protocol. Medical Care of subjects. |
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Laboratory Manager |
LM |
Proper handling and shipment of blood and
urine samples. Conduction of laboratory tests.
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Lead Clinical
Research Associate
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L-CRA |
Reporting of Status Monitoring
and Subjects, Supervision and Training of CRAs. |
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Logistic Manager |
LM |
Accountability of Trial Medication and Trial
Related materials within monipol, Printing of Trial documents,
Seminar Logistics.
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Medical Director
CBFK |
Med Dir CBFK |
Proper recruitment and
selection of trial subjects.
Proper conduction of Clinical
Trials Phase I and generation and documentation in compliance
with Protocol, GCP and the Polish law.
Proper delegation
of trial related duties.
Contract Management with Polish
Sponsors.
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Medical Director Phase II-IV |
Med Dir Phase II-IV |
Medical expertise within Clinical Trials.
Support of clinical trial staff and clinical site staff. |
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Pharmacist |
Pharm |
Delivery, retrieval and
destruction of Trial Medication and non trial specific medication. |
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Project Coordinator |
PC |
Project Management Phase II-IV, Reporting
of Project Status to Sponsor, Contact point for Sponsors,
Tracking of Clinical Trial Activities, maintenance of the
Clinical Trial Data Base and Set -up of Clinical Trials
in Poland .
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Project
Manager |
PM |
Organisation and coordination
of Clinical Trials according to protocol, Reporting of Trial
Status, Project Management Phase I.
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Quality
Manager |
QA |
Audits (internal, external), Maintenance
and improvement of monipol Quality Management System, GCP
Consultancy. Coordination and Supervision of SOPs.
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Security advisor |
SA |
Ensures that the security
requirements are properly communicated in accordance to legal
requirements.
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Study Nurse |
SN |
Conduct of trial related procedures. Maintenance
and check of study equipment.
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Trial Coordinator |
TC |
Set-up of Clinical Trials
(incl. site selection), Submission of trial documents to
Ethics Committees and Polish Authority (CEBK), maintenance
of Trial Master File, preparation of Investigator Trial
File and Pharmacy File.
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