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CMA familiarized during a clinical trial for avoiding problems and issues

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CRA positions increasing to expect an increase in Clinical Monitor Assistants for supporting and assisting a CRC. Maintaining a productive and smooth collaboration, Responsibility during inspections are able to maintain a productive collaboration with CRCs.

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									Are you a New Clinical Monitor Assistant (CMA)? Your Roles and
Responsibilities and Tips for Getting you Organized
This webinar will get you familiarized with the responsibilities of a CMA during a clinical trial, help you
get started and well organized, help you build up a healthy and productive collaboration within a
clinical trials team as well as suggest you tips for solving/avoiding problems and issues.


Description
Why Should You Attend:


        Are you a new Clinical Monitor Assistant (CMA)?
        Not new but looking for ways to get better organized and improve your collaboration with the
        team?
        Are you a new Clinical Research Associate who needs all the help you can get on your trials?


Watching the demand for Clinical Research Associate (CRA) positions increasing so rapidly, it is only
reasonable to expect an increase as well as in Clinical Monitor Assistants (CMAs) positions. This rapid
increase in CRC positions also increases the urgent need of well prepared and suitable assistants for
supporting and assisting a CRC.


This session is an important tool in preparing a CMA to be better organized. This training will outline
all the tasks and responsibilities of a CMA, how to get started, how to be able to maintain a healthy
and productive collaboration with the CRCs, suggest tips for helping you meet the deadlines and help
you solve any issues and/or problems of any kind that may come up on the way.


Areas Covered in the Seminar:


        The role of a CMA in a Clinical Trials Team.
        Tasks and responsibilities.
        Tips for getting better organized.
        Issues to solve/avoid.
        Maintain a productive and smooth collaboration with the team.
        Setting up and maintaining trial files.
        Responsibility during audits and inspections.


Who Will Benefit:


This webinar will provide valuable assistance to:


        People interested in setting up a Clinical Trials Team for exploring the field of Clinical Research
        New Clinical Monitor Assistants
        Clinical Monitor Assistants exploring possible new ways of getting organized
        Clinical Research Coordinators
        New Project Managers




Instructor Profile:


Katerina Theocharopoulou, is a Clinical Monitor Assistant (CMA). She started her career in the
Clinical Trials Area through Omega Mediation Hellas (later on named SIRO Clinpharm) on 2004 as a
CMA and Archive Coordinator, where she had the opportunity to collaborate with many Clinical
Research Coordinators on many different clinical trials and indications such as - Hyperlipidaemia
(phase IV study – 100 sites), Multiple Sclerosis (phase IIIB study – 5 sites), Neuropathitic Pain (30
sites), Benign Prostate Hyperplasia (phase III study – 17 sites), Sepsis (4 sites), HIV (phase IV study
– 14 sites), Breast and Renal Cancer (phase III study –10 sites), Neovascular age-related macular
degeneration (phase IV study – 8 sites), Schizophrenia (phase IV study – 50 sites), Erectile
Dysfunction (phase IV study – 50 sites), Hospital-acquired, ventilator-associated, or health-care-
associated pneumonia suspected or confirmed to be due to Gram-positive pathogens (phase II study –
8 sites), Epidemiological Cardio-Vascular Study in Primary Care (112 sites) – and many more.
Through her collaboration with SIRO Clinpharm was also given the opportunity to work at the
Oncology Clinical Trials Department of Novartis Hellas in the last 2.5 years as a CMA, as an unblinded
CRC but to also participate in the conduct of Compassionate Use Programs as well as in the handling
and monitoring of clinical trials drug for the department. Currently is seeking for new job opportunities
as she wants to explore other fields of Clinical Trials conduct and is collaborating with
ComplianceOnline for sharing her experience so far.


Topic Background:


The Clinical Monitor Assistant (CMA) is responsible for supporting the Clinical Research Coordinator
(CRC) during the conduct of clinical trials (using Good Clinical Practice (GCP)) in collaboration with the
CRC and under the supervision of the Project Manager. The CRC is responsible for the monitoring and
the smooth conduct of the trial, but for achieving that, he/she needs the support and assistance of a
willing, reliable, communicative and well organized CMA.


A CMA has a very important and difficult role within a Clinical Trials Team. Just to imagine that most
of the times he/she has to collaborate with 3 or many more CRCs and each one of them has more
than 1 trial of different phase – indication- duration and each one has his/her own way of working and
communicating therefore, too many different tasks to work on, too many different people to work
with.


A well organized and reliable CMA will provide the total support that each CRC needs during the
conduct of a clinical trial starting by the selection of sites to the preparation of Clinical Trial
Coordination File (CTC) after completion of the trial. Under a healthy and productive collaboration with
the CRC and always in accordance to the Good Clinical Practice and ICH guidelines, the CMA who has
the main responsibility for the set up and the maintenance of the trial files, will ensure as well, quality
work and organized files in case of any audits and/or inspections.

								
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