What is Clinical Trial Administrator Part-2

Hello people this post is the extension of what is CTA (Clinical Trial Administrator) part-1. In part-1 we covered who is CTA, what are educational requirements and working conditions. Here I would like to further discuss about additional qualifications required for CTA, career growth and key terms need to know by CTA at their job.

Learning objectives from part-1 and part-2 of what is CTA:

1. You should know what is CTA?
2. Where CTA job involves in the clinical trials
3. What educational requirements needed to become a CTA?
4. How CTA career development would be?

Educational Qualifications:

In most of the cases Pharmaceutical or CRO's companies will prefer to hire life science graduates with the prior knowledge of conducting clinical trials. After hiring new people, companies will provide ''on-the-job'' training, which is the most effective means of training. Here employer will give practical training on material, documents and software's etc..that trainee will use after fully trained in their regular job activities.

Few companies along with giving ''on-the-job'' training will follows the structural internal training courses which will give additional knowledge over regular training. 

External training: 

Apart from the above mentioned structured training, academic qualifications in clinical trial management like: Post-graduate Certificates (PgCert), Diplomas (PgDip) and an MSc degree in Clinical Research gives additional knowledge and improves the chances of getting successful in interview. 

Skills required:

Here I would like to discuss few additional skills required to get the job and survive in the job...:)

1. Good organisational skills
2. Time management and prioritization of tasks
3. Able to work in team without any grudge.
4. Attention to detail 
5. Flexibility at work as it required very frequently in clinical trials.
6. Good interpersonal skills and IT skills. 

Experience:

• By working as a CTA you will get the following experience:
• Knowledge of planning, performing and organizing clinical trials.
• Clinical trials performance in accordance to GCP (Good clinical practices) and ICH GCP (International conference on Harmonization of Good clinical practices)
• Legal requirements associated with clinical trails in different countries.
• Executing good administrative role in pharmaceutical industry. 
• Record management knowledge of clinical trial data of life-cycle of study from setting up of study to concluding the study.

Career progression: 

Entry level:

At the entry level career CTA role involves in assisting to other clinical team members in administration tasks relevant to clinical trials conferring to GCP and companies regulations.

Functions include:

1. Developing documents related to clinical trials
2. Tracking patients sample and Case Report Forms (CRF)
3. Maintaining electronic trial master file (e-TMF)
4. Supporting clinical research associates and visitng to sites with them
5. Arranging internal and external meetings.
6. Dealing with suspected unexpected serious adverse reaction (SUSAR) notifications. In few cases companies may appoint specific SUSAR administratiors who delas these notifications in parallel with CTA's
7. Preparing and sending study material to investigator sites.
8. Assisting in maintenance of udated contact list includes: CRA's , data managers, investigation sites, study managers.

Progression in career:

Getting good experience in entry level, leads the progression in career towards more senior CTA. This senior level position gives more responsibility in-terms of supervising the CTA team and managing study. The senior CTA further progress towards to the CTA manager position in the company. In some cases this order of progression may be slightly differ based on the company. Few people like to be remain as CTA in their career these can be termed as career CTA. 

At the senior positions some of the functions include:

• Tracking and distributuion of study protocols and their amendments.
• Maintaing TMF's and essential documents according to ICH GCP compliance.
• Tracking distribution and destruction of Investigator Brochures (IB)
• Coordinating ethics and regulatory submissions relevant to clinical study.

How could I find CTA job??? 

(1) Advertisements in recruitment agencies
(2) Attending to recruitment fairs.
(3) Contacting and networking with people who are already working in pharmaceutical or CRO's
(4) Applying at company websites...it is very little successful...:(
(5) Internal vacancies in the company.


Useful organisations and websites:
http://www.abpi.org.uk/
http://www.acdm.org.uk/
http://www.barqa.com/cms.php?pageid=390&index=1
http://www.corec.org.uk/
http://www.efpia.org/Content/Default.asp
http://www.mrc.ac.uk/index.htm
http://www.dh.gov.uk/en/index.htm
http://www.topra.org/


Please feel free to give your feedback....that really helpful - Thank you


With regards,
Santhosh rao mennani

Posted in: Career paths