Being a non-medic in a clinical research team - your experiences?

groups » Training and Career Development » Being a non-medic in a clinical research team - your experiences?

• 850186 2 Feb 2024

  Thanx for sharing information

• Celine Monsur 30 Jan 2024

  Document controller

• Amira Elshenawy 21 Aug 2014

  Dear Hailarious,
  Thx for your concern. I am really sorry for my late response.
  1. I have graduated from the faculty of arts, English dept, but I've never been interested in literature, I am interested in the scientific and practical field. I participated as a document controller in the recent trial of Sovaldi for treating HCV .
  The experience of such trial supported me with great amount of knowledge in clinical research concepts. I feel I've become expert somehow in the pre, during, and post trials such as the processing of study documents duch as investigator brochure, its versions, study protocol and amendments if any, EC & IRB submissions, master file sections, forms such as AE , SAE, SUARS, AR, SAR...etc. The management of study files and correspondances.
  2. Actually, this is a hard to answer question. Really I am hopeless because I totally feel
  ack-of-all trades, master of none. I try to improve myself continually take courses and certificates, but non of staff appreciates my responsibilities they always exclude me to secretary title and concider my only duty is receiving and sending emails :( this image destroys me psycologically. But anyway I insist on improving myself regardless their look at me cause I adore this fruitful field.
  So I can't be ambitious, I just try hard to stay in this research site as a rare opportunity for me.
  3. I mean checklists that might facilitate managing the study documents and steps. I've edited one for receiving drug or lab kits shipment and another one for documents receipt and date of EC IRB submissions ...etc.
  If you can help me with anything it would be great.
  

• Hilarious de Jesus 11 Aug 2014

  Hi Amira,

  It's nice to see that a lot of support has already been given as a response to your query. For my bit, before I offer any advice, can I ask the following questions:

  1. Can you please enlighten me as to your background? You have already mentioned that you are the document trial controller for one of the studies you are involved with? Can you please elaborate about your educational and/or practical experience? This way, the advice can be given appropriate to your level of experience.

  2. Where do you see yourself in the short term (2 years) and long term (5-10 years)? This will also guide as to how to shape your career. Have you ever heard of the phrase "jack-of-all trades, master of none"? It's very important to slowly focus your career to the direction that you want it take.

  3. What are your immediate concerns and what resources do you think you would need to do this? I have noticed on your last post that you would need a checklist for your studies. What check list would you need? Do you mean the contents of a trial site file and a trial management file? Also, where do you practice? I am practising in the UK and I am well aware that the practice in the UK alone vary from country to country (i.e. Scotland vs England vs Northern Ireland) more so in other countries. Also, this documents are specified by legislation. Internationally, we follow the Declaration of Helsinki as the over arching principle in doing clinical trials/research studies (N.B. when I say clinical trial here, the definition can also vary from country to country and is dependent on the law). There is also the ICH-GCP but it is not as internationally binding as the Declaration of Helsinki.

  I hope that I did not confuse you and please don't be overwhelmed (as this is the most common reaction and I did too when I was starting in clinical research). Just take it in your stride and the Global Health community is here to offer support as you have seen from this post.

• AMIRA ELSHENAWY MUSTAFA 7 Aug 2014

  Thanks for your contributions.
  Would you please, recommend related websites and online courses other than this helpful one that would help me organize my duties, as we are conducting two trials at the same time starting in August 2014 in our research site. I am the document controller for both studies. I don't wanna commit any mistakes as possible, so am in bad need for helpful checklists & advice for organizing all these documents.
  

• FASELA EMMANUEL 22 Jul 2014

  
  Thankyou Augustine. I must say everybody has made valuable contributions!!

• AUGUSTINE ONYEAGHALA - Senior Contributor 16 Jul 2014

  Hi Amira,
  I have read through the contributions from colleagues within this forum and all made good points. I just add that you should not be discouraged on the ground that you do not have a medical background. Clinical research requires players with different professional background. No matter your education, to enter into the clinical research industry, everyone needs to learn the science, ethics, rules and regulations governing the industry. Identify what you love and make effort to develop your career along that line. your current responsibility is a good pointer that you should take courses in basic GCP and Data Management which are inevitable in clinical research operations. Many courses are available online which shall be helpful in developing your capacity in clinical research. I wish you all the best in future pursuit!

• Amira Elshenawy 9 Jul 2014

  Dear Dr. Glory,
  Thanks for your encouragement and valuable advice.
  I've just passes an online course on introduction to clinical trials and got certified.
  I am sooooo happy and i insisting on continuing my way to become A TRIALIST AND NOT A MEDIC as Morenike said.
  Thanks Morenike for your enthusiastic words.
  Do you recommend special online courses and certificates for me ???
  If you need any help in any study you are conducting, i am all yours for your help and for my practical experience.

• Morenike Ukpong - Senior Contributor, Regional Faculty Committee 8 Jul 2014

  Dear Amira,

  I am sure you have stayed a part of the clinical research team because you have something to offer. Every member of the team do not have to be Medics. There is a place for everyone. All you need is to build your capacity. For clinical trials, medics all have to build their capacity also. Continue to participate on the Global Trials dialogue. The update materials are also useful. take courses where you can find them and there you are: you grow into being a trialist and not a medic -:)

• Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead 7 Jul 2014

  Hello Amira,
  I see you are worried because you are a non-medic and have found yourself in a clinical research team where medical and research terminologies that you did not have a foundation in are daily used. This is a challenge but your passion, interest, openness and patience will overcome it. Sincerely, even for those with background in medicine or para-medical sciences, the clinical research language have to be acquired with similar passion as you are already expressing. So, don't feel isolated because there are even medics in your shoes. Going forward, you need to identify what actually fascinates you in clinical research and explore the various means of building your capacity in that area of interest. Global health network which you already belong to has a lot of useful e-learning materials. You can take free related courses on Coursera. National Institute of Health has valuable materials on Introduction to Clinical Research. You may apply for online certificate course on clinical trial by Johns Hopkins or London School of Tropical Medicine and Hygiene or other similar institutions. You will also need a mentor locally. Such a person may guide you as to what is obtainable on part time basis in your country. I hope this piece of information is useful. Finally, don't give up! I am Gbenga from Nigeria

• Amira Elshenawy 7 Jul 2014

  Dear Joby, Ali, Cody, All,
  Your words charged me with inthusiatic energy to stop givving up and go on. Actually, I am inrolled in a free course online entitled data management for clinical research. It's fruitful and enjoyable. Then I am registered in clinical terminology course, GCP and other one of research methodology.
  Do you recommend more courses for me? Or even online job vacancies in the field of clinical research even it's free just to practice and acquire experience?
  Thank you so much friends.

• The Editorial Team 7 Jul 2014

  Thanks everyone for your feedback on this interesting topic. I wanted to add that there are many roles within the research team that are absolutely vital and there's no need to be a medic to do them - ranging from data manager to project manager, trial coordinator, ethicists, community health workers, and all sorts of other roles. Research couldn't be done without people in these roles, and it's not necessary to be an MD. Have you discussed your feelings with your supervisor or team? Being a CTU, they should be able to support you in your career, whatever your role.
  You will also find lots of support and advice from the fantastic community on Global Health Trials as you've seen today and I hope this helps you too!
  I look forward to hearing from you
  The Editorial Team

• ALI Innocent 7 Jul 2014

  Hi Amira
  Many people around us here in Central Africa subregion have been where you are, and are today enjoying what they are doing, contributing in their small way to improving the lives of people through research. I will ask one of them to post an experience soon, so many others can be encouraged.

  I absolutely agree with Cody Reddy. Just to add that which ever course you are taking, please remember to sign up to the professional membership scheme on this online platform and a line manager will assist you through your passion and career development.

  Very best

• Joby George 7 Jul 2014

  Hii Amira,I'm joby George a Research nurse working in a tertiary hospital of India,
  Wonderful that you posted your query in one of the group where u can find out absolute solution because of the eminent professionals and research scholars in the network.

  With regard to your query,no need to get hopeless and helpless at this stage because you thought to get into one of the evergreen fields of medicine i.e clinical research.
  In my opinion there are lot many online courses are available in clinical research both paid and free,like the one coursera and as well as paid programs like James lind institute of clinical research,the one which is operating from india and well there be many other of paid ones.Its the matter of ur choice that you want to get into which role of clinical research ,either you start from basic research methodological courses and soon you develop the research skills you can either choose data management which is one of the key role involved in clinical research industry and after your mindset changes i mean after you get a detailed idea about research skills,you can very well move into document controller,but at this point of time.I prefere you to move ahead with basic research course which you can pursue online,or by reading books or through web searches at the same time you can do your job too and thereby you can update both professional and research skills.I hope my suggestions will motivate and enable to take a decision soon.

  I would like to reiterate one of the famous quote"Allow your passion to become your purpose and it will become one day becomes your profession"

  Wishing u all the very best.

  Regards,

  Joby George,RN India.

• Cordelia Leisegang - Regional Faculty Lead 7 Jul 2014

  Hi Amira,

  I think the first place to start if you would like to do something medical, is to identify which parts of the clinical work you enjoy and are interested in studying further. Once you get a feel for what it is that you enjoy most, I suggest that you speak to those professionals within your team who are already in this field and ask their advice about whether they feel it would be possible to study part-time. The challenge of studying something in the medical field, is that it is often not possible to study part-time.

  You could study for a Social Science/Public Administration/Public Health qualification,and selectively choose courses which have a medical component, logistically this maybe easier for you to do part-time. The document controller is an essential part of any clinical trial team and it maybe worth your time, investing in developing yourself in the area you are in already, with the qualifications suggested above.

  Good luck.