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Survey: Site and Study Team Issues
Author:  Anonymous Medzilla Reader
Date:  06-16-12 07:12pm
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I wanted to bring up a few issues that I've noticed that have increased in the last few years as monitor. I want to know if others have experienced the same issues.

1. Are you all finding that sites are getting more difficult to work with such as updating training/delegations logs (reg docs), scheduling visits, source documentation, queries, etc...

2. Trip reports becoming more lengthy, not given much time to complete them, more questons, and comments

3. Budget and expenses: requiring boarding passes, slow processing

4. Insufficient training

5. Poor, inadequate, slow IT systems
 
 
  Author: Anonymous Medzilla Reader Feb 16, 2017, 07:38AM
 
    Re: Survey: Site and Study Team Issues   Log In to Report Post
 
   thanks
 
 
 
  Author: Anonymous Medzilla Reader Feb 24, 2014, 05:23PM
 
    Re: Survey: Site and Study Team Issues   Log In to Report Post
 
   How long have you been monitoring? Monitoring is a tough job, every company has its quirks and things they really keep the eye on. 1. Are you all finding that sites are getting more difficult to work with such as updating training/delegations logs (reg docs), scheduling visits, source documentation, queries, etc...No every site is different and need different motivational tools to get their job done. If your site isnt getting the job done make sure the PI is aware. 2. Trip reports becoming more lengthy, not given much time to complete them, more questons, and commentsReally - checklist questions should make your reports easy to finish. Write the report on site I have mine finished w/in 5 working days. I review these each week and they are easy as long as you stick to facts and dont write more than than needed. Short and concise. If your reviewer is asking for more than you think is necessary - tell them.3. Budget and expenses: requiring boarding passes, slow processingReally - this isnt that big a deal. Get a report done every Friday/Monday which ever is best - you need to make sure you have one office day a week, if you dont, maybe you should get your CV out to the recruiters.4. Insufficient training - for your or for your sites? If you dont feel like you are adequately trained then there is nobody to blame but yourself for not making sure you are up to speed.5. Poor, inadequate, slow IT systems - check your ISP see if you can get faster service, maybe its on your end if you home office.
 
 
 
  Author: 3:27 Aug 01, 2012, 10:55AM
 
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   4:25 : You would think it's common sense to read the protocol; however, one of the biggest problems I've been running into is CRCs following the source docs or 'cheat sheets' on how to do a visit and end up causing a lot of deviations because they miss the nuances of the protocol.
 
 
 
  Author: Anonymous Medzilla Reader Jul 31, 2012, 04:25AM
 
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   To:3:27 PM: I'm sure everyone knows to read the protocol. The IM is a great environment to ask questions and review situations you may have not thought of before.
 
 

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  Author: Anonymous Medzilla Reader Jul 28, 2012, 03:27PM
 
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   Training at an IM is a great supplement to reading the protocol, but it is NEVER a substitute for a comprehensive reading of the protocol. So many times I've ran into problems because people fail to actually read the protocol and just rely on what someone said.
 
 
 
  Author: Anonymous Medzilla Reader Jul 12, 2012, 01:49PM
 
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   I hate to disagree, but the best training is an in-person IM. The best one I ever went to was one where the study team walked everyone through a subject from screening to study end. It was so much better than someone just reading the protocol to you. In-person IMs give the investigators a change to talk to each other, exchange ideas, and to bring forth questions that might otherwise never come up. Nuances in the protocol can be explained right then and there...not six months after the first subject has been enrolled. I realize it's an expensive proposition, but you get what you pay for.
 
 
 
  Author: CRA MBA Jul 12, 2012, 11:21AM
 
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   I am finding the same issues, however only a few of my sites are not compliant or fail to train. I do believe as an industry there is a rush to get sites to enroll and they are not quite ready.
 
 
 
  Author: Anonymous Medzilla Reader Jul 12, 2012, 08:56AM
 
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   1.Just like CRAs, site staff is to dealing with "churn & burn". The problem is that, as a CRA you have a job to do. This is where critical thinking and problem solving is a must. Consider yourself as a member of the site team. Work with them as a team. I have taken some training with the web site "Mind Tools". Dont expect your CRO will help you with these skills.
2.Trip Reports-there is no cure for this issue. We write reports for the reviewer, not the sponsor. If you have different reviewers, you will never get your reports approved on the first draft. The best I can offer is that you can have one reviewer for your reports.
3.Expenses are a conundrum. I have had to provide boarding passes, I have worked on per diem, I have had to provide all receipts (even the receipt for a $0.10 toll), in some cases, I needed to provide expenses for anything over $25.00. What doesnt make sense is that they all claim this is what the IRS needs. Huh? If all CROs are working with the same IRS, why are they so different? While I dont understand it, and it is a nuisance, I just do what they ask so I can focus on the project.
4.As for training, the CRA has to take the initiative to be informed. The issue is to get a well written protocol. I just came off a study with the worst protocol ever. It is no wonder this study had to close early. I am a scientist, a molecular biologist who worked on the bench in pharma. When I jumped to the clinical side, I took a job as a coordinator. I spent long hours learning about the disease state. I also took a graduate course in clinical research. I joined ACRP and SoCRA and became certified in both. You have to invest in your career.
5.We depend on IT to get our job done. Sadly, the CRA usually takes a beating when IT does not get the job done. For CRAs who are home based, efficient IT is essential but does not exist. It is sad the in most cases CRAs take the hit in the blame game for why things cant get done. My post is too long to go into my IT horror stories. If management were more involved in serving the client, maybe things would change. The CRA will remain the victim.
 
 
 
  Author: Anonymous Medzilla Reader Jul 11, 2012, 07:29AM
 
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   When it comes to training, that responsibility lies 90% on the individual. No one can read the protocol, monitoring plan, user manuals, etc (all cover to cover of course) for you. No one should rely soley on investigator meetings or training sessions for training. The people that rely on others for training are typically the most uniformed people on the study and it's 100% their fault because they don't put the work in themselves.

. I think it's strange how 8:02 replies to 5:26 saying they've monitored for many more years than them; however, 5:26 never stated their experience level. These assumptions are unnecessary. Additionally, we all know that the number of years we've monitored is NOT an indicator of quality and experience over ten years old is rarely relevant to current market conditions.
 
 

Fill that difficult position NOW

 
 
  Author: Anonymous Medzilla Reader Jul 10, 2012, 07:56PM
 
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   Well I have been monitoring for almost 10 years. I have been on fantastic studies that were well-run with well-chosen, enthusiastic, and engaged sites. Then I have been on studies that were a nightmare all around and the FDA should have been called. Bottom line is that the study team, including the sponsor if CRO-run, sets the tone for the entire project from the get-go. Well-run studies should have appropriately chosen, experienced, and well-trained sites, a well-written and thoughful protocol with minimal amendments, and an in-house staff that is supportive to the field staff. This has become the exception rather than the rule, unfortunately. Right now I'm dealing with a study that has minimal worldwide enrollment, multiple amendments because the protocol was extremely poorly written, sites who were absolutely inappropriate and inexperienced for this type of study, and a sponsor with too many people sitting around doing nothing except finding things to nitpick and making extra work so they can justify their jobs. The CRO is more concerned with keeping their cash cow and keeping the sponsor happy that they refuse to discuss these issues with the sponsor. If you have wonderful studies with wonderful sponsors and wonderful sites, consider yourself lucky.
 
 
 
  Author: Anonymous Medzilla Reader Jul 09, 2012, 08:02AM
 
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   I am replying back, I am the 5:26 poster.

I have been doing this line of work many years, longer than you have. I have worked for CROs and sponsor directly, currently I am with a sponsor company.

Yes, sites have turn over and issues, CRAs turn over all the time as well. The fact is it is a hard job, but no harder than diggin a ditch.

again, dont blame anyone but yourself if you dont feel adequately trained.

if your sites are non-compliant get them compliant.

Bottom line - speak up, get it done and be done.
 
 
 
  Author: 1:58 Jul 05, 2012, 11:18AM
 
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   Hello 6:55pm,
I am the 1:58pm poster and your assumption is incorrect. I have been working as a CRA for over 6 years now for a few different companies and I'd hardly call it a dream world. I haven't had any overarching issues getting logs updated, scheduling visits or getting items resolved. Of course there's always 'that site' who has a plethora of problems, but if you are noticing that a majority of these sites are giving you difficulty getting the basics done, perhaps it's not the sites' problem- it could be what or how it's being asked by you. That seems more like the common denominator to me.

If I had to put an estimate on it, I would say 75% of my sites are cooperative and flexible, 20% give me an issue on occasion and I'd only describe 5% as being 'uncooperative' or disinterested in the quality of their work. 5:26 brought up a good point that you have to use different techniques with each site to be successful and what worked 5 years ago may not be the same technique that works today.
 
 
 
  Author: Anonymous Medzilla Reader Jul 04, 2012, 06:55PM
 
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   @5:26 and 1:58...you two are living in a dream world and/or have never worked for anyone besides your current employer and/or you are not actually a CRA. The OP is absolutely correct. This job is definitely not the same as when I first started many, many years ago. #1 is the biggest issue. Sites are overworked and turnover at the sites is horrendous. No one wants to do anything, the PIs don't care, and the CRO doesn't want to get the sponsor involved. The main problem is that study start-up at the site level is not being properly performed...study start-up is rushed and so many things overlooked that should be in place prior to start of enrollment. I've never been asked for a boarding pass...not sure what that would prove. Training is nearly non-existent in most cases. I have not been sufficiently trained on any study in a long, long time...no one has time, and no one cares. I find I am training myself more often than not. I don't take any pharmaceutical products I don't absolutely need...there is a reason for that!
 
 
 
  Author: Anonymous Medzilla Reader Jun 25, 2012, 05:26PM
 
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   How long have you been monitoring? Monitoring is a tough job, every company has its quirks and things they really keep the eye on.
1. Are you all finding that sites are getting more difficult to work with such as updating training/delegations logs (reg docs), scheduling visits, source documentation, queries, etc...
No every site is different and need different motivational tools to get their job done. If your site isnt getting the job done make sure the PI is aware.

2. Trip reports becoming more lengthy, not given much time to complete them, more questons, and comments
Really - checklist questions should make your reports easy to finish. Write the report on site I have mine finished w/in 5 working days. I review these each week and they are easy as long as you stick to facts and dont write more than than needed. Short and concise. If your reviewer is asking for more than you think is necessary - tell them.

3. Budget and expenses: requiring boarding passes, slow processing
Really - this isnt that big a deal. Get a report done every Friday/Monday which ever is best - you need to make sure you have one office day a week, if you dont, maybe you should get your CV out to the recruiters.

4. Insufficient training - for your or for your sites? If you dont feel like you are adequately trained then there is nobody to blame but yourself for not making sure you are up to speed.

5. Poor, inadequate, slow IT systems - check your ISP see if you can get faster service, maybe its on your end if you home office.
 
 

Post Jobs - get great candidates!

 
 
  Author: CRA Wannabee... Jun 19, 2012, 10:16PM
 
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   Am now a CRA.

@ Jun 17, 2012,

For which company do you work?
 
 
 
  Author: Anonymous Medzilla Reader Jun 17, 2012, 08:08PM
 
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   Yes, and it's worse with CRO's. I was working for a small company bought by a big company who doesn't have CRAs and uses CROs so I went to a small one. Wrong. I went from 8-10 sites to 18 sites! Is this a life?
 
 
 
  Author: Anonymous Medzilla Reader Jun 18, 2012, 08:35AM
 
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   1. Sites are being asked to do more and have undergone their own cutbacks/changes in the past 3 years especially. Repetitive data queries (DCFs) frustrate sites and that is one area where companies can improve.

2. Tripreports are being used as data collection tools, which is not a proper use of the report. The report needs to track issue identification, resolution and escalation, but should point the reader to an internal tracking system for each project.

3. Confirm with your company that if expense reports are in by say Friday that they can be processed within 1 week, by the following Friday. No reason why your expense reports should not be processed as promptly as an internal CRA's reports.

4. CRAs coming onto a project during the trial deserve to be and are 'required' to be trained to the same standard as those CRAs who started the trial. Anything else is setting up a study for failure.

5. IT and Clinical need to have an interface, a person who can make technology work for the Clinical teams, as well as make suggestions to IT for streamlining processes, databases, data collection tools, etc. If a company does not maintain their IT investment, it is a recipe for clients to not use those services. Any company has to have an annual or an ongoing IT/Data Mgmt/Clinical Research review and a standing committee to make and implement suggestions. The future belongs to forward looking companies only.
 
 
 
  Author: Anonymous Medzilla Reader Jun 17, 2012, 01:58PM
 
    Re: Survey: Site and Study Team Issues   Log In to Report Post
 
   1. I have not had this problem at all. I think you'll always have an issue with CRC's that need their hand held, but generally, even if you to stand over them to get entries made, it still can be done if you ask appropriately.

2. Yes. Two hours for a 13-15 page report is simply not possible. I just charge the actual time it takes to get the work done. However, if one maximizes their time and plans workload there should never be a missed deadline.

3. I have not had any issues with my expense reports and have never been asked for a boarding pass.

4. I have always been adequately trained.

5. The IT systems we use aren't great, but once you get the hang of it, it's usually fine.
 

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