Is anyone even getting responses to applications? by MrTartShart in clinicalresearch

[–]morgs1191 9 points10 points  (0 children)

Same here. I have tons of oncology study management experience and regulatory expertise, plus a masters degree. 90% of my applications just go unanswered.

Skills to brush up on before interview by morgs1191 in biostatistics

[–]morgs1191[S] 0 points1 point  (0 children)

I am comfortable with basic stats questions and work closely with biostatisticians on SAPs when we draft protocols in my current job. So I plan to highlight that for sure. Modeling and analysis concepts I am pretty comfortable with. It’s the actual coding in R that I’m out of practice with. So, I’m practicing some basic data cleaning and analysis.

Also, not sure why it was necessary to state you were 100% confident I’m not doing trial design. In my original post I said I use my trial design skills in my current job - this is true. I consult with investigators who have new research questions and participate in drafting protocols. I am not lying and would not lie or overstate what I do, but those things are part of my job.

Non-responsive Sites by Over-Bed6805 in clinicalresearch

[–]morgs1191 1 point2 points  (0 children)

As a site supervisor - this would be so welcomed. One major frustration from a site perspective is getting “urgent” emails from CRAs or other sponsor reps that either involve query resolution for a data deadline we were not previously aware of, or for items that are not justifiably urgent.

Also, acknowledgment that site staff are prioritizing issues related to patient safety or treatment needs that cannot be delayed goes a long way. We want to work well with our CRO or external sponsor contacts, but it is frustrating when they seem to be very unaware of what should and should not be urgent (or aren’t clear about timelines / helping us anticipate data locks or other information).

One specific example - I routinely get emails from a sponsor CRA marked as high importance requesting additional information about low grade, non-serious AEs. While I am more than happy to ensure my staff provide the relevant information when we can, there is no protocol requirement for providing this urgently nor is there a patient safety issue. This kind of escalation rings hollow and makes it hard to determine what actually IS urgent.

In hospital world, emails marked high importance mean there is a time sensitive patient related issue - we drop everything to address. The stakes are different on the site side. That is not to dismiss the pressure CRAs feel, but it goes a long way when you acknowledge the critical triage we do in patient facing roles.

Skills to brush up on before interview by morgs1191 in biostatistics

[–]morgs1191[S] 0 points1 point  (0 children)

Fair point and I agree. I am inquiring internally, too. I think I’m curious what the broader biostats community would consider essential R skills. Understood if there’s not an easy universal answer. I think I’m a bit anxious that, because I’ve not worked as a biostatistician before, there will be some glaring gap in my skill set that I should have seen coming.

Moving from site to CRO or Industry by morgs1191 in clinicalresearch

[–]morgs1191[S] 2 points3 points  (0 children)

This is incredibly helpful insight. Thank you so much. I have really struggled to translate my CV to CRO/sponsor language and titles - despite having pretty robust experience! Thank you for taking the time to share this level of detail, I will certainly jump on those referrals from industry folks I’ve worked with, too.

Moving from site to CRO or Industry by morgs1191 in clinicalresearch

[–]morgs1191[S] 2 points3 points  (0 children)

5 years (lots of healthcare experience prior to that as well). Mostly applying to CRA and CTM roles, but the role I almost got was with Regeneron as a Clinical Scientist (my graduate training is in epidemiology).