Come to me, all you who are weary and burdened, and I will give you rest.
Matthew 11:28 (context)
The last week at work left me utterly exhausted, with no time for much besides sleeping, eating, and maintaining basic personal hygiene. I’m going to talk a little bit about work now, more as a way to lay the whole week to rest than out of any expectation that you, my long-suffering readers, might waste time on the minutia of my boring life. The short story is that I basically killed myself this week trying to ship out some reports.
The long story is…Where to start? This Monday, my immediate boss Kelly announced her intention to transfer to a new job within the company; at the same time, she told us that they had hired a new technical writer to join me and Janice, a fellow named Jeffrey Ellis. He starts on Monday, and Kelly leaves for good on Friday. A couple days later, the whole Reporting Group — comprising twenty or thirty total writers and two other managers — met and received the same news. The Associate Director of our group laid out our new organizational structure, which leaves us reporting to a woman I like just fine. She just won’t have Kelly’s years of experience and detailed understanding of the Laboratory Sciences department’s internal workings, a hard loss for us with the recent departure of our other experienced coworkers, Brenda and Erika. At this point, the in-house Lab Sciences reporting group will consist of three greenhorns, the most experienced (but least adept) with a year’s work at CRL under her belt. We have one senior writer working from home in upstate New York, and one in Puerto Rico. Three other Senior Medical Writers who haven’t to this point done much with us will become more involved in our group’s workings, doing Quality Checks (QCs) on our reports, writing some of the reports, revamping our aging templates, and generally lending their truly prodigious expertise to counter our vast inexperience. They actually understand the content of these reports, while Janice and I just skim the surface with formatting changes.
Anyway, all that is background to the real strain of the week. Last week, Kelly told me she had five final reports she needed me to prepare and finalize by March 1st, since the project scientist for those studies was going on maternity leave the 2nd and if we didn’t do them by Thursday, we would have to reassign the reports if we wanted to sign them within six months. These reports were written a year to two years ago, and the Sponsor just sat on them pretty much this whole time. Now they needed them immediately; it had become an emergency and we had to sign ASAP.
What you have to understand is that each report would normally take about an hour or two to finalize on the day we sign them, but additional reports don’?t necessarily add one full hour since I’?m already doing the steps once. Normally I do steps 6 through 18 on the day we sign. Finalization steps generally follow this pattern:
- Receive Sponsor and study director OK to finalize.
- Check to see if there have been any Sponsor-requested changes to the report. If yes, go to step 3. If no, skip to step 7. In either case, you still
- Send finalization request to schedule the signing report.
- Create a copy of the final report and send it, with any data and Sponsor comments, to QA.
- Receive audit back from QA. If no findings, get signatures and return audit (but not data or report) to QA. If there are findings, address the findings and return the report and maybe data back for resolution.
- Get QA statement from QA when the auditor is satisfied with responses; at this point, the auditor sends the audits to the Study Director for signatures.
- Prepare final report. This includes, but is not limited to:
- Print new copy of the final report for QC.
- Make QC changes to report; start filling out report shipping QC checklist.
- Create PDF of report.
- QC the PDF document and fill out PDF QC checklist.
- Create archive forms for project scientist to sign with the report. Often we create two copies of these forms, one for the data and one for the report.
- Create CD label document (to be printed on day QA and project scientist sign report)
- Create coverletter to go with CD (to be printed on day QA and project scientist sign report)
- Get project scientist signature on data archive forms and ask for access to Watson, a data-gathering program, to archive the data.
- Archive data from Watson, then burn data archive CD.
- Take data archive forms with the archive CD and, if you have it, the hard data to the Data Unit for archive before 2:00.
- Print out copy of the final report from the PDF, tab the signature pages, and wait for QA auditor to appear
- When the QA auditor shows up, get his/her signature. The QA statement may have incorrect dates, so you might have to reprint the Quality Assurance signature page.
- Take QA-signed report to project scientist to have him/her sign the report and report archive forms.
- Scan all three signed pages into PDF.
- Drop scanned pages into QC-checked final report PDF document, double checking that the date on the front page matches the sign date.
- Check that the links to those three pages still work.
- Burn report archiving CD, put with report and archive forms, and sign in to Data Unit for transfer to our archives facility.
- Burn final report onto CD for the Sponsor and the study director if the study director isn’t a CRL employee. If the study director works for CRL, or if the report is for a sister site, email the finished PDF to the study director and possibly some other people as well as sending the Sponsor a CD.
- Print CD label and coverletter and check them again.
- Stick the CD label on the CD(s), then check the CD(s) to be sure the report really is on there.
- Create and print shipping label.
- Ship CD(s) to Sponsor and/or study director.
- Send email to a specific mailing list to inform various people that a report has shipped.
And that’s all there is to finalizing a report! …Ignoring the bazillions of exceptions, of course. However, because of these reports’? age, I expected (correctly) that each report would take more than an hour. Also, they were Development reports, with lots of links and details to check, as well as a plethora of data to archive.
So I dutifully retrieved all fifteen data packages for the studies out of the Data Unit, made the sponsor-requested changes (all relating to the analytical reference standard), and sent the whole kit and kaboodle over to QA for audit. The auditor had to send us audits — with no findings, we hoped — by early this week, or we wouldn’t be able to sign the reports by Thursday. Audit turnaround can take a while, and we needed a study director’s signature on the addressed audits, with the study director was in Arkansas.
Late last week I received a call from the auditor telling me that she had started on the first report, BGY00001BR, and it was a complete mess. She sent back three of the five rep
orts for me to fix up, while she kept two that looked OK from a quick glance. This Monday I fixed the reports and sent them back to her for audit, fully expecting to not be able to actually sign the reports on Thursday.
Time went by, and I received nothing on the BGY reports. Finally, on Wednesday, I received a huge load of data packages in the shuttle from QA. My BGYs made up the bulk of that load, and I took them and the audits straight to the project scientist. We spent several hours addressing the five to ten findings on each audit — remember, five audits — and then I went upstairs to my cube implement the changes to the report. Hours later, I emerged from a BGY-induced haze and returned the audits for the project scientist’?s and her management’?s signature. Then I called the QA auditor and told her I had everything all set, and did she want me to send everything back over? No, she decided, it would be easier of she (the auditor) looked at everything as I had it amassed in our work area. She duly appeared a while later and spent hours verifying the changes that I had implemented. Then she went off to send copies of the audits to Arkansas for the study director in Arkansas to sign.
The auditor sent us a QA statement for each report, with the caveat that she wouldn’?t even think of signing the reports until she had received the signed audits back from the study director. I spent the rest of the day preparing the necessary forms to finalize the study, including one the study director had to sign (as you might have guessed, the study director is basically the god of the study, and everything related to that study has to pass through that person). Often study directors take days or weeks to return signed auditor or archive paperwork, but apparently this fellow wanted his reports, because Thursday morning I found PDFs of my signed forms waiting in my inbox. Hours of preparations later, the QA auditor contacted me: She, too, had received her paperwork back from the study director. We signed the reports at 1:15 that afternoon — the auditor and project scientist both looked very happy to have those massive studies done with when they signed their names — and I spent pretty much the rest of the day sending all five of the reports out.
Thursday we also had Nero installed on our computers because Roxio wasn’?t cutting it (no surprise there!), so I had a new burning software to work with on top of everything else. And somehow doing every step five times in a row took ages. Still, I shipped them all out on Thursday, and breathed an exhausted sigh of relief.
After shipping those reports, I felt very grateful that I had a half day on Friday. Also, I rode my bike both ways Monday through Thursday in the balmy 30° weather, which left me physically exhausted. Friday I took the car in for its 10,000-mile checkup (albeit 2,500 miles late) and Massachusetts state emissions test and left work at 11:30. It started snowing Thursday night, then switched to ice pellets or sleet or something, and by the time I left for work it was pouring rain. Of course, I had woken up at 2:30 and listened to the precipitation until 6:00 when my alarm went off, so I expected some kind of inclement weather. The rain continued all day. When I got home from work, I ate lunch and fell asleep. I slept all afternoon, only waking up at 4:30. We went to bed at 9:45, and I came awake this morning at 4:45. I hate waking up early, but at least it wasn’t 2:30 am.
Yet even throughout this high-stress, incredibly difficult week, I still felt this deep and abiding joy. Sometimes exhaustion also dragged at me, but generally I felt upbeat, even happy, and quite optimistic regardless of the conditions. I am learning, slowly, to consider it pure joy.