Year End Evaluation and Goal Setting Session with Real Staffing

Ellie Laidlaw of Real Staffing Group co-hosted a Clinical Operations facilitated discussion and networking event with Nadia Bracken, lead contributor to ClinOps Toolkit and Todd Tullis at the Veeva Systems San Francisco, California office. The event was truly informative thanks to the active participation of all attendees.  Read along as Ellie shares her take-away’s from last week’s open discussion.

What went well for your Clinical Operations team in 2013? What is on tap for next year?

The December ClinOps Toolkit event in downtown San Francisco was attended by a mix of pharmaceutical, medical device, and CRO clinical professionals interested in clinical operations goal setting.  This discussion centered around a year-end retrospective of 2013.  Todd Tullis of Veeva organized a written exercise inviting participants to share one or two topics in each of the following categories: what went well, what didn’t go so well, and a forward projection of 2014. He has written a brief summary of the event over on the Veeva Systems blog and Ellie’s summary of the clinical operations goal setting is posted here below:

Todd then asked each attendee to give a quick summary for the group to elaborate on why they wrote down individual topics.  Next, everyone voted on the topics they were most interested in discussing that evening. A great discussion ensued and Todd set a time limit on each topic to keep the session fast-paced and fun; the meetup flew by.  As an outcome of the session, attendees were able to set clinical operations goals they are excited about achieving and share perspective on industry trends they will be learning more about.

So What Did all those ClinOps Pros Talk About at the event?

Below is a list of the main selected topics, as well as my notes for a few of the key learnings for clinical operations goal setting:

Understanding What is important to Clinical Operations Directors

This was the most popular topic among the group, here are some of the valuable take-aways:

  • Being respectful of their time: communicating well, when approaching them with a problem also try to offer a proposed solution
  • Getting the work done quickly with high quality is of paramount important as compared to doing the work at a low cost
  • Reacting properly when mistakes are made or issues occur: own up to it and offer ways to prevent repeat errors in the future. Have the conversation even if it is hard.
  • When taking on one of their clinical projects: make sure they have visibility on the status of deliverables in a format that matched their preferences in the communication plan, so they can more easily report summaries up into their management team

New Employment Opportunities

Discussed how various members found their roles: recruiters, their own network, job postings

Making Investigator and Site Personnel’s Lives Easier

  • If possible, let the PIs be involved in the protocol development and operational advisory boards/committees
  • Include study coordinators in study planning from the beginning- they will know what is feasible
  • Utilize survey monkey or other electronic survey tools to get quick feedback from PIs

Site Solutions Summit Conference

Todd recently attended this conference in Texas and recommended it to the group. This event, targeted towards clinical site personnel and managers, is organized by Christine Pierre, Head of the Society for Clinical Research Sites and Rx Trials.

  • Started about 10 years ago, has grown to roughly 900 people
  • Attended by sites, IRBs, and high level sponsor executives
  • Venue for sites to meet sponsors, to discuss strategies, and attend workshops

SCOPE (Summit for Clinical Operations Executives)

  • Upcoming conference to be held in early February in Miami, 700+ attendees
  • Key notes speakers and workshops regarding all aspects of clinical trials from patient retention to sample logistics
  • Head’s up that Nadia is speaking at the conference on the topic of ‘Statistical-Based Approach to Feasibility and Site Selection’

Risk Based Monitoring

  • Understanding key risk-factors
  • The importance of looking at what is NOT there versus just what is there
  • ClinOps Pros have been doing this all along, why is it suddenly a hot topic?
  • Recent FDA Guidance and the Transcelerate initiative have given the method a distinct term and official endorsement
Nadia Bracken of the ClinOps Toolkit

Nadia Bracken of the ClinOps Toolkit

Todd Tullis of Veeva SystemsTodd Tullis of Veeva Systems

December 2013 ClinOps Toolkit Meetup group

December 2013 ClinOps Toolkit Meetup group

What do you think of the event? Even if you didn’t attend

We absolutely ran out of time to discuss everything at the meetup. Also, many folks who had expressed interest in RSVPing ultimately couldn’t attend this weeknight event due to scheduling or other conflicts. Nadia invited me to post this summary of clinical operations goal setting on the blog and LinkedIn so the discussion can continue. I hope I will hear from you in the comments or be email. I am looking forward to co-hosting another presentation or networking event with this group and other ClinOps Pros. If there is a specific topic you would like to discuss, or a passion/idea you would like to share, please email me at e.laidlaw@realstaffing.com or leave a comment below.

Ellie Laidlaw

Senior Clinical Operations Recruitment Consultant

Real Staffing Group
One Sansome, 36th Floor, San Francisco, CA 94104

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About The Author

Ellie Laidlaw

Senior Clinical Operations Recruitment Consultant, Real Staffing Group - Ellie is a third-party recruitment consultant in the clinical space for pharmaceutical and device companies. She specializes in placing Senior level and experienced Clinical Operations professionals in the San Francisco Bay Area. www.realstaffing.com