About Me and My Experience Flashcards
1
Q
Example day at work
A
- TMF review preparation - meeting w/ DSQ to prepare
- CSR appendix 16: working w/ x-func groups to collate info. And CRO to collect PI information including CVs and FD, ensuring we’re in compliance, and IRB/EC information
- Some site management activities such as providing info to MM such as results in LabLink, tracking down delayed kits for sites and ensure on track to arrive in time, escalating site data entry issue to CRA
- Newsletter review
- CT.gov and CTMS updates to reflect site status change
2
Q
Vendor management experience
A
- Newsletter
- Monthly Accruals
- Investigator Portal
For each, elaborate on ways I’ve “managed” each
3
Q
Site management experience
A
- AUS site management in startup and initial dosing during US hrs
- Action medical monitor requests for information, pulling info from LabLink, EDC or managing CROs to obtain reports or info from site directly
- Liaising w/ CRO to raise CRF data entry issues or delays
- Track down delayed lab kits for sites when issue raised
- Pulling reports from EDC as requested from other cross-functional groups
- Confusing or problematic queries firing in EDC that troubleshoot w/ DM
4
Q
Site selection experience
A
- Working w/ team on feasibility questionnaires
- Send feasibility Qs to sites and ensure completion w/o gaps in info
- Analyze responses and report findings back to team – does site have capability to run studies – are fundamental criteria met, how many potential participants
5
Q
CRO management experience
A
- eTMF filing expectations: new CRO, filing issues provided content list, I lead a training on expectations
- Collecting info for CSRs: found some discrepancies in investigator listing when referencing FDFs, CVs and Delegation of Authority Logs. Manage CRO to look investigate discrepancies at site, and make decisions on next steps from there (e.g. delay in signature on FDF = NTF required to justify)
- Manage on contact listings
- In site management, need CRO/CRA to obtain info from or provide feedback to site
6
Q
Tell me about yourself
A
- After graduating from UCB w/ degree in CogSci and undergrad rsch experience, started career at UCSF as CRC. Worked there 2 yrs in neurology. I was coordinating an ancillary study to a Ph3 trial (high dose Epo to newborns w/ HIE) which got me interested in clinical trials and I spoke w/ quite a few CRCs who made jump to sponsor side ClinOps and loved the work.
- Been CTA 1 1/4 years BMRN hemophilia A gene therapy. I’ve learned a lot very quickly on a fast paced team at a pivotal point in drug approval process.
- Seen lifespan of a study with Ph2, Ph3 and non-interventional studies in start-up, maintenance and close-out.
- Witnessed MAA/BLA filing and feedback from regulatory agencies (EMA/FDA) - partaking in preparations for inspections.
- Witnessed IND/NDA submissions for new studies and experiencing study start-up
- Close-out of non-interventional studies
7
Q
Experience with study start-up
A
- Kick-off meeting w/ new CRO
- VIM planning
- Site feasibility
- Site management
- Setting up new studies in CTMS
- Creating content lists and working w/ CRO to finalize
- Procure clinical trial insurance for different countries
8
Q
Experience with study maintenance
A
- eTMF health checks
- Newsletters
- CSRs
- Site communications/Portals
9
Q
Leadership experience
A
- Lead CRC for national 9 site phase III ancillary study: training new CRCs, leading calls and troubleshooting issues, coordination of EEG sharing
- Interns at BioMarin and UCSF: train and delegate tasks
- Lead CRC for GENE, EIDCP, POPS, HEP/HEP2/SUDEP
- Leading x-func teams to review various types of materials - pt facing and site facing, newsletters, CT.gov, wallet card
- Leading team calls and taking mins
10
Q
Interdepartmental initiative experience
A
- Regulatory data enrichment project: go in to regulatory filing records and verify medidata (categories and attributes) assigned to documents and folders as part of large initiative
- Study dashboards – publish these weekly for cross-functional teams to view progress on all studies pulled from CTMS
11
Q
My qualities/strengths I can bring to the role
A
- Proactive and diligent hard worker - I see all projects through on time and I’ve never been a procrastinator – I take full ownership of my work
- Curious and love to continually learn
- Effective communicator - on a performance review I was described as diplomatic (empathetic in dealing with others and can achieve peace and facilitate discussion well, acknowledging all sides). Important when working with cross-func groups, CROs, and vendors to keep partnerships uplifting and productive
- Reliable – I follow through and plan ahead well to deliver with quality work
- Self motivated
12
Q
What experience I can bring to the role
A
- A lot of experience in clinical research from site and sponsor side – holistic view of clinical trials and understanding for the roadblocks and bureaucracy sites face as well as the often tight timelines and faster pace on the sponsor’s end – equipped to find a path forward that works for all parties – listen to concerns of sight and brainstorm a creative path forward
- Experience with many stages of a study from start-up to close-out to filing w/ Reg agencies
13
Q
Why are you changing jobs
A
Not necessarily changing jobs. I’m particularly interested in this opportunity because the role is really interesting to me I think there could be good learning and growth opportunities. I’ve heard great things from Michael about the role and company and the work being done at Gilead is impactful - robust pipeline
14
Q
Room for improvement
A
Sometimes get lost in details – I’ve been working on taking a step back to focus on the bigger picture so that I’m not spending more time than I need to on certain tasks
15
Q
Trainings I’ve led
A
- Interns on systems we use – eTMF, LL, SharePoint. Delegate tasks based on trainings
- CRCs for EEG study
- CROs – eTMF overview and uploads
- CLS – CRO ePIP training and bring Qs to CRO from CLS
