Employee Evaluation.
Comment: Currently, I am actively working on the ALPHA Research Study sites in the United States and Canada to resolve the Data Management queries by sending the queries to the Research Site Study Coordinator and later making follow-up phone calls to see whether the queries have been resolved or whether there is any assistance required. Additionally, I also ensure that all open queries in the INFORM-EDC database for Alpha are resolved within the required time frame in order to keep the metrics in excellent shape. While working on the Alpha database, I also take account of the Database Lock dates and I keep my CRA and Study CTM updated on all these tasks.
I am also actively working with the site staff to get access to the INFORM-EDC database when required and I also do follow ups with the research sites for the ePro-Adjudication queries resolution (resolving of queries such as MAC, OIRC, HPR, CV, HERC, GI). In such cases, I ensure that queries raised by WCC Team are dealt with in time, and the tracker in the e-Room is updated weekly to reflect the Adjudication query work flow status which is shared with our Sponsor i.e. the ALPHA by my Study Clinical Trial Manager.
On my OMEGA Research Study sites in US and Canada, I ensure that the Research Sites-Study Coordinator addresses Data Management queries timely in the MEDIDATA RAVE EDC system. Finally, I also work with site staff to get access to RAVE EDC when required for review and resolving issues.

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Goal No 3: First Patient Recruitment.
Description: A site-specific recruitment plan must be written for each site; and reduce the time between SIV and Site-ready-to-recruit period to 24 hours.
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Site Specific Recruitment Plans:
• Site specific recruitment plans are in place, and not generic for the study.
• CRA works with the site prior to the SIV to ensure that site will proactively identify the first patients they would invite for screening right after the SIV.
Site activation:
• CRA will proactively work with the CTL/CTM, and the CTA to ensure all supplies and access all study systems will be available by the SIV and that the site can immediately start screening.
Employee Evaluation.
Comment: In the OMEGA study, the new research site enrollment has been extended so I am actively working with the Study Start-up team on the new site identification process. I also work with already enrolled research sites to send us potential site information on who may be interested in conducting research. Site Initiation Visits or SIV which are generally conducted on phone are scheduled routinely once the enrollment process is complete. I also ensure that all those newly enrolled sites receive supplies such as ISF and Patient binders.
Since I am now promoted as Clinical Research Monitor or CRA, I will be visiting these research sites frequently to do SIV task.

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Goal No 4: First Site Initiation Visit (SIV).
Description: Complete a pre-study visit (PSV) within 14 calendar days (CDS) after the site has been approved for PSV.
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SIV Completion:
• EU and NA - SIVs completed within 14 calendar days (CDS) of Critical Document Package (CDP) approval.
• APAP and LATAM - SIVs completed within 14 calendar days (CDS) of Critical Document Package (CDP) approval.

PSVs:
• CRA to contact site for potential PSV dates right after site approval for PSV.
• CRA to complete needed training as soonest possible.
• Phone PSVs should be done with shorter timelines to compensate for potential delays of on-site PSVs.
SIVs:
• CRA to follow-up with SSUA/SMA about the planned CDP submission/approval dates.
• CRA to check site availability for SIV proactively around the planned CDP approval date, and pre-book visits with site.
• CRA to proactively review annual vacation plan against the planned SIV dates, and proactively seek solutions when dates conflict.
PSV Rating:
• Far Exceeds Expectations: All assigned PSVs (100%) completed within 14 CDS of site approved for PSV
• Exceeds Expectations: About 95-99% PSVs completed within 14 CDS of site approved for PSV
• Meets Expectations: About 90-95% PSVs completed within 14 CDS of site approved for PSV
• Meets Some Expectations: About 85 - 90% PSVs completed within 14 CDS of site approved for PSV.
• Does not meet Expectations: Less than 85% PSVs completed within 14 CDS of site approved for PSV
SIV Ratings:
• Far exceeds Expectations: All SIVs completed within 14 (21) CDS from CDP approval of each site.
• Exceeds Expectations: About 95-99% completed within 14 (21) CDS from CDP approval of each site
• Meets Expectations: About 90-95% completed within 14 (21) CDS from CDP approval of each site
• Meets Some Expectations: About 85-90% completed within 14 (21) CDS from CDP approval of each site
Does not meet Expectations: Less than

The signature assignment for this course is eight (8) to ten (10) p...