DM Clinical Research is one of the leading site management organizations in the country and enjoys alliances with several big Pharma and CROs.
We are seeking individuals that have a passion for clinical research and have an ability to manage multiple trials at our dedicated site in Tomball (NW Houston)
The individual will be required to
1. Ensure Protocol Compliance and Adherence
2. Ensure Adherence to Sponsor Metrics – EDC entry, Query resolution, IMV Action items follow up
3. Staff Training – Initial Study start and any retraining needed ongoing basis for deviations, non-compliances
4. Ensure site’s IMV preparedness – all action items from previous IMV resolved, response sent to the CRA and prepare for the upcoming IMV. Plan to meet with the CRA to get a rundown of all action items, get overall understanding on data quality and major issues
5. Meeting with PI weekly – For all studies - General Study update, Recruitment update, Any issues, retraining needed - document meeting minutes
6. Meeting with Sub-I monthly for all studies - General Study update, Recruitment update, Any issues, retraining needed - document meeting minutes
7. Review IMV Follow up letters – monthly
8. Review Protocol Deviation reports prior to sponsor and or IRB Submission
9. Review Patient Management tracker for ET rate, SF rate, OOW visit rate
10. Review Study specific protocol deviation log monthly to identify trends – PI or Site Director to conduct retraining as applicable
11. Ensure SOPs and any other internal processes followed
12. Prepare for PSV, SIV – for upcoming studies
13. Second person QC on the Source Documents – prior to SIV, cross check against protocol, eCRF guidelines, EDC Screen shots
14. Manage communication with Sponsor/CRO
15. Monthly or Bi-weekly Meetings with immediate supervisor for overall updates
16. QC plan – Based on risk assessment
High Priority Studies – 100% QC of 50% of subject charts for next 2-3 months and make a plan to spot check after the initial 3 months, identify trends
Low risk studies – 100% QC 20% of subject chart, - random sample, monthly
SAEs – QC 100%
Essential Regulatory Documents QC - monthly
Delegation Log, - make sure log is current, delegation of responsibilities reflected accurately
Training Log – ensure initial staff training at the SIV, any protocol amendment training, any staff retraining on deviations/non-compliance as applicable
IP Accountability Logs
weekly meetings with new staff, assess training and performance
monthly one on one meetings with all CRCs, RA, Admin
Plan and monitor Ad campaign Metrics
Weekly meetings to assess prescreening, screening, randomization goals
Assess recruiter’s productivity, recruiter goals, any retraining as needed
Review and approve phone screens, revise phone screens on interim basis as applicable
Please apply only if you have the experience to successfully conduct this job or can grow into it.
We offer a great work environment and salary will commensurate with experience.
Please send resumes to firstname.lastname@example.org
DM Clinical Research (DMCR) is a network of investigator sites working with experienced investigators in multiple therapeutic areas to conduct industry-sponsored Phase II-IV Clinical Research trials.
Our goal is to provide impeccable quality data while continuously meeting Sponsor goals. We are able to do this by employing and retaining a staff of top-notch professionals who have a passion for clinical research.