Job Summary:
In conjunction with the Medical Director, establishes the infrastructure for data safety monitoring (DSMP) of GCRC-approved protocols. Interested applicants should go to www.medschooljobs.org and apply directly to position 188602SB.

Duties:
* Establishes and maintains records for initial and follow-up data-safety monitoring plans for GCRC protocols.
* Tracks and maintains records of: adverse event reports, BCM IRB renewals, amendments, deviations, exceptions, and DSMB review outcomes for GCRC protocols.
* Facilitates discussion of patient safety issues and concerns within the GCRC by way of coordination and direction of GCRC nursing staff meetings.
* Performs Quality Assurance activities.
* Oversees coordination of Data Safety Monitoring Board (DSMB) meetings as appropriate for GCRC-approved protocols.
* Prepares for the initiation of new clinical research protocols.
* Reviews and assesses DSMPs (data safety monitoring plans) within GCRC protocol submissions for feasibility, clarity, and subject safety.
* Assures that the submitted data safety monitoring plans are in compliance with sponsor, institutional, and/or NIH and federal requirements.
* In coordination with the Medical Director, provides list of comments and suggestions for PI following review of DSMB.  

Education Required: Bachelor's degree in related field.

Experience Preferred: Two years of relevant experience in assurance and compliance, research, patient relations, health care, medical/academic setting or communications. The successful candidate will have previous experience with reviewing clinical research proposals.

Baylor College of Medicine is an Equal Opportunity, Affirmative Action, Equal Access Employer.