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Title:  Lead, Research Operations

Division:  Psychiatry and Behavioral Sciences
Schedule:  Monday - Friday, 8 am to 5 pm
Work Location:  Houston, TX
Salary Range:  $70,100 - $96,737
FLSA Status:  Exempt
Requisition ID:  8609

Summary

This position will oversee, manage, and lead the daily operation of Dr. Sanjay Mathew's research program. The selected candidate will provide the daily operational oversight of research operations that are beyond the BCM site and extend to MEDVAMC, Methodist, Greenpark Pharmacy, NMS Labs, and international Universities. The daily operational oversight duties include monitoring and responding to any changes in the clinical research objectives, funding agency, sponsor environment, research regulations, and standards.

Job Purpose

Oversees, manages, and leads day-to-day research operations to ensure that current and long-term business goals are met.

Job Duties

  • Provides oversight to the research program and operations of regulatory submissions, including Local/Central IRBs, FDA, DSMB, Scientific committee submissions, approvals, amendments, and closeouts. Ensure regulatory submissions are compliant and submitted within required deadlines. 25%
  • Ensures the ongoing review and development of process improvement to maximize the program's productivity and recruitment campaigns. Utilize established portals in and outside the BCM network to provide strategy development, and proper implementation. 20%
  • Monitors research project expenditures; make recommendations pertaining to work operations and priorities to meet research objectives. 15%
  • Creates, analyzes, and monitors research project time-lines. 15%
  • Oversees regulatory activities that lead to timely regulatory submission. 15%

 

Research Operations Lead will be responsible for protocol training, developing a structure/plan (writing SOPs), where the research team can work efficiently for the prosperity of the program growth, and remain compliant with the new changes as per sponsor's guidelines. The position will be responsible for the implementation of regulatory submissions with or without a team member's help as per the program's need and in the best interest of effective time management by the action plan.

This role will utilize the following portals: BCM SAP, BCM SRM, IMEDNET, RAVE, INFORM, CLINICARD, BCM CONCUR, BCM SMS, BCM BRAIN, NIH ERA COMMONS, NIH ASSIST, NIH NDA, VA E-VACS, VA SRS, IMEDNET, NCBI, MERCK SIP, MERCK CLMS, MEDVAMC HVAREF, and VA CSP relation operations.

Minimum Qualifications

  • Bachelor's degree. 
  • Six years of relevant experience. 

Other

Research program is sponsored by various institutes, including the Department of Veterans Affairs, the National Institutes of Health (NIH), Foundations, and industry partners. The position is required to handle diverse program operations by ensuring regulatory compliance and accomplishing program goals as the program includes collaborations with Psychiatrists, Neurophysiologist, Statisticians, Scientific Programmers, Psychologists, Anesthesiologists, Ophthalmologists, fMRI technicians, postdocs, Research Coordinators, Nurses, Pharmacists, and Interns.

 

 

 

 

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

 8609

CA