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Lead, Clinical Research - Study Start-Up Specialist

Employer
Baylor College of Medicine
Location
Houston, Texas
Closing date
Feb 25, 2022

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Discipline
Health Sciences, Clinical Research
Position Type
Full Time
Job Type
Research Scientist
Organization Type
Academia
Summary

Responsible for overseeing daily operations of clinical research studies for the Research Resources Office in the Department of Pediatrics. Position serve has an operations lead, or expert, for study intake, study initiation and feasibility. The position will ensure pre-study activities are set up and managed efficiently following RRO SOP's and established practices.

Job Duties

  • Serves as the RRO Operations Lead, or expert, on all new studies intake.
  • Manages RRO communication, reporting, SOP's and trainings associated with Confidentiality Disclosure Agreements (CDAs)
  • Serves as the primary lead communicating with internal and external stakeholders as part of new studies intake.
  • Schedules and manages all feasibility meetings, clinical trial site initiation visits, and clinical trial site selection visits
  • Serving as the RRO operations lead, collaborates with the research coordination leadership team to review potential clinical studies
  • Completion of all site selection questionnaires
  • Manages and updates the new studies folder on RRO shared drive
  • Coaches junior employees on RRO study set-up process and educate team on coordinating visits for sponsored studies
  • Designs and drafts pre-clinical study protocols and informed consent forms; assists with protocol approval process.
  • Develops, reviews, and revises standard operating procedures.
  • Oversees the timely execution of key deliverables and identifying critical risk areas.
  • Prepares and submits regulatory compliance documents.
  • Closes out study protocols and assists in end of study data analysis.
  • Coordinates research trials
  • Assists PI with database development
  • Performs other job related duties as assigned.


Minimum Qualifications

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


Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

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

10110

CA; SN

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