Lead, Clinical Research - Operations Lead - Pediatrics - Research Resources Office (90005902)

Baylor College of Medicine

Houston, TX

Job posting number: #7092687 (Ref:10110-en_US)

Posted: January 21, 2022

Application Deadline: Open Until Filled

Job Description

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 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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