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Senior Research Coordinator

Baylor College of Medicine

Houston, TX

Job posting number: #7100515 (Ref:11142-en_US)

Posted: May 21, 2022

Application Deadline: Open Until Filled

Job Description

Summary

The Department of Medicine, Section of Gastroenterology & Hepatology, is seeking an experienced, reliable and enthusiastic Senior Research Coordinator to manage the pre- and post-award processes for grant/contract activities. The candidate will work with principal investigators on grant submissions, including budget creation and gathering crucial documents for submission. The position requires excellent leadership skills, collaboration, and ability to advance the section's research mission.

Job Duties

Main responsibilities include:

  • Oversees site operations for multisite and single site studies 
  • Performs study coordination/research quality evaluation for each site, including regulatory document control, ensuring protocol compliance and subject safety, monitoring data entry, and ensuring that all sites complete reporting requirements
  • Assists with development and maintenance of electronic data capture (EDC) by creating case report forms (CRF) and performing user acceptance testing (UAT)
  • Manages trial master file (TMF) for study
  • Complete submission of amendments in BRAIN and acts as direct liaison to local Institutional Review Board (IRB) regarding study submissions
  • Assists with the movement of contracts, material transfer agreements (MTA), and data transfer agreements (DTA) through pipeline; ensures that statements of work (SOW) and other information related to study conduct is accurate within contracts
  • Performs site initiation visits and evaluates site readiness for start-up
  • Ensures validity, completeness, and correctness of clinical data collected by sites in collaboration with study PIs, statisticians, and technical team; queries sites on missing/incorrect clinical data
  • Development of protocol amendments, informed consent, manual of operations, and data instruments for amendment packages for consortium
  • Development and maintenance of processing and tracking systems for regulatory documents, subject follow-up outstanding queries, etc.
  • Complete annual progress reports for grant renewal
  • Track milestones and progress of study deliverables
  • Manage membership, meeting minutes, and communications for consortium
  • Assist study PIs with manuscript preparation by proof-reading drafts, ensuring consistency, and working directly with statisticians in order to obtain statistical data
  • Act as liaison between statisticians and clinical investigators; assists with preparing tables and figures for manuscripts, publications, and study reports - Approve patient compensation for local study sites
  • Generates reports to be used for invoicing sponsors - Implements changes in protocols in order to ensure that study needs are being met effectively

Minimum Qualifications

  • Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
  • Five 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.

 11142

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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More Info

Job posting number:#7100515 (Ref:11142-en_US)
Application Deadline:Open Until Filled
Employer Location:Baylor College of Medicine
Houston,Texas
United States
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