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
- Completes 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
- Develops protocol amendments, informed consent, manual of operations, and data instruments for amendment packages for consortium
- Develops and maintains of processing and tracking systems for regulatory documents, subject follow-up outstanding queries, etc.
- Completes annual progress reports for grant renewal
- Tracks milestones and progress of study deliverables
- Manages membership, meeting minutes, and communications for consortium
- Assists study PIs with manuscript preparation by proof-reading drafts, ensuring consistency, and working directly with statisticians in order to obtain statistical data
- Acts as liaison between statisticians and clinical investigators; assists with preparing tables and figures for manuscripts, publications, and study reports
- Approves 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
- 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.