Title:  Lead, Clinical Research

Summary

The Cystic Fibrosis research unit is looking for the ideal candidate that is highly driven, self-motived, and eager to work both independently as well as be part of a dynamic team of research coordinators and physicians. This position will be responsible for the overall coordination of the clinical trial start up process (feasibility, implementation and regulatory) and conduct of both Therapeutic Development Network and pharmaceutical sponsored clinical studies. This position will also coordinate and implement clinical research education and policy development with the Baylor Pediatrics-Pulmonary Division. The candidate will have the opportunity to utilize or develop numerous clinical skills including pulmonary function testing (spirometry), ECG, venipuncture, sample collection, etc. as the coordinate clinical research studies under the supervision of the primary investigator.

Job Duties

• Assisting investigators in the overall conduct of clinical trials 
• Maintaining current regulatory files with study sponsors
• Monitors IRB submissions and responds to requests and questions with central and local IRBs
• Interacts with study sponsors and monitors and reports SAEs and resolves study queries
• Interface with research subjects with the purpose of recruitment, screening, and enrollment; which may include scheduling research visits, procedures and lab testing. 
• Resolves all issues related to research study protocols
• Evaluation of subjects for study eligibility and continued participation in the study
• Consenting of subjects to research protocols following Good Clinical Practice guidelines
• With appropriate training will perform venipuncture, ECG, spirometry, sweat testing, specimen collections and processing. Will collect, process, ship and maintain paperwork for blood and/or other biological specimens according to study protocol.
• Appropriate handling and distribution of investigational products to subjects
• Entering subject data into all required electronic data collection systems
• Retrieves, maintains and submits test results to appropriate study sponsors or PIs.
• Report serious adverse events to include follow-up when necessary.
   

Minimum Qualifications

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

Preferred Qualifications

• Direct experience in clinical research and clinical research terminology - Experience with managing projects
• Working knowledge of local and central IRBs such as WIRB, Advarra, etc.
• Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
• Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook
• Effective verbal and writing skills at all level including to senior leadership; prior experience with oral presentation
• Familiarity with EPIC/EMR - Working knowledge of central and local IRBs such as WIRB, Advarra etc.
• Previously worked with a pediatric experience
• CCRC, CCRP, SOCRA- or ACRP-certified