The Pediatric Pulmonary Section is home to one of the largest Cystic Fibrosis (CF) Care Centers in the United States. As part of the Center, we have a very active clinical CF research unit. Our research team members are involved in Phase II-IV clinical trials. The Baylor CF research unit works with infants, pediatric, as well as adult subjects who have cystic fibrosis. The CF 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. The coordinator will work independently to manage all significant aspects of the large and small clinical research trials under the supervision of the primary investigator. The candidate will train and provide guidance to less experienced staff. This candidate will also provide advice to the group in determining our participation in solicitation for new study trials. The candidate will determine effective strategies for promoting/recruiting research participants in long term clinical trials. The candidate will have the opportunity to utilize or develop numerous clinical skills including pulmonary function testing, ECG, venipuncture, sample collection, etc.Job Duties
- Assists investigators in the overall conduct of clinical trials
- Maintains 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
- Provides leadership for all studies/trials assigned, develops and implements policies and procedures, and identifies and implements corrective actions/process when required.
- Interfaces 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
- Evaluates subjects for study eligibility and continued participation in the study
- Consents subjects to research protocols following Good Clinical Practice guidelines
- With appropriate training will perform venipuncture, ECG, spirometry, sweat testing, specimen collections and processing
- Collects, processes, ships and maintains paperwork for blood and/or other biological specimens according to study protocol.
- Assists with audits of study trials records and specimen collections • Appropriate handling and distribution of investigational products to subjects
- Oversees the data management of studies ensuring accurate study subject documentation
- Enters subject data into all required electronic data collection systems
- Retrieves, maintains and submits test results to appropriate study sponsors or PIs.
- Reports serious adverse events to include follow-up when necessary.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- Two 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.