Research Coordinator III
Location: TCH Pavilion for Women
The Research Coordinator will work independently to manage all significant aspects of the large and small clinical research trials under the supervision of the primary investigator. Will train and provide guidance to less experienced staff. Provide guidance to the group in determining our participation of solicitation for new study trials. Determines effective strategies for promoting/recruiting research participants in long term clinical trials. Provide authorization for the purchase of supplies and equipment maintenance.
- Assist investigators in the overall conduct of clinical trials.
- Maintain current regulatory files with study sponsors.
- Monitor IRB submissions and responds to requests and questions with central and local IRBs.
- Interact with study sponsors and monitors and reports SAEs and resolves study queries.
- Provide leadership for all studies/trials assigned, develops and implements policies and procedures, and identifies and implements corrective actions/process when required.
- Interface with research subjects with the purpose of recruitment, screening, and enrollment.
- Resolve all issues related to research study protocols.
- Evaluate of subjects for study eligibility and continued participation in the study.
- Consent of subjects to research protocols following Good Clinical Practice guidelines.
- Perform venipuncture, neonatal biometric measurements, specimen collections and processing.
- Assist with audits of study trials records and specimens collections.
- Handle and distribution of investigational products to subjects.
- Oversee the data management of studies ensuring accurate study subject documentation.
- Enter subject data into all required electronic data collection systems.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- Two years of relevant experience is required.
- Familiar with EPIC/EMR.
- Proficient with Microsoft Excel software and REDCap database.
- Knowledgeable of central and local IRBs such as WIRB, Advarra, etc.
- Previous experience in obstetrics.
- CCRC, CCRP, SOCRA registration.
- Work is located in busy patient clinics, hospitals, office
areas, and/or laboratories where there are potential exposures to
blood borne pathogens (blood &/or other potentially infectious
materials), drugs, chemicals, radiation, and physical hazards.
Patient interaction and interaction with other employees is
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.