Division: Obstetrics and Gynecology

Work Arrangement: Onsite only

Location: Texas Medical Center, Houston, TX

Salary Range : $67,704 - $78,514

FLSA Status: Exempt

Work Schedule: Monday - Friday, 8 a.m. - 5 p.m.

Summary

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.

Job Duties

Protocol/Project Management:

• Assist investigators in the overall conduct of clinical trials.
• Maintain current regulatory files with study sponsors.
• Monitor IRB submissions and respond to requests and questions with central and local IRBs.
• Interact 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.

Study Management Responsibilities:

• Interface with research subjects with the purpose of recruitment, screening, and enrollment.
• Resolve all issues related to research study protocols.
• Evaluation of subjects for study eligibility and continued participation in the study.
• Consent of subjects to research protocols following Good Clinical Practice guidelines.
• With appropriate training will perform venipuncture, neonatal biometric measurements, specimen collections and processing.
• Assist with audits of study trials records and specimens collections.
• Appropriate handling and distribution of investigational products to subjects.

Data Management Responsibilities:

• Oversees the data management of studies ensuring accurate study subject documentation.
• Entering subject data into all required electronic data collection systems.

• Performs other job duties as assigned.

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.

Preferred Qualifications

• Master's degree in a related field.
• Familiarity with EPIC/EMR.
• Proficiency with Microsoft Excel software and REDCap database
• Working knowledge of central and local IRBs such as WIRB, Advarra etc.
• Previous experience in obstetrics
• Self-directed, independent and organized.
• Effective communication skills, both orally and in writing.
• Experience with computer spreadsheets and database management (experience with developing and maintaining databases in RedCap preferred).
• Ability to understand and implement patient studies and protocols.
• Strong interpersonal skills necessary to manage less experienced research personnel and coordinate research studies between a multi-disciplinary research team.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Requisition ID: 19804