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 Purpose

Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants. May supervise other research staff.

Job Duties

Protocol/Project Management:

• 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.
• Provides leadership for all studies/trials assigned, develops and implements policies and procedures, and identifies and implements corrective actions/process when required.

Study Management:

• Interface with research subjects with the purpose of recruitment, screening, and enrollment.
• 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, 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:

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

Minimum Qualifications

•  Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• 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
• CCRC, CCRP, SOCRA registration