Summary

The ideal candidate will be highly driven, self-motivated, and eager to work both independently and as part of a dynamic team of research coordinators and physicians. The coordinator will be responsible for all aspects of research studies under the supervision of the principal investigator, including regulatory requirements, communication with study sponsors, subject recruitment, accurate data collection and documentation, oversight of study participant safety, data entry, and other study-related activities.

Additionally, this is a very hands-on position that provides the opportunity to utilize and further develop a variety of clinical skills, including pulmonary function testing, ECGs, venipuncture, sample collection, and more.

Job Duties

Protocol/Project Management:

• Assists investigators with the overall conduct of clinical trials.
• Maintains current and accurate regulatory files with study sponsors.
• Monitors IRB submissions and responds to requests and questions from central and local IRBs.
• Interacts with study sponsors and monitors, reports serious adverse events (SAEs), and resolves study-related queries.
• Provides leadership for assigned studies/trials; develops and implements policies and procedures; and identifies and implements corrective actions and process improvements when required.

Study Management:

• Interacts with research subjects for recruitment, screening, and enrollment, including scheduling research visits, procedures, and laboratory testing.
• Identifies and resolves issues related to research study protocols.
• Evaluates subjects for study eligibility and continued participation.
• Obtains informed consent from subjects in accordance with Good Clinical Practice (GCP) guidelines and study requirements.
• With appropriate training, performs venipuncture, ECGs, spirometry, sweat testing, and specimen collection and processing.
• Collects, processes, ships, and maintains required documentation for blood and/or other biological specimens according to study protocols.
• Assists with audits of clinical trial records and specimen collections.
• Ensures the appropriate handling and distribution of investigational products to research subjects.

Data Management:

• Maintains accurate, complete, and timely study subject documentation.
• Enters subject data into electronic data collection systems and ensures data accuracy and completeness.
• Ensures prompt reporting and follow-up of serious adverse events (SAEs).
• Perform other jobs 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.
• Familiarity with EPIC/EMR systems
• Working knowledge of central and local IRBs, such as WIRB and Advarra
• Completion of Good Clinical Practice (GCP) training
• Working knowledge of clinical research terminology
• Effective communication and interpersonal skills
• Previous experience working in a pediatric research or clinical setting
• CCRC, CCRP, or SOCRA certification preferred