CLINICAL RESEARCH COORDINATOR II

To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.

To support screening and participant eligibility determination, working with more senior team members to ensure compliance.

To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).

To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Study Subject Interactions - Participant screening, recruitment and consent, visit scheduling, performing required study procedures such as administration of phone screening scripts, questionnaires, surveys, etc., facilitation of investigator communication with study participants.

Study Data Management - Utilizing REDCap and OnCore, performs study data input, monitoring, and quality control for ongoing clinical research programs. Ensures study participant consent, HIPAA release, medical records release, and interest in future research is documented according to protocol, and electronically filed and tracked as applicable. Assists with the development and production of enrollment and participant data reports. Ensures participant data integrity and performs quality assurance checks.

Regulatory Compliance - Prepares study regulatory submissions to UAB IRB or to central IRBs for consortia projects and maintains regulatory documents for all active research studies. Assists with the development of initial protocol submissions, amendments, annual renewals, and applicable personnel changes.

Other Study-Related Duties - Meeting with and communicating with investigators and study teams, attending regular internal staff meetings, and attending other required and job-relevant meetings. Completes and maintains required training for human subjects research and clinical facility access.

Performs other duties as assigned.

The ideal candidate for this role is an experienced, data-savvy Clinical Research Coordinator who bridges the gap between participant recruitment and technical data management, who thrives in a fast-paced clinical research environment.

Possess in-depth knowledge of and experience with regulatory compliance from study startup to closeout, and a strong ethical foundation in human subjects research.