Summary

The senior research coordinator will be expected to support an investigator initiated multi-site clinical trial. This position will independently help with the setup and startup of the study and then onboarding new sites. They will also be responsible for TCH study activities which include (but are not limited to) screening, enrollment, compensation reimbursement, scheduling visits, writing and overseeing regulatory requests (i.e. IRBs, consent forms, etc.), data entry and monitoring of research participants. Ensures accurate data collection and compliance for all sites, documentation, organization and safety of research participants.

Job Duties

Clinical Study Coordination (50%)

• Responsible for screening, recruiting, consenting and enrolling participants.
• Schedules all research visits, procedures and follow ups.
• Collects patient information and samples as appropriate, and maintains study records.
• Participates in study meetings.

Multi-site study Coordination (35%)

• Responsible for coordinating study among multiples sites.
• Plans and implements the overall study processes/activities.
• Creates manual of operations for study. Initiate new sites for study.
• Trains site coordinators on study, documentation, and operations.
• Manages the different scopes, ensures ongoing communications between the sites, follows up on action items and reports overall progress.
• Identifies study issues, alerts investigator to issues, and helps problem solve. 

Regulatory (15%)

• Writes, maintains and prepares IRB protocol documents, consent forms, and regulatory documents.
• Ensures timely submission and approval of IRB renewals.
• Maintains records and regulatory documents for research studies. 
• Responsible for auditing site patient charts. 

Performs other job-related 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

• Experience leading a multi-site study.
• Experience with REDCap, Epic, Institutional Review Board (IRB) preparation and development, Good Clinical Practice.
• Independent critical thinking and troubleshooting regarding assigned projects. 
• The ideal candidate will be self-motivated and capable of working both independently and as a member of the project team.