Clinical Research Coordinator I

Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.

Responsibilities

Develops in-depth understanding of each study protocol to ensure adherence to FDA, GCP, and ICH Guidelines; Prepares and submits regulatory documents; Identifies potential study participants according to inclusion and exclusion criteria; Obtains informed consent according to GCP; Schedules subject visits; Prepares labs/tests per protocol; Manages study drug storage and accountability; Administers investigational product according to protocol and physician direction; Monitors and evaluates patients' condition; Consults with PI regarding investigational product administration; Conducts routine assessments of subject's response; Educates subjects about study particulars; Documents subject information per ALCOA; Meets with study monitor to review and correct data; Reviews labs/tests with physician; Reports subject progress, complaints and issues to PI, sponsor, or IRB; Conducts ongoing assessments of study execution; Notifies management and external parties of serious adverse events; Collects pre-study essential documents according to GCP and files appropriately in the study record; Maintains study file and subject participant records according to GCP; Provides list of participants to avoid improper billing; Ensures storage and maintenance of investigational product records; Completes clinical trials management system and case report forms; Attends Investigator Meetings

Requirements

Bachelor's Degree or an equivalent combination of education and experience; Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciences or other health related field; 2 to 5 years' healthcare experience; Willing to pursue CCRC or SoCRA certification when eligible; Current appropriate state licensure if applicable; Proficient with PCs and Microsoft Office applications; Good communication and organizational skills; Ability to work independently

Nice to have

Dialysis experience; Research experience; Advanced Degree

Benefits

Healthcare; Continuing Education; Paid Time Off; Collaborative Environment; Additional Perks; 401(k) Retirement Saving