GoClinical Project Coordinator

Essential Functions: 

• Creates, maintains, and updates study details in CTMS and GoClinical. Including, but not limited to Sponsor, Study, Site and all related contact information, subjects, visits, issue tracking and all visit related details. 

• Serves as point of contact for day-to-day Site communications, document submissions and activity coordination. 

• Inventory management, oversight and coordination of shipping and tracking logistics in the field and within CTMS. 

• Assists GCPM with creation and development of study documents and training material as requested. 

• Completes site setup including DCV introduction and training. 

• Receives, tracks, reviews, manages, and distributes source documents from decentralized visits. 

• Attendance and minute keeping for all assigned KOMs, internal handoffs, vendor teleconferences and Sponsor teleconferences. 

• Establishes and maintains timely Sponsor, CRO, Site, and Central Lab communication as assigned by the GCPM. 

• Supports activities surrounding Decentralized Visits and GCC activities including but not limited to visit scheduling, courier booking, and sample collection and delivery coordination. 

• Tracking and metric reporting as directed by GCPM. 

• Assists with or completes audits of CTMS and GoClinical as directed by GCPM. 

• Assists GCPM with study closeout. Activities may include but are not limited to reconciliation of returned equipment from the field, reconciliation of CTMS and GoClinical. 

• Other duties as assigned. 

Necessary Skills and Abilities: 

• Current knowledge of and the ability to apply ICH/GCP and applicable regulations and guidelines. 

• Competent in the application of standard business procedures including but not limited to SOPs, global regulations. 

• Well organized and able to multitask. 

• Able to work independently and as a team member. 

• Able to take initiative while following directives. 

• Professional, well spoken, articulate. 

• Advanced computer skills including experience with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat application are preferred. 

Educational Requirements: 

• Bachelor’s degree or equivalent experience defined as a minimum of 3 years related, combined experience in education, knowledge and ski