Clinical Trials Data and Project Coordinator

About the position: This role serves as a liaison between the Clinical Trials department, other Arkana departments, and external partners to ensure the efficient and compliant launch and execution of studies. The role provides guidance to personnel, manages various study operations, ensures regulatory adherence, and supports the development of study documents, data processes and communication during trial milestones (i.e., launch, interim lock, amendments, and closing). The position requires strong organizational, communication, and analytical skills, with the ability to work both independently and collaboratively.

What you'll do: 

• Attend clinical trial related study meetings during study launch, as well as participation in any additional planning and development related activities during study milestones such as interim locks, amendments and closings
• Oversee internal and external workflows throughout the launch of the study; manage communication and updates regarding progress; promote effective and efficient operation and use of resources
• Provide guidance and training to Arkana personnel engaged in studies to ensure compliance with protocols and overall study objectives (including any updates to protocols or processes)
• Manage data transfer agreement (DTA) creation, implementation, execution as well as any amendments in collaboration with the sponsor’s data team and Arkana’s data and build team
• Work with study coordinator to create study specific documents such as protocol forms, req forms, biopsy and procedural manuals, and case report forms (eCRFs)
• Partner with internal and external shipping teams to set up logistical details for kit shipments and sample returns
• Other duties as assigned

You should have: 

Education:          Bachelor’s degree

Experience:         Minimum 4 year's experience in research project management or research related data management         

Other job duties: Knowledge of EDC preferred but not required  

System Experience: Some experience in REDCap, RAVE, SDTM, and DTAs but not required

Schedule: Monday-Friday 8am-5pm, onsite at the main office in Little Rock, Arkansas.

This is an onsite position at our main office in Little Rock, Arkansas, applicants must live within 1 hour drive of the main office in Little Rock.