Clinical Trial Specialist, US

Emerald Clinical Trials

6h • Hybrid

About The Position

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. The CTS works closely with the project team to help manage clinical trial feasibility processes, coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs).

Requirements

• College / University diploma / degree; OR at least 2 years related experiences and / or training; OR equivalent combination of education and experience.
• Ability to perform general administrative duties as needed or required.

Nice To Haves

• Exposure to medical terminology preferred.
• Knowledge of ICH/GCP, ethical and regulatory requirements preferred.

Responsibilities

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project.
• Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned.
• Serve as second reviewer for TMF QC.
• May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.
• Assist with/complete end of study TMF filing (including site close out documents), QC and archival.
• Further develop skills in preparing and participating in audit responses.
• Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables.
• Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.
• Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.
• Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable.
• Assist with presenting final feasibility results to PM team and/or Sponsor.
• Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).
• Submit final EDPs to sponsor or CTM/PM as required.

Benefits

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree