Study Start Up Associate

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities

The Study Start Up is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines

 

Responsibilities

Responsible for supporting the Site Relationship Partners and investigator for Targeted Sites:

 

Clinical Trial Site Activation & Conduct

• Assist with study site activation activities to ensure timely site activation.
• Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
• Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
• Support local IRB workflow from submission through approval and support reporting of updates to safety information.
• Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
• Communicate site approvals to the Site Relationship Partners, Study Start Up Project Managers (where applicable) and relevant study team members.
• Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
• Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
• Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner.
• Assist the Site Relationship Partner with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Support investigator sites, Site Relationship Partners, Study Managers and study teams in preparation for and providing responses to site audits/inspections.

 

Communication

• Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation.
• Maintain ongoing contact and communication with the GSSO team members as needed.
• Respond promptly to GSSO team member and investigator site requests.
• Establish tools for efficient updates to the GSSO Study Team members as needed regarding site status, issues, delays, and approvals.

Clinical Trial Monitoring Support

 

• As needed, support the Site Relationship Partner with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices.
• In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.
• In collaboration with Site Relationship Partner and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.
• In support of Site Relationship Partner, conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.
• Identify and resolve in collaboration with Site Relationship Partner investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues.
• Assist to resolve data queries within required timelines; support database release as