Regional Site Start Up II - FSP

Parexel•Southport, NC

About The Position

The Regional Site Start Up (SSU) role leads and delivers site start-up and activation activities across clinical trials. The role is responsible for timely activation of assigned sites, maintaining strong relationships with sites, and collaborating with internal and external teams to achieve study site activation timelines. It provides regional expertise to address geographic-specific needs and support study milestones, requiring strong interpersonal skills, attention to detail, and cross-team collaboration. The role gathers, organizes, and shares essential documents from clinical sites and sponsor-specific documents to meet regulatory and sponsor requirements. It ensures site regulatory packages meet country requirements, TMF standards, and ICH-GCP compliance; supports informed consent form review as requested; and facilitates translation of essential documents for regulatory authority and ethics committee submissions and approvals. The position also maintains site intelligence and activation information in CTMS, updates trackers, keeps site start-up documents filed and inspection ready, and supports inspection readiness. The Regional SSU partners with stakeholders and clinical sites, maintains accurate records of activation progress, and identifies and escalates challenges or delays. It also identifies and implements process improvements and best practices in site start-up activities.

Requirements

Bachelor’s degree, minimum.
3–4 years of experience.
Experience working with the US and Canada.
Demonstrated interpersonal and leadership skills.
Data-driven approach to planning, execution, and problem solving.
Effective verbal, written, and presentation communication skills.
Proactive and self-disciplined, with the ability to meet deadlines, use time effectively, and prioritize.
Demonstrated vendor management experience.
Technical proficiency in trial management systems, including CTMS and TMF, and Microsoft applications including Project, PowerPoint, Word, and Excel.
Experience in the clinical drug development process, including study start-up.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Ability to understand and implement operational strategic direction and guidance for clinical trials, fostering collaboration and trust across diverse teams and stakeholders.

Responsibilities

Deliver individual site activation timelines to plan for assigned sites.
Gather, organize, and share required essential documents from clinical sites and sponsor-specific documents to ensure compliance with regulatory and sponsor requirements.
Collect site intelligence to inform site discussions and maintain site information in CTMS.
Ensure site regulatory packages meet country requirements, TMF standards, and ICH-GCP compliance.
Assist with reviewing Informed Consent Forms (ICFs) as requested.
Facilitate translation of essential documents required in languages other than English for submissions to and approvals from Regulatory Health Authorities and/or Independent Review Boards/Ethics Committees.
Provide regional expertise to address geographic challenges and facilitate site activation.
Serve as the primary point of contact and escalation point for sites; troubleshoot issues and provide strategic solutions to achieve activation timelines.
Update trackers with key study information, risks, and mitigation strategies.
Ensure site start-up documents are filed in the TMF and are inspection ready.
Support inspection readiness activities related to site start-up documents.
Partner with internal and external stakeholders and clinical sites to ensure communication and coordination through the site start-up phase.
Ensure alignment with global and local regulatory requirements.
Maintain accurate records of site activation progress, including document collection, submission status, and timelines.
Identify and escalate challenges or delays in document collection, regulatory submissions, or site activation for resolution.
Identify process-improvement opportunities in site start-up and implement best practices to improve efficiency and effectiveness.
Support stakeholders by addressing concerns promptly and professionally, building positive relationships, and maintaining clear communication.
Contribute to team productivity by maintaining open communication and supporting team members.