Contractor RA_Georgia

Tigermed; Georgia; On-site; USD 90,000 - 130,000; Full time

Job summary

Tigermed in the United States (Georgia) seeks a Regulatory Start-Up specialist to support feasibility, regulatory submissions, and site activation for clinical trials. You will liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, and sponsors to enable rapid trial starts, develop feasibility questionnaires, and coordinate with cross-functional teams to secure client approvals.

The role involves reviewing CDAs, tracking timelines, providing safety and quality assurances, assisting

Responsibilities

• Feasibility: Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other teams and sponsors to enable rapid trial start-up.
• Regulatory activities: Plan, organize, compile, progress, track and submit regulatory submissions timely; review translations and QC dossiers as needed.
• Site Start-up: Manage site activation resources, oversee regulatory requirements, coordinate global staffing plans, and support HR-related tasks within projects.
• Report: Record hours, participate in meetings and trainings, and support project progress communication.

Job description

Gain and apply knowledge and experience within RSU global (country / local, when applicable)

regulatory and legal requirements related to site activation activities

Responsibilities:

1- Feasibility:

• Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• Coordination of the development of the feasibility questionnaire for a study. Seeks expertise from applicable supporting functions (Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
• Support PM/Legal in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template and feasibility questionnaire to sites distribution, together with the head of the department for a study.
• Review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.
• Sends regulatory packages to selected sites and documents/follows-up with sites on the start-up process.
• May be assigned to lead or review and approve strategy, content and costing of proposals in collaboration with Business Development, Project Management, and other functional areas.
• May provide operational leadership to bid defense meetings and may attend bid presentations for key accounts. Proactively interact cross-organizationally to develop and learn about emerging business, therapeutic, and operational strategies that improve service to our internal and external customers.
• May help develop and implement cross-functional initiatives for continuous process and quality improvements.

3- Regulatory activities

• Liaise with regulatory specialists’ colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis.
• May act as a contact point for translation review of submissions documents such as application, protocol and protocol synopsis, ICF, labels etc.
• Where required provide local QC of submission dossiers prior to dispatch.
• Effectively communicate to relevant project team members the status and action plans concerning submissions.
• Identify risks and generate mitigation strategies.
• When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers.
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations.
• Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database.
• Advise the project team about appropriate regulatory strategies.
• Review and make recommendations on all relevant documentation e.g. IP labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements.
• Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory and Start-Up department.
• Provide advice to the Regulatory and Start-Up department on interpretation of new legislation, guidance and directives.

4- Site Start-up

• Responsible for management of site activation resources in assigned project in collaboration with Functional Leads, HR and/or Finance.
• Oversight of regulatory requirements for Site Activation activities ensuring that these are managed effectively and appropriately reflected in the project plan.
• Support in coordinating with internal departments to ensure global staffing plans and forecasts are accurate, adequate and agreed by CRO functional groups and customers.
• In collaboration with HR Partners, manage direct report appraisals, development, hiring and termination within assigned project.
• Occasionally perform site activation “hands on” functional tasks within assigned project when successful delivery depends upon it.
• Delegates whilst retaining ownership.

5- Report

• Record working hours in Tigermed’s/Opera CRO system and report project process and progress with the established frequency, according to the requirement of Project Management Department.
• Participate in internal meetings
• Participate in allocated trainings
• Any other task given by the direct superior.