Remote Planning Specialist

6001 Perth SVT

Posted 4 days ago

Job Description

Your Gateway to a Rewarding Career in Travel

Are you passionate about your clients and delivering outstanding customer service? Scenic Voyages Travel is on the lookout for a Remote Planning Specialist to enhance our dedicated team. We pride ourselves on creating a professional, supportive, and collaborative environment, where you can grow, build lasting relationships, and continuously learn.

What We Offer:

- Multiple Training Opportunities: We believe in nurturing our teams potential with extensive training support.
- Supportive Community: Engage in our group forum and monthly virtual gatherings to share ideas, seek assistance, and foster a sense of belonging.
- Flexible Working Arrangements: Choose between part-time or full-time roles, all with the convenience of remote work.

Attractive Benefits:

- Employee discounts to fuel your passion.
- Flexible schedule for a better work-life balance.
- Career development assistance to advance your career.

Your Role:

- Deliver professional customer service in-person, via phone, or email.
- Assist clients in planning seamless experiences.
- Prepare and manage client itineraries and needs.
- Maintain meticulous records in line with government regulations and company policies.
- Organize and manage files effectively.

Who We Are Looking For:

- A responsible, self-driven individual with a strong work ethic and professional demeanor.
- Someone who thrives both independently and as a team player.
- A detail-oriented, organized professional with exceptional communication skills.
- Coachability and a keenness to learn and grow within the industry.

Embark on a journey today,



where your career is as rewarding as the experiences you create for others.

Key Accountabilities

- Clinical Trial Site Activation:
- Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation
- Provide support to resolve issues or concerns and timely escalation of site issues where applicable
- Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements
- Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)
- Support investigators sites with local IRB workflow from preparation, submission through approval
- Assist with the preparation, handling,



and distribution of clinical documentation and reports according to the scope of work and standard operating procedures
- Support and implement activities in Shared Investigator Platform (SIP) to align with the client's strategy as it relates to the role

- Clinical Trials Conduct:

- Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct
- Ensure maintenance of IRB/Ethics and other committees' activities as applicable
- Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

- Communication:

- Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
- Provide functional updates on a country and site level as required
- Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
- Disseminate central or local ethics approval to study team and Investigator sites where applicable
- Communicate local sites approvals to study team members and stakeholders

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