Clinical Site Specialist
2 months ago
Position Overview:
We are seeking a skilled and dedicated Clinical Site Specialist to join our team. The ideal candidate will have substantial experience in the medical device industry, specifically within orthopaedics, and must be adept at handling orthopaedic implants and coordinating their delivery to hospital sites. This role requires a keen understanding of FDA regulations and the ability to engage effectively with the FDA.
Above all, the suitable candidate must exhibit a a strong passion for patient care, with a commitment to improving and changing patients' lives
Key Responsibilities:
- Managing the setup of new clinical sites to implement a novel orthopaedic treatment
- Traveling interstate to visit potential clinical sites and ensure successful implementation.
- Engaging with hospital sites to oversee the delivery and handling of orthopaedic implants.
- Collaborating with regulatory bodies and maintaining compliance with HIPAA and FDA regulations.
- Providing in-theatre (operating room) support and training as a surgical representative during the implementation phase.
Qualifications:
- This role is a US based remote role with high levels of travelling required.
- A strong background in the medical device industry is required. Experience in orthopaedics strongly favoured.
- Proven track record in liaising between clinical bookings and coordinating the supply of devices into hospital sites.
- Experience dealing with the FDA and in-depth knowledge of relevant regulations.
- Completion of in-theatre training as a surgical representative is highly preferred.
Training and Development:
- Initial training will be provided in Sydney, Australia. The selected candidate should be willing to travel to Sydney for the training program.
Skills and Attributes:
- Excellent communication and interpersonal skills.
- Strong organizational and multitasking abilities.
- Detail-oriented with a strong commitment to compliance and regulatory standards.
- Ability to work independently as this is a role with high degrees of autonomy.
Application Process:
Interested candidates should submit their resume along with a cover letter detailing their relevant experience and why they are the ideal fit for this role. We look forward to welcoming a new team member who is as passionate about advancing orthopaedic treatments as we are. If you meet the qualifications and are ready to take on this exciting challenge, we encourage you to apply.
Compensation:
The annual salary for this position ranges from $65,000 to $85,000, commensurate with the candidate's level of experience and qualifications.
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