0001 - Protocol Specialist

About the role

Bamboohr is seeking a dedicated Protocol Specialist to join our dynamic team in Elizabeth City, North Carolina. This full-time position will play a crucial role in ensuring that our protocols are meticulously developed, implemented, and maintained in accordance with industry standards. The ideal candidate will possess a strong understanding of regulatory requirements and will be responsible for facilitating communication between various stakeholders to ensure compliance and operational efficiency.

Key facts

What you'll do

• Develop, review, and update operational protocols to ensure compliance with regulatory standards and internal policies.
• Collaborate with cross-functional teams to gather input and feedback on protocol development, ensuring alignment with organizational goals.
• Conduct thorough assessments of existing protocols to identify areas for improvement and implement necessary changes.
• Serve as the primary point of contact for protocol-related inquiries, providing guidance and support to team members and stakeholders.
• Organize and facilitate training sessions for staff on new and updated protocols, ensuring comprehensive understanding and adherence.
• Monitor compliance with established protocols and conduct regular audits to identify discrepancies or areas for enhancement.
• Prepare detailed reports on protocol performance and compliance metrics, presenting findings to management and recommending actionable improvements.
• Stay informed about industry trends and regulatory changes, proactively adjusting protocols to maintain compliance and best practices.
• Assist in the development of standard operating procedures (SOPs) that support protocol implementation and adherence.
• Engage with external regulatory bodies and industry organizations to foster relationships and stay updated on best practices.
• Participate in internal and external audits, providing necessary documentation and support to ensure successful outcomes.
• Contribute to the continuous improvement of the protocol development process, identifying efficiencies and streamlining workflows.

Requirements

• Bachelor's degree in a relevant field such as life sciences, healthcare, or regulatory affairs.
• A minimum of 3 years of experience in protocol development or a related role, preferably within a regulated environment.
• Strong understanding of regulatory guidelines and standards applicable to the industry.
• Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely.
• Proven ability to work collaboratively in a team environment and manage multiple projects simultaneously.
• Strong analytical skills, with a keen attention to detail and the ability to identify discrepancies and areas for improvement.
• Proficiency in Microsoft Office Suite and experience with protocol management software.
• Ability to work independently and take initiative in problem-solving and decision-making.
• Familiarity with quality assurance processes and compliance auditing is a plus.

Nice to have

• Certification in regulatory affairs or a related field (e.g., RAC, CQA).
• Experience in clinical research or a healthcare setting.
• Knowledge of electronic document management systems and data analysis tools.
• Previous experience working with external regulatory agencies.
• Familiarity with project management methodologies and tools.

Skills & tools

The successful candidate will be proficient in using various software tools for document management, data analysis, and project tracking. Strong skills in Microsoft Office Suite (Word, Excel, PowerPoint) are essential, along with experience in specialized protocol management systems. Familiarity with data visualization tools and electronic health record systems will be advantageous.

Practical notes

This position is based in Elizabeth City, North Carolina, and may require occasional travel for training sessions, audits, or industry conferences. The salary for this role is competitive and will be determined based on the candidate's experience and qualifications. Bamboohr is committed to fostering a diverse and inclusive work environment and encourages applications from individuals of all backgrounds. Visa sponsorship is available for qualified candidates who meet the necessary requirements.

META

Company: Bamboohr

Title: 0001

Protocol Specialist

Listed

location: Elizabeth City, North Carolina

Job type: full_time

Apply URL: https://asgi.bamboohr.com/careers/306

About the company

The Asynchronous Server Gateway Interface (ASGI) is a calling convention for web servers to forward requests to asynchronous-capable Python frameworks, and applications. It is built as a successor to the Web Server Gateway Interface (WSGI).