Clinical Research Associate

Position Overview:

As a Clinical Research Associate at Alume Biosciences you will aid in operating multiple clinical trials involving a nerve visualization agent for use in fluorescent guided surgery. The ideal candidate is detail-oriented, possesses exceptional organizational skills, and understands the importance of maintaining a high level of professionalism in both internal and external interactions.

Key Responsibilities:

1. Travel: Candidate must be willing and able to travel to clinical sites and secure credentialing that includes multiple vaccinations, TB testing, radiation testing, background check clearance, and competency in the subject matter. Candidate must be willing to attend surgical cases in an operating room and adhere to hospital guidelines as a representative of Alume.

2. Communication: Manage communication with vendors and site personnel professionally and with subject matter expertise.

3. Data Management: Responsible for oversight of site activities including query management and site communications for QC/QA of Trial data.

4. Vendor Management: Coordinate and manage vendors to the company. Provide oversight of CRO activities and other clinical vendors to ensure study quality meets regulatory requirements and that data quality is accurate and accurately represents the interests of Alume.

5. Documentation: Compilation of Trial Master File documents including briefing and supporting documents. Coordination and planning for document management and preparation. Development and execution of clinical study plans (data management, IRB compliance management, and internal clinical study communication).

6. Team Support: Collaborate closely with the CFO, CEO, and Chief Medical Officer, working on execution and oversight of clinical trials.

7. Confidentiality: Handle sensitive information with discretion and maintain the highest level of confidentiality in all matters.

8. Meeting Coordination: Assist with preparation of study deliverables, weekly reports, Alume presentations, and data spreadsheets with visual aids.

9. Office Etiquette: Uphold a professional atmosphere when in the office, including maintaining a neat and organized workspace and adhering to company dress code standards.

10. Problem-Solving: Demonstrate the ability to identify challenges and proactively find solutions while maintaining a calm and professional demeanor.

11. Optional: Assist in development of clinical program in efforts of expansion to other indications with consultation, discussion, medical writing, database build, IRB document preparations, and all other concepts from communication with study teams to adaptation of current protocols.

12. Optional: Review analytics and data to perform internal analysis of subsets of data in order to keep teams appraised of emerging issues. Tasked with conceptualizing solutions and offering creative ideas in light of budget management and capabilities.

Qualifications:

• Proven experience as a Clinical Research Associate, Clinical Trial Manager or in a similar role.

• Exceptional organizational and time-management skills.

• Strong written and verbal communication skills.

• Proficient in office software (e.g., Microsoft Office Suite).

• Ability to handle confidential information with discretion.

• High level of professionalism in appearance and conduct.

Job Type: Full-time

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: Hybrid remote in San Diego, CA 92121