Job description

Southern California Research Center is a private research center. We are seeking to hire an experienced Clinical Research professional to be responsible for the regulatory and IRB-related activities of our active research center. The position will be based in Coronado, California.

Responsibilities include, but are not limited to:

• Regulatory and IRB start-up of clinical trials
• Establish and maintain regulatory/investigator site files for ongoing clinical trials
• Make IRB submissions in a timely manner
• Maintain IRB communications
• Monitor study records and training of staff members
• Implement site’s SOPs
• Ensure compliance and adherence with GCP/ICH, HIPAA, and other current applicable healthcare and research regulations and guidances
• Other special projects, when applicable

Qualifications and qualities that are important for this position include:

• Minimum 3-year experience in establishing, processing and maintaining investigator site files (electronic and/or paper-based systems)
• Minimum 3-year experience in local and/or central IRB submissions and correspondence
• Minimum 3-year experience in pharmaceutical-sponsored clinical research/trials setting
• Proficient and experienced in GCP/ICH principles, FDA CFR, and other applicable regulations
• Ability to foster a culture of teamwork, lead, and grow the center
• Excellent organizational and time-management skills
• Ability to multi-task and perform well in stressful situations
• Professional and approachable demeanor
• Experience in clinical research in California is preferred
• Bilingual in English/Spanish or English/Arabic is preferred

Please do not contact the office directly. Qualified candidates will be contacted directly by the hiring team.

Job Type: Full-time

Pay: From $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Coronado, CA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• pharmaceutical-sponsored clinical research/trials setting: 3 years (Preferred)
• Regulatory: 3 years (Preferred)
• IRB: 3 years (Preferred)

Language:

• Spanish (Preferred)
• Arabic (Preferred)

License/Certification:

• GCP Certification (Preferred)

Work Location: In person

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.