About Us

Pinnacle Fertility is a leading fertility care platform dedicated to fulfilling dreams by building families. We support a nationwide network of fertility clinics, providing innovative technology, compassionate patient care, and comprehensive fertility treatment services to ensure a seamless, high-touch experience for every family. Learn more about us at www.pinnaclefertility.com.

About the Role

The Donor Cycle & FDA Compliance Coordinator role is an ideal opportunity for a compassionate, detail-oriented individual seeking to make a meaningful impact in the field of reproductive health. You will play a vital role in supporting patients undergoing Third Party Reproductive (TPR) services, guiding them through their treatment journey, and coordinating care with a multidisciplinary team to ensure an exceptional experience. You will also examine records, reports, operating practices, and documentation to ensure FDA compliance and adherence to internal controls and procedures.

We are seeking a Donor Cycle & FDA Compliance Coordinator to join our dedicated team at Seattle Reproductive Medicine in Seattle, WA. This is a full-time hybrid or remote position working Monday through Friday, from 8:30 AM to 5:00 PM.

Key Responsibilities:

Serve as the primary point of contact for patients undergoing Third Party Reproductive (TPR) services.
Guide patients through their treatment plans, educating them on procedures, testing, medications, and follow-up care.
Create, maintain and ensure adherence with SOPs for FDA compliance.
Create and deliver training materials for FDA training of patient navigators.
Be the point of contact for questions about the FDA qualification process and complicated DEDs.
Handle complicated DED issues and coordinate with the doctors or lab director as needed.
Perform random audits of DEDs to ensure FDA guidelines are being followed.
Assist remotely with FDA inspections and implement any needed changes that arise from inspections.
Coordinate TPR treatment per provider directives.
Schedule appointments, tests, referrals, and ensure all necessary follow-ups are completed.
Communicate regularly with healthcare providers and administrative teams to support continuity of care.
Maintain accurate documentation in the electronic medical record (EMR) system.
Provide emotional support and advocate for patient needs throughout the treatment process.
Monitor patient progress, track compliance, and follow up on missed appointments.
Participate in team meetings, quality improvement initiatives, and assist with special projects as assigned.

Position Requirements:

Education: Bachelor’s degree in nursing, healthcare, social work, or a related field.

Experience: Minimum of 10 years RN experience coordinating fertility treatments. 5+ years of TPR and FDA experience preferred.

Skills:

Strong knowledge of healthcare systems, insurance processes, and patient advocacy.
Excellent communication, organizational, and problem-solving skills.
Excellent time management skills with the ability to work independently, multi-task, and prioritize work.
Proficiency in using electronic medical records (EMR) and healthcare software.
Proficiency using Microsoft Office, including Excel and Word.
Empathy and a patient-focused approach, with the ability to work collaboratively in a multidisciplinary team.

Compensation & Benefits:

Hourly Rate: $40.00 - $50.00 per hour (final offers based on experience, skills, and qualifications).

Benefits: Comprehensive healthcare, dental, life, and vision insurance. Additional benefits include generous paid time off (PTO), paid holidays, and a retirement savings program. Further details will be provided during the interview process.

Diversity & Inclusivity at Pinnacle Fertility

At Pinnacle Fertility, we are committed to fostering a diverse and inclusive environment. We serve everyone, regardless of gender, sexual orientation, race, ethnicity, or religion. Just as we celebrate the diversity of our patients, we value the diversity within our team. We believe diversity drives innovation, enhances patient care, and creates opportunities for growth. We are proud to be an equal-opportunity employer and encourage applicants from all backgrounds, abilities, and life experiences to apply.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Seattle Reproductive Medicine Inc PS

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