We’re Hiring!

About Gooseberry Research:

At Gooseberry Research, our mission is simple but transformative: to make clinical trial participation more accessible, convenient, and patient-focused, ultimately accelerating the development of life-changing therapies for those in need. We leverage decentralized clinical trial models, which allow patients to participate in studies from their homes, instead of traveling to research sites. We believe that no one should be excluded from the opportunity to participate in clinical research simply because of geographic barriers or logistical challenges. We conduct training of clinical research staff at our central site in Atlanta, GA and deploy them to patient locations thus providing rare disease patients with access to a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are seeking a highly motivated and detail-oriented Regulatory Specialist to become an integral part of our GBR team of research professionals. This pivotal role involves guiding and overseeing the development and implementation of regulatory strategies for clinical trials conducted by Gooseberry Research. This role will provide essential support to our operations team.

Position Summary:

The Regulatory Specialist is responsible for overseeing and managing all aspects of regulatory compliance within the organization, ensuring adherence to applicable federal, state, and local laws and regulations related to both home health services and clinical research. This includes the development, implementation, and maintenance of compliance policies and procedures (SOPs), risk assessments, staff training, internal audits and operational compliance. This position also manages the Master Training Log, Delegation of Authority (DOA) Matrix and Onboarding Matrix, ensuring that all required training and staff certifications are current and documented appropriately. The ideal candidate will have a strong understanding of home health operations, clinical research regulations (GCP, FDA), and a thorough understanding of clinical research workflows, data collection and documentation practices.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Key Responsibilities:

Regulatory & Compliance Oversight:

• Ensure organizational compliance with applicable laws and regulations including FDA, OHRP, ICH-GCP, HIPAA, and relevant state home health regulations.

• Maintain up-to-date knowledge of regulatory requirements related to decentralized trial models and home-based clinical research activities.

• Develop and implement scalable, risk-based compliance strategies to support clinical trial execution in a home setting.

• Monitor changes in regulatory requirements and integrate updates into GBR policies and workflows.

Training & Personnel Oversight:

• Maintain GBR’s Master Training Log, ensuring all team members have completed required training (e.g., GCP, protocol-specific, HIPAA, IATA) prior to performing study tasks.

• Manage and routinely update the Delegation of Authority (DOA) Matrix to reflect current study assignments and role-based responsibilities.

• Create and manage Training Logs and DOA Logs for each study to ensure compliance and documentation integrity.

• Oversee the Onboarding Matrix to ensure proper tracking and documentation of required onboarding activities and certifications for new and existing employees.

• Coordinate periodic training refreshers and document retraining as required by protocol, SOPs, or regulatory updates.

• Design and deliver ongoing compliance and regulatory training to clinical and operational staff, including home research professionals (HRPs).

• Ensure training materials reflect current regulations and organizational policies, with emphasis on real-world DCT scenarios.

Policy & SOP Development:

• Draft, update, and enforce compliance-related SOPs and policies that reflect regulatory and operational requirements for DCTs and home health.

• Collaborate with clinical operations, QA, and executive leadership to incorporate compliance principles into daily operations.

• Ensure SOPs support decentralized workflows and align with sponsor expectations, industry standards, and ethical conduct of research.

Internal Audits & Risk Management:

• Plan and conduct internal audits across GBR’s clinical, regulatory, and home health activities to ensure compliance with SOPs and regulatory standards.

• Conduct a weekly review and audit of GBR’s Master Quality Issue Log/Tracker Matrix, ensuring issues are accurately documented, investigated, and resolved within required timelines.

• Create and maintain CAPAs (Corrective and Preventive Action Plans) in response to audit findings or deviations.

• Draft and manage Notes to File (NTFs) to document protocol deviations or clarifications in a compliant and traceable manner.

• Analyze trends from audit findings and quality issues to drive continuous improvement across departments.

• Coordinate and support external audits and inspections, ensuring timely resolution of findings.

Operational Support & Collaboration:

• Provide regulatory and compliance guidance during study start-up, protocol review, and vendor or staff onboarding.

• Support regulatory documentation and site file management throughout the trial lifecycle.

• Collaborate closely with QA and Clinical Operations teams to embed a culture of quality and compliance into everyday operations.

• Review and approve essential regulatory documents and study materials for compliance prior to implementation.

Documentation & Binder Management:

• Organize and maintain GBR’s essential binders, ensuring all content is current, accurate, and audit-ready:

• Regulatory Binders – with IRB approvals, protocol versions, investigator documentation, etc.

• Study Binders – including protocol-specific logs, visit documentation, lab requisitions, study communications, etc.

• Personnel Binder – containing credentials, training certifications, licenses, and CVs for all HRPs

• Site Support Request Binder – tracking requests and assignments for each study sites

• Calibration Binder – with current calibration records and certificates for all equipment and devices used in research.

Quality Management and Improvement:

• Develop, implement, and maintain the company’s Quality Management System (QMS).

• Lead quality improvement initiatives across both home health operations and compliance operations.

• Analyze performance data to identify trends, deficiencies, and opportunities for improvement.

• Oversee the development and monitoring of quality indicators and key performance metrics (KPIs).

Clinical and Operational Auditing:

• Conduct regular internal quality audits to ensure compliance with clinical standards, protocols, and company policies.

• Co-ordinate audit activities for sponsor / regulatory / external inspections.

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• Educational Qualifications: Bachelor’s degree in life sciences, pharmacy, or a related field.

• Professional Experience: 2-5 years of experience in Quality Assurance (QA)/Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on clinical trials.

• Regulatory Strategy and Submission Expertise: Demonstrated experience in leading regulatory strategy and submissions for clinical trials across multiple trials.

• Regulatory Knowledge: In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).

• Leadership Skills: Strong leadership skills with experience in managing and developing teams.

• Communication and Interpersonal Skills: Excellent communication, negotiation, and project management skills.

• Adaptability: Ability to work effectively in a fast-paced, cross-functional environment.

• Project Management: Proven ability to manage multiple projects and meet deadlines.

• Vaccination Requirement: Please note that due to the immunocompromised nature of our patients, initial covid vaccination and annual flu vaccinations are required.

Work Location: In person

Job Type: Full-time