We are looking for a Clinical Site Network Director to join our team of researchers for our multiple locations. Role will be based at our Atlanta site. The ideal candidate will have Senior Clinical Research Coordinator Experience and strong management skills.

* 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:

• Leadership & Management:

• Oversee day-to-day operations of multiple clinical research sites, ensuring efficient workflows, high-quality data collection, and optimal patient care.

• Lead, mentor, and develop site managers and research staff, fostering a collaborative and high-performing team environment.

• Ensure alignment of site performance with organizational goals and sponsor expectations.

• Strategic Planning:

• Develop and implement short- and long-term strategies to enhance the efficiency, productivity, and profitability of clinical sites.

• Identify growth opportunities and expand the network by securing new trials and optimizing site performance.

• Collaborate with senior leadership to set performance goals, budgets, and key metrics for each site.

• Operational Excellence:

• Standardize procedures across all sites to maintain consistency in research processes, quality, and compliance.

• Oversee resource allocation, assist Human Resources with site staffing, and the support implementation of clinical trial management systems (CTMS).

• Ensure that all clinical trials are conducted according to GCP, FDA, and ICH guidelines, as well as sponsor and protocol requirements.

• Business Development:

• Build and maintain relationships with key stakeholders, including sponsors, CROs, investigators, and partners.

• Assist Finance in representing the network in contract negotiations with sponsors and partners, ensuring favorable terms for site operations and business growth.

• Develop marketing strategies to attract sponsors and expand the portfolio of clinical trials.

• Regulatory Compliance & Quality Assurance:

• Ensure compliance with all relevant regulations and ethical guidelines, including FDA, GCP, and local IRB requirements.

• Oversee internal and external audits, ensuring that findings are addressed and corrective actions are implemented across sites.

• Establish quality control processes to monitor the performance of ongoing trials and ensure data integrity.

• Patient Recruitment & Retention:

• Develop and implement patient recruitment and retention strategies to meet enrollment goals for clinical trials.

• Ensure a patient-centric approach across all sites, with an emphasis on patient safety and satisfaction.

REQUIREMENTS:

• BSN with post-secondary degree preferred or PharmD

• Minimum of 7-10 years of experience in clinical research, with at least 3-5 years in a leadership or management role overseeing multiple sites.

• Proven experience in clinical trial operations, site management, and business development.

• Exceptional leadership, communication, and organizational skills.

• Strong knowledge of GCP, FDA, and ICH guidelines and regulations, certification from CRP from SOCRA or ACRP highly desirable

• Ability to travel between locations as required.

• Please note that due to the immunocompromised nature of our patients COVID and flu vaccinations are REQUIRED

We are looking for a Clinical Site Manager to join our team of researchers in our Hillsborough, NC location. The ideal candidate will have Senior Clinical Research Coordinator Experience and strong management skills.

* 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.

Responsibilities:

• Have in-depth knowledge of all active studies at RDR NC site.

• Serve as a resource for the clinical team to help navigate through the study protocol, problem-solve any issues that may arise, navigate new studies and anticipating problems before they arise

• Responsible for managing day to day functioning of the (CRC/RS/RA) research team

• Attend all relevant study meetings to help clinical staff project manage and prioritize projects and tasks

• If needed, serve as primary CRC for studies to provide direct oversight and mentorship for junior staff

• Assist the team by managing clinical evaluators and clinical vendors (such as anesthesia, PT, psych)

• Assist/clinical team in communications with medical monitors, CRA and other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget.

• Works directly with the investigators on planning and coordination of clinical trials from Start-Up to study closure.

• Supports quality assurance on study documents to ensure that studies are being conducted effectively and with strong adherence to protocols and standardization.

• Directly manage Research Assistants and Research Specialists and their work to assist in their growth towards becoming a CRC.

• Directly manage CRCs and their work to assist in their growth towards becoming a CRC II.

• Responsible for onboarding via a hands-on mentorship approach to assess and train new RDR clinical staff, including contract and part-time staff

• Assist in creating and maintaining Standard Operating Procedures

• Report to the Head of Research

• Evaluates all CRCs, RSs, and RAs on a bi-annual and as needed basis addressing issues in real-time

REQUIREMENTS:

• Bachelor’s degree in clinical related field, post-secondary degree preferred

• 6 - 8 years experience in the clinical research field, including management of clinical research teams.

• Detail-oriented, excellent verbal and written communication skills.

• Certification from CRP from SOCRA or ACRP

• Please note that due to the immunocompromised nature of our patients COVID and flu vaccinations are REQUIRED

* 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.

Senior Backend Engineer (NestJS, GCP, TypeORM)

Responsibilities:

• Architect, develop, and maintain robust backend systems using NestJS and TypeORM.

• Lead the migration of existing Node.js applications to the new NestJS architecture.

• Design and implement efficient database schemas and interactions using TypeORM and MySQL.

• Build and deploy applications on Google Cloud Platform's Compute Engine, utilizing Docker containers and orchestration tools like Kubernetes.

• Collaborate with front-end developers to integrate with Angular 18 applications through well-defined APIs.

• Troubleshoot and resolve issues in development and production environments.

• Champion best practices for backend development, including security, performance optimization, and scalability.

• Write clean, well-documented, and testable code, ensuring high code quality through code reviews and best practices.

• Troubleshoot and resolve issues in development and production environments.

• Design and deploy SaaS applications across multiple regions globally, ensuring high availability and low latency.

• Design systems with a focus on performance, redundancy, and fault tolerance to ensure a reliable user experience.

• Contribute to the security of our systems by performing penetration testing and identifying vulnerabilities.

• Stay up-to-date with the latest security threats and vulnerabilities.

• Mentor junior engineers and share your expertise in NestJS, TypeORM, and GCP.

• Knowledge of ​​HAPI FHIR Tools or integration with Cloud based FHIR Servers is a plus

• Data Migration & Integration

• Developing and executing data migration strategies from diverse sources like databases, APIs, and other platforms.

• Building and maintaining stable data integrations to ensure ongoing synchronization between customer systems and our platform.

• Collaborating with internal teams to understand data requirements and ensure data integrity.

Qualifications:

• 5+ years of experience in backend software development.

• Strong proficiency in Node.js and experience with NestJS or a strong desire to learn it quickly.

• Experience with Object-Relational Mapping (ORM) libraries, preferably TypeORM.

• Solid understanding of relational databases (MySQL) and SQL.

• Extensive experience with containerization technologies (Docker) and container orchestration (e.g., Kubernetes).

• Strong understanding of Google Cloud Platform (GCP) and hands-on experience with Compute Engine, networking, and storage services.

• Excellent problem-solving and debugging skills.

• Strong communication and collaboration skills.

• Knowledge of common web security vulnerabilities (OWASP Top 10) and penetration testing methodologies.

• Experience with security auditing and vulnerability assessment tools.

• Conduct pre-visit home assessment phone calls with the study participant’s families and schedule the home health visits

• Travel to patients’ homes and conduct research assessments and questionnaires according to the study requirements

• Administer Investigational Product via IV infusion

• Monitor patient vitals

• Test urine before and after dosing

• Monitor and evaluate patient response to Investigational Products

• Fill out and submit home health visit documentation to our team.

REQUIRES valid RN License, prefer Compact RN License