As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. Rare Disease Research with its affiliate Gooseberry Research provides research home health services to our patients. We are 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 looking for a Regulatory Manager who has at least 2-3 years of experience with the conduction of clinical research and regulatory experience to join our wonderful team of motivated research professionals in our home health division.
* 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:
- Create and update Standard Operating Procedures (SOPs) for a research home health service that involves establishing clear, detailed, and organized guidelines to ensure consistency, quality, and compliance in service delivery.
- Assists the home health team in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
- Develop protocol training manuals, visit source documents and other materials or tools to assist the home health team to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Assists with training and mentoring home health RNs.
- Ensure completeness of study documentation by home health RNs in accordance with ALOAC compliance.
- Collects or coordinates collection and shipping of IP and study specimens guiding research nurses during home visits
- Collaborates with the Director of Home Health and institution to respond to any audit findings and implement approved recommendations.
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Regulatory Compliance: Ensure adherence to regulatory requirements set forth by governing bodies such as the FDA, ICH-GCP, and institutional review boards (IRBs)
- Documentation Reviewal: Review regulatory documents such as study protocols, informed consent forms, investigator brochures, and annual reports to regulatory agencies and IRBs from Home Health nurses for ALOAC compliance and completion of documents.
- Ability to exercise independent judgment and discretion.
- Monitoring and Auditing: Assist when needed in internal and external audits by maintaining accurate and organized regulatory files and providing requested documentation and information
- Communication: Serve as a liaison between research teams, regulatory authorities, and sponsors, providing updates on regulatory requirements and ensuring timely submission of documents
- Record Keeping: Maintain comprehensive and up-to-date regulatory files and databases, including tracking submissions, approvals, and correspondence related to each clinical trial based on Home Health nurse study.
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:
- Secondary degree in social science, health science or related field preferred
- Alternative educational backgrounds may be accepted (i.e., LPN, Medical Assistant, etc) in combination with previous CRC experience
- Phlebotomy skills a plus
- CCRP from SOCRA or ACRP preferred
- Must have GCP, IATA, ALCOAC training
- 3 years of experience in progressively growing CRC roles in clinical trial settings or regulatory affairs required
- Experience training/mentoring RAs, Home Health RN’s and other research team members
- Some travel for home health visits may be required
- Fully vaccinated against COVID-19 and willing to receive annual flu vaccination
- Excellent organizational, communication and computer skills
- Meticulous attention to detail
- Ability to work independently and collaboratively in a diverse and fast-paced environment
- BLS/CPR training upon hire date
Job Type: Full-time
Pay: $65,000.00 - $85,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- No nights
- No weekends
Education:
Experience:
- Clinical Trials: 3 years (Required)
- Clinical Research Coordinator: 3 years (Required)
Ability to Commute:
- Atlanta, GA 30329 (Required)