- Maintains regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies throughout the life of the studies. Keeps documents organized and ready for audit and ready for regulatory filings when required;
- Follows the organization's SOPs and provides guidance with staff comprehension and compliance with the SOPs;
- Facilitates communication with the IRB and/or Sponsors.
- Assists with and coordinates the development of clinical trial support documents. Assists with all regulatory filings.
- Ensures IND safety reports are distributed to investigators and the research team for review.
- Assembles reproduces, and archives (hard and electronic copies) technical documents, as appropriate for the document type.
- Collaborates with the research team to facilitate overall protocol operations;
- Identifies problems and issues and takes corrective action and/or escalates appropriately;
- Tracks sponsor and IRB approvals and renewals;
- Reports on the status of clinical trials;
- Generates and reviews reports of regulatory data using appropriate systems;
- Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP;
- Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations;
- Assists in training programs as requested;
- Perform all other duties that may be requested or assigned.
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
- Must possess strong organizational skills, attention to detail, and basic math proficiency.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and assist in implementing solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
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Clinical Research Regulatory Specialist - Decatur, United States - Alcanza Clinical Research
Description
Clinical Research Regulatory Specialist (Remote with travel to Decatur, GA site as needed)Department:
Quality, Regulatory & Source
Employment Type:
Full Time
Location:
Accel Research Sites - Decatur, GA
Reporting To:
Angeline Newcomb
Description
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, and TX.
We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine.
Join us as we continue to grow.
The Regulatory Specialist is responsible for regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance.
The RC maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides training and/or initiates corrective action as required.
Ensures that essential documents are organized, up to date, and in compliance with ICH/GCP guidelines and federal regulations. Assists site-focused reviews, and quality improvement activities.Key Responsibilities
Essential Job Duties:
Minimum Qualifications:
A Bachelor's degree and a minimum of 2 years experience in clinical research, OR an equivalent combination of education and experience, is required.
1+ years of regulatory experience is preferred. Knowledge of GCP/ICH guidelines is required.Required Skills:
