Clinical Research Regulatory Specialist

ActivMed Practices & Research, LLC.; Burlington; On-site; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Health savings accounts

Supplemental insurances

401k plan with safe harbor match

Job summary

Alcanza Clinical Research is seeking a Regulatory Specialist to ensure GCP/SOP compliance across multiple sites. You will manage regulatory documents, liaise with IRB and sponsors, and lead quality control and staff training on regulatory processes.

Responsibilities include maintaining study files, coordinating regulatory filings, distributing safety reports, and supporting audits to keep essential documents up-to-date and audit-ready. A strong attention to detail is essential.

Qualifications

• Bachelor’s degree and a minimum of 2 years in clinical research; 1+ year regulatory experience preferred.
• Knowledge of GCP/ICH guidelines is required.
• Excellent documentation and compliance focus.
• Ability to communicate with IRB, sponsors, and study teams.

Responsibilities

• Maintains regulatory documents/binders for audits and regulatory filings when required.
• Follows SOPs and provides guidance to staff on compliance.
• Facilitates communication with IRB and Sponsors.
• Assists with development of clinical trial support documents and regulatory filings.
• Ensures IND safety reports are distributed for review.
• Assembles and archives technical documents as appropriate.
• Collaborates with the team to support protocol operations.
• Tracks sponsor and IRB approvals and renewals.
• Generates and reviews regulatory data reports.
• Ensures compliance with federal regulations and ICH/GCP.

Skills

Strong organizational skills

Attention to detail

Written & verbal communication

Interpersonal skills

Independent work ability

Integrity & dependability

HIPAA compliance awareness

Education

Bachelor's degree or equivalent in related field

2+ years clinical research regulatory experience

Tools

Microsoft Office

EHR systems

Web applications

Typing 40 wpm

Job description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, and Puerto Rico. 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.

Essential Job Duties

• 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.

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

• 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.

Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.

We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.

Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.

Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.