Clinical Research Regulatory Specialist

Alcanza Clinical Research•Lake Mary, FL

About The Position

Alcanza is a growing multi-site, multi-phase clinical research company with locations across several U.S. states and Puerto Rico and studies spanning Phase I–IV and multiple therapeutic areas. The Regulatory Specialist is responsible for regulatory compliance and documentation, quality control, and organizational training related to GCP and SOP compliance. The role maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance. The specialist identifies deficiencies and discrepancies and provides training or initiates corrective action as needed. The role also ensures essential documents are organized, current, and compliant with ICH/GCP guidelines and federal regulations, and assists with site-focused reviews and quality-improvement activities.

Requirements

Bachelor’s degree and at least 2 years of clinical research experience, or an equivalent combination of education and experience.
Knowledge of GCP/ICH guidelines.
Proficiency with Microsoft applications, email, electronic health records, and web applications.
Ability to type at least 40 words per minute.
Strong organizational skills, attention to detail, and basic math proficiency.
Well-developed written and verbal communication skills.
Interpersonal and listening skills, with the ability to work independently and with coworkers, subjects, managers, and external customers.
Ability to handle multiple tasks and adapt to changes in workload and priorities.
Professionalism, respect for others, self-motivation, and a strong work ethic.
High degree of integrity and dependability.
Ability to work under minimal supervision, identify problems, and assist in implementing solutions.
Ability to handle sensitive information confidentially and professionally, in compliance with HIPAA guidelines.

Nice To Haves

At least 1 year of regulatory experience.

Responsibilities

Maintain organized regulatory documents and binders throughout the life of research studies, keeping them ready for monitoring, auditing, and regulatory filings.
Follow organizational SOPs and guide staff in understanding and complying with them.
Facilitate communication with the IRB and/or sponsors.
Assist with and coordinate development of clinical trial support documents and regulatory filings.
Ensure IND safety reports are distributed to investigators and the research team for review.
Assemble, reproduce, and archive technical documents in hard-copy and electronic formats as appropriate.
Collaborate with the research team to facilitate protocol operations.
Identify problems and issues, take corrective action, and/or escalate appropriately.
Track sponsor and IRB approvals and renewals.
Report on the status of clinical trials.
Generate and review regulatory data reports using appropriate systems.
Ensure assigned tasks comply with federal regulations and ICH/GCP.
Meet quality standards for documentation within project-plan timelines and company expectations.
Assist with training programs as requested.
Perform other duties as requested or assigned.