Clinical Research Regulatory Specialist Visionary Investigators Network Coconut Grove, FL Job Details Full-time From $65,000 a year 11 hours ago Benefits Health savings account Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Parental leave Vision insurance 401(k) matching Professional development assistance Life insurance Referral program Retirement plan Qualifications Teamwork Microsoft Excel Microsoft Outlook Clinical research Regulatory compliance Filing Microsoft Office High school diploma or GED Schedule management ICH guidelines Records management Organizational skills Good Clinical Practice (GCP) IRB compliance Cross-functional collaboration Ethical review application preparation Cross-functional communication FDA regulations Time management Research compliance quality assurance records management

Full Job Description Job Summary:

Visionary Investigators Network (VIN) is seeking an experienced and highly organized Clinical Research Regulatory Specialist to join our Coconut Grove, Florida clinical research site. This position is responsible for managing regulatory documentation and submissions throughout the lifecycle of clinical trials, ensuring studies remain compliant, current, and inspection-ready. VIN is a clinical research site network primarily focused on neurology research. The Regulatory Specialist will work closely with investigators, site staff, sponsors, CROs, and IRBs to support the regulatory execution of clinical trials from study start-up through closeout. The ideal candidate has hands-on experience with clinical research regulatory affairs and IRB submissions , exceptional attention to detail, and the ability to independently manage multiple studies and competing deadlines.

Important Location Requirement:

This is a fully in-person position at our Coconut Grove, Florida location, Monday through Friday. Remote and hybrid work are not available for this role. Candidates must currently live in South Florida and be willing and able to commute to Coconut Grove daily . Please carefully consider the commute before applying.

Key Responsibilities:

Maintain accurate, complete, and inspection-ready regulatory files for assigned clinical trials Prepare and submit regulatory documents to IRBs, sponsors, and CROs as required Manage initial study submissions, continuing reviews, protocol amendments, informed consent revisions, and study closures Prepare and/or adapt informed consent forms and ensure required elements are appropriately incorporated Track IRB submissions, approvals, expirations, and other regulatory deadlines Maintain and submit Investigator Brochures and subsequent revisions throughout the study lifecycle Coordinate regulatory documentation related to protocol amendments, safety information, and serious adverse events Track and distribute sponsor safety letters and other regulatory correspondence as required Prepare and submit interim reports, continuing reviews, and final study reports Maintain current investigator and study staff documentation, including CVs, licenses, certifications, training records, and other essential documents Communicate effectively with investigators, sponsors, CROs, monitors, IRBs, and internal study teams regarding regulatory requirements and outstanding items Support study start-up activities by collecting, preparing, reviewing, and submitting required regulatory documentation Support monitoring visits, audits, and inspections by ensuring regulatory documentation is complete and readily available Prepare regulatory study files for closeout and archiving Maintain compliance with applicable FDA regulations, ICH-GCP guidelines, IRB requirements, study protocols, and

VIN SOPs Qualifications:

At least 3-4 years of clinical research regulatory experience Hands-on experience preparing and managing IRB submissions and clinical trial regulatory documents Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical research requirements Strong understanding of essential study documents and regulatory file maintenance Exceptional attention to detail and organizational skills Strong time-management skills with the ability to manage multiple studies, priorities, and deadlines simultaneously Strong written and verbal communication skills Ability to work independently with minimal supervision while collaborating effectively with investigators and cross-functional teams Proficiency with Microsoft Office, including Word, Excel, and Outlook High school diploma or equivalent required; bachelor's degree in a healthcare, life sciences, or related field preferred Must currently reside in South Florida and be able to reliably commute to our Coconut Grove location daily

Preferred Qualifications:

Experience with neurology or CNS clinical trials Experience with electronic regulatory systems, CTMS platforms, and/or eRegulatory binders Experience supporting sponsor monitoring visits, audits, or regulatory inspections ACRP or SOCRA certification

Why Join Us:

At VIN, you'll be part of a team focused on advancing treatments for neurological conditions that have a profound impact on patients and families. Our regulatory team plays an essential role in making that research possible by keeping studies compliant, organized, and moving forward. We value empathy, accountability, resilience, teamwork, and excellence in clinical research. We offer opportunities for professional growth and development within a specialized clinical research organization, along with competitive compensation and a comprehensive benefits package.

Benefits:

401(k) 401(k) matching Dental insurance Disability insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Referral program Retirement plan Vision insurance

Schedule:

Monday to Friday Day shift 8-hour shift Full-time, 40 hours per week 100% in-person at our Coconut Grove location This position is not remote or hybrid Ability to

Commute:

Coconut Grove, FL 33133(Required)

About Us:

www.

VINTrials.com

Job Type:

Full-time Experience:

Clinical research regulatory: 3 years (Required)

Work Location:

In person, Coconut Grove, FL 33133

Job Type:

Full-time Pay:

From $65,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Referral program Retirement plan Vision insurance Application Question(s): Are you currently located in South Florida? Do you have hands-on experience preparing and submitting documents to an IRB? Please briefly describe the types of clinical research regulatory submissions you have independently managed.

Experience:

Clinical Research Regulatory:

3 years (Required) Ability to

Commute:

Coconut Grove, FL 33133 (Required)

Work Location:

In person