Top 20 Clinical research coordinator Jobs in Lakeland Fl

Clinical Research Regulatory Coordinator (Brandon, Florida)
Cardiovascular Associates of America —Brandon, FL
- Full-time
- Remote
- Mid-level
- Continuous improvement
- Associate's degree
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Clinical Research Coordinator II - Oncology
Helios Clinical Research —Lakeland, FL
- Full-time
- Vital signs
- Mid-level
- Bachelor's degree
Quick Apply
Clinical Research Assistant
Care Access —Brandon, FL
- $19 - $33 an hour
- Spanish
- Vital signs
- Computer literacy
- Health savings account
- Paid holidays
Clinical Care Coordinator
FLORIDA DERMATOLOGY AND SKIN CANCER CENTERS —Winter Haven, FL
- Full-time
- Writing skills
- Medical office experience
- Basic math
2d
Charge RN Clinical Coordinator Emergency Room
HCA Florida Brandon Hospital —Brandon, FL
- Full-time
- Mid-level
- Critical & Intensive Care
- Pediatrics
- Employee stock purchase plan
- Disability insurance
Quick Apply
13d
RN Charge Clinical Coordinator Emergency Room
HCA Florida Brandon Hospital —Brandon, FL
- Full-time
- Mid-level
- Critical & Intensive Care
- Pediatrics
- Employee stock purchase plan
- Disability insurance
Quick Apply
Clinical Research Assistant/ Medical Assistant
Alcanza Clinical Research —Lakeland, FL
- Full-time
- Spanish
- Vital signs
- HIPAA
- Health savings account
- Disability insurance
Quick Apply
CLINICAL SERVICES COORDINATOR, RN - FULL TIME
WATSON CLINIC LLP —Lakeland, FL
- Full-time
- Nursing
- Management
- RN License
Quick Apply
Clinical Manager of Research
Cardiovascular Associates of America —Brandon, FL
- Full-time
- Nursing
- 5 years
- Supervising experience
Quick Apply
Clinical Program Coordinator/Phone Call Supervisor
Central Florida Sleep Diagnostic & Treatment Center —Lakeland, FL
- $15 - $18 an hour
- Full-time
- Mid-level
- In-person
- 401(k)
- Paid time off
Quick Apply
14d
Clinical Support Coordinator Registered Nurse ER
HCA Florida Brandon Hospital —Brandon, FL
- Full-time
- Mid-level
- Critical & Intensive Care
- Leadership
- Employee stock purchase plan
- Disability insurance
Quick Apply
22h
RN Clinical Coordinator PCU Cardiovascular
AdventHealth Zephyrhills —Zephyrhills, FL
- $32.76 - $57.47 an hour
- Full-time
- Background check
- CPR Certification
- Nursing
- Paid parental leave
- Disability insurance
Operating Room Clinical Nurse Coordinator
HCA Florida Brandon Hospital —Brandon, FL
- Overnight shift
- Surgery
- Mid-level
- Critical & Intensive Care
- Employee stock purchase plan
- Disability insurance
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Clinical Coordinator/BCBA, BCOTB Riverview
BCOTB —Riverview, FL
- $80,000 - $104,100 a year
- Full-time
- Hybrid work
- CPR Certification
- HIPAA
- Clinic
- Continuing education credits
- Mileage reimbursement
Quick Apply
8d
Clinical Laboratory Scientist Coordinator
BayCare —Bartow, FL
- Weekends as needed
- Hospital
- Bachelor's degree
- Home Health
- Health insurance
- Dental insurance
Clinical Donation Coordinator I - PeeDee Region
WE ARE SHARING HOPE SC —United States
- On call
- Mid-level
- Operating room
- 2 years

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Clinical Research Regulatory Coordinator (Brandon, Florida)

Cardiovascular Associates of America -
Brandon, FL

Quick Apply

Job Details

Full-time

Qualifications

Regulatory submission editing and review
Associate's degree
Ethical review application preparation

Full Job Description

Clinical Research Regulatory Coordinator (Brandon, Florida - Hybrid)

Position Summary

The Clinical Research Regulatory Coordinator (Remote) provides centralized regulatory support for the CVRS clinical research network. Reporting to the Regulatory and Operations Manager, this position supports regulatory start-up, site activation, IRB management, regulatory maintenance, and quality review activities across multiple clinical research sites.

The Clinical Research Regulatory Coordinator is responsible for preparing and maintaining regulatory documentation, coordinating IRB submissions and amendments, managing electronic regulatory files within REALTIME, supporting study activation activities, and conducting regulatory quality reviews. This position serves as a regulatory resource for research sites and helps ensure compliance with sponsor requirements, IRB requirements, Good Clinical Practice (GCP), FDA regulations, and CVRS Standard Operating Procedures.

The ideal candidate is highly organized, detail-oriented, experienced in clinical research regulations, comfortable working independently in a remote environment, and proficient in electronic regulatory systems.

Essential Responsibilities

Study Start-Up and Site Activation

Prepare and assemble study start-up regulatory packages.
Coordinate collection of essential documents required for study activation.
Prepare sponsor-required regulatory submissions.
Support feasibility, site qualification, site initiation, and activation activities.
Coordinate sponsor and CRO requests during study start-up.
Track study activation milestones and regulatory deliverables.
Maintain study start-up trackers and timelines.

Institutional Review Board (IRB) Management

Prepare and submit initial IRB applications.
Prepare and submit IRB amendments, modifications, and protocol revisions.
Prepare and submit continuing reviews, annual renewals, and study status reports.
Coordinate submission of reportable events, protocol deviations, unanticipated problems, and safety notifications as required.
Track IRB approval periods and ensure studies remain in compliance with approval requirements.
Maintain IRB correspondence, approvals, and submission records.
Communicate IRB approvals, determinations, and required actions to site staff.
Ensure approved informed consent forms and participant-facing documents are appropriately implemented.
Maintain submission trackers and regulatory timelines.
Serve as a liaison between research sites and central or local IRBs.

Regulatory Quality Review

Conduct centralized quality reviews of regulatory files across the research network.
Review regulatory binders and electronic regulatory files for completeness and compliance.
Identify missing, expired, or incomplete documentation.
Perform regulatory reviews prior to study activation.
Conduct periodic quality reviews of active studies.
Review studies prior to close-out and archival.
Support audit readiness and inspection preparedness activities.
Escalate compliance concerns and quality issues to the Regulatory and Operations Manager.

REALTIME eRegulatory Management

Maintain study regulatory files within REALTIME.
Upload, organize, and manage regulatory documentation.
Coordinate electronic signature routing and approval workflows.
Maintain document version control.
Assist sites with regulatory filing and document management activities.
Support implementation of regulatory workflows within REALTIME.
Assist with user training related to REALTIME eRegulatory functions.

Regulatory Maintenance

Maintain regulatory documentation throughout the study lifecycle.
Track expiration dates for investigator licenses, CVs, GCP training, laboratory certifications, financial disclosures, and other essential documents.
Coordinate collection and filing of updated regulatory documentation.
Maintain delegation logs, training records, study-specific regulatory files, and essential documents.
Ensure regulatory files remain inspection-ready throughout study conduct.

Sponsor and Site Support

Serve as a regulatory resource for research sites.
Respond to regulatory questions from site personnel.
Support sponsor portal document uploads and maintenance.
Assist with sponsor, CRO, and IRB communications.
Coordinate regulatory documentation requests.
Support onboarding of new research sites and study teams.

Study Close-Out and Archiving

Conduct regulatory close-out reviews.
Verify completeness of essential documents prior to archival.
Ensure all required regulatory documentation has been collected and filed.
Coordinate document retention and archiving activities.

Training, SOPs, and Process Improvement

Support implementation and maintenance of CVRS regulatory SOPs.
Participate in regulatory training initiatives.
Assist with standardization of regulatory processes across the network.
Support CAPA and quality improvement activities as assigned.
Contribute to development of regulatory tools, templates, and best practices.

Qualifications

Education

Associate's Degree required.
Bachelor's Degree in Life Sciences, Healthcare Administration, Public Health, or related field preferred.

Experience

Minimum 2 years of clinical research regulatory experience required.
Experience preparing IRB submissions, amendments, and continuing reviews required.
Experience supporting study start-up and site activation activities preferred.
Experience working in a multi-study or multi-site environment preferred.

Preferred Qualifications

Experience using REALTIME CTMS and eRegulatory modules strongly preferred.
Experience with central IRBs and local IRBs.
Experience supporting sponsor and CRO interactions.
Experience preparing studies for sponsor monitoring visits, audits, and inspections.
Experience supporting remote research operations.

Knowledge, Skills, and Abilities

Strong knowledge of ICH-GCP guidelines.
Working knowledge of FDA regulations and human subject protection requirements.
Exceptional attention to detail and document accuracy.
Strong organizational and project management skills.
Ability to manage multiple studies and competing deadlines.
Excellent written and verbal communication skills.
Ability to work independently in a remote environment.
Proficiency with Microsoft Office applications and electronic regulatory systems.

GRPUZxxPcs

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Refine Your Search

clinical research coordinator jobs in lakeland fl

Clinical Research Regulatory Coordinator (Brandon, Florida)

Clinical Research Coordinator II - Oncology

Clinical Research Assistant

Clinical Care Coordinator

Charge RN Clinical Coordinator Emergency Room

RN Charge Clinical Coordinator Emergency Room

Clinical Research Assistant/ Medical Assistant

CLINICAL SERVICES COORDINATOR, RN - FULL TIME

Clinical Manager of Research

Clinical Program Coordinator/Phone Call Supervisor

Clinical Support Coordinator Registered Nurse ER

RN Clinical Coordinator PCU Cardiovascular

Operating Room Clinical Nurse Coordinator

Clinical Coordinator/BCBA, BCOTB Riverview

Clinical Laboratory Scientist Coordinator

Clinical Donation Coordinator I - PeeDee Region

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