Clinical Research Assistant Position Available In Miami-Dade, Florida

Clinical Research Assistant NewGen Health Group

LLC 15155 SW

97th Avenue, Miami, FL 33176

Position Summary:

We are seeking a highly organized and detail-oriented Clinical Research Assistant to support the daily operations of clinical research studies conducted at NewGen Health Research Group. This role will assist the research team in study start-up activities, ongoing study conduct, and close-out procedures, ensuring compliance with Good Clinical Practice (GCP), study protocols, and regulatory requirements.

Key Responsibilities:

Protocol Familiarization & Implementation Review and interpret study protocols to understand objectives, timelines, eligibility criteria, and required procedures. Assist in translating protocol requirements into practical site workflows. Collaborate with the research team to ensure accurate protocol implementation throughout the study lifecycle. Source Documentation & Study Preparation Create and maintain source documents based on the protocol and case report forms (CRFs). Prepare subject visit documentation and ensure completeness and accuracy of study records. Support regulatory binder set-up and ongoing maintenance. Regulatory & IRB Submissions Assist with the preparation and submission of study documents to Institutional Review Boards (IRBs), including initial submissions, amendments, continuing reviews, and reportable events. Track submission timelines and maintain communication with IRB coordinators. Maintain regulatory files in compliance with sponsor and FDA guidelines. Study Coordination Support Aid in subject recruitment, screening, and follow-up procedures as directed. Schedule subject visits and coordinate with clinical and administrative staff. Collect and enter data accurately into study databases and CRFs. Communication & Collaboration Communicate effectively with sponsors, CROs, monitors, and site staff. Participate in team meetings, site initiation visits, and monitor visits. Report issues or deviations to the study coordinator and assist in implementing corrective actions.

Qualifications:

Bachelor’s degree in a health-related field (preferred) or equivalent clinical research experience. Strong understanding of clinical research processes, GCP, and regulatory requirements. Excellent written and verbal communication skills. Highly organized with attention to detail and ability to manage multiple tasks. Proficient in Microsoft Office Suite and comfortable with electronic data capture systems.

Preferred Experience:

Prior experience working with IRB submissions and regulatory documentation. Familiarity with source documentation preparation and protocol interpretation. Experience in clinical trial site coordination or research setting is a plus.

Job Type:

Full-time Pay:

$20.00 – $22.00 per hour Expected hours: 40 per week

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Physical Setting:

Office Schedule:

Monday to Friday Weekends as needed Application Question(s): Able to create source documents, Able to interpret protocols Medical background experience

Location:

Miami, FL 33176 (Required) Ability to

Commute:

Miami, FL 33176 (Required) Ability to

Relocate:

Miami, FL 33176: Relocate before starting work (Required)

Work Location:

In person