Job description

The Neurology Institute, LLC; Healthcare Innovations Institute, LLC in Coral Springs, FL are seeking an experienced, full time, Clinical Research Coordinator's to conduct pharmaceutical sponsored clinical trials from pre-study preparation through closeout visit in accordance with FDA regulations and GCP guidelines.

Competitive salary and benefits.

MINIMUM OF 2 YEARS EXPERIENCE IS REQUIRED

Position is full-time, in person, and not eligible for remote work.

Responsibilities include but are not limited to:

• Identify and screen patients for enrollment.
• Conduct follow up visits.
• Document all work activities.
• Coordinate and store protocol files, protocol submission documents including correspondence from sponsor and study team.
• Experience preparing source documents, reviewing and conducting Informed Consent process with subjects, EDC entry and query resolution, and completing all study specific documents within the specified timeline.
• Timely completion of work and meeting strict deadlines.
• Experience as an Infusion RN mixing and administering IP per protocol specifications is a plus.
• Ensure compliance of all general and trial specific regulatory related processes and documents with OPs, FDA, NIH, and applicable regulations for reporting of events.
• Coordinate and store protocol files including but not limited to: all protocol submission documents, correspondence from sponsor and study team.
• Communicate with study staff to ensure the maintenance and accuracy of the study forms and logs.
• Ensure that all trainings are complete for all study personnel and documentation maintained in the regulatory binder.
• Ensure all necessary forms are submitted to sponsors and the IRB in timely manner.
• Meets with pharmaceutical/sponsor monitors.
• Works closely with the research staff to assure that all regulatory documents for research studies are accurate and current.
• Attend weekly staff meetings and updates research staff on the status of change in regulatory documents, submissions and amendments.
• CPR, GCP, IATA, and HIPPA certifications.
• Phlebotomy and/or Infusion certifications are a plus.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• How many years of pharmaceutical clinical research do you have?
• Are you experienced from start up to close out?
• Describe your specific experience as a CRC

Work Location: In person

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