Regulatory Clinical Research Coordinator

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

Responsibilities include but are not limited to:

• 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.
• Maintain regulatory-related internal tracking systems.
• 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.
• Ensure completion of pre-site selection processes including Confidentiality Disclosure Agreements (CDAs) and Feasibility Questionnaires (FQs).
• Communicate with study staff to ensure the maintenance and accuracy of the Delegation of Authorities log and other important 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.
• Meet with pharmaceutical/sponsor monitors.
• Work closely with the research staff to assure that all regulatory documents for research studies are current.
• Review protocol submissions for completeness and communicates with PI and Director to correct deficiencies as it relates to completeness.
• Review researchers' entries in electronic systems.
• Compilation of regulatory documents.
• Perform data entry.
• Assist in Quality Control (QC) and Quality Assurance (QA) functions.
• Understanding and implementation of current federal regulations and guidance documents as well as departmental SOPs.
• Communicate with the research community.
• Assist with tracking the progress of a clinical trial including subject recruitment, trial supplies and trial documentation.
• Assist with compiling ethics and regulatory applications for submission.
• Assist with the development and maintenance of Trial Master Files.
• Act as a liaison between the Director and other team members.
• Assist in the preparation of study documentation, forms, and the development of administrative and filing systems and processes.
• Assist in the distribution of study documents to investigators and site staff.
• Maintain up to date participating sites information (including all contact details, contracts, and reports).
• Assist with the collection, review and tracking of regulatory documents and safety data.
• Proactively identifies study administrative issues.
• Assist with the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation, and destruction.
• Provide administrative/technical support to study team.

· Attend weekly staff meetings and update research staff on the status of change in regulatory documents, submissions and amendments.

Experience required: 2 years working experience in regulatory; experience must be within the last four years.

Qualified candidates only need apply. Submit your current resume and three professional references for consideration.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you currently reside in South Florida?

Education:

• Bachelor's (Required)

Experience:

• Clinical Research Regulatory: 1 year (Required)

Work Location: One location