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.
ยท 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:
Experience:
- Clinical Research Regulatory: 1 year (Required)
Work Location: One location