Diana Herrera

Summary of Position:

The Regulatory Documents Manager is the point of contact for Institutional Review Boards (IRBs) and Sponsor (Pharmaceutical) employees/ contractors in regards to regulatory documents. Leads and contributes to the development implementation and analysis of specific research projects.

Primary Duties and Responsibilities:

The Regulatory Documents Manager plays a pivotal role in the efficient progress of a clinical study. Organizes the documentation of files pertaining to the study and coordinates the activities between site, sponsor and regulatory agencies. Some duties include, but are not limited to:

* Compiling study and regulatory documents for Sponsor and IRB

* Ensure rapid study start-up of new studies with all documents being signed and submitted in a timely and efficient manner

* Reviewing FDA guidelines

* Participating in on-site Sponsor meetings

* Creating and maintaining CVs for site staff

* Maintaining study specific logs

* Maintaining all regulatory binders including proper filing of documentation

* Preparing regulatory binders for storage

* Obtain signatures from site staff and physicians on appropriate forms in a timely manner

* Complete questionnaires from regulatory agencies

* Ensure site has regulatory approval for all active studies

* Ensure site has updated IRB approval of annual study renewals

* Communicate professionally with Sponsor and IRB employees

* Obtain signatures from off-site contracted physicians via courier or in person as appropriate

* Ensure regulatory binders are organized for Sponsor and FDA inspections and audits.

* Performs Venipuncture Blood Draws and ECGs as required per study protocols.

• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Gathered, processed, and shipped lab specimens.
• Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
• Followed informed consent processes and maintained records.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
• Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
• Maintained accurate and up-to-date case report forms and source documents for traceability.
• Monitored patient safety throughout clinical trials and reported any adverse events.
• Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
• Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
• Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
• Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
• Directed site initiation visits, establishing key partnerships with local healthcare providers to facilitate successful trial implementation.
• Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
• Implemented electronic data capture system, significantly reducing paper use and increasing data retrieval efficiency.
• Streamlined patient visit schedules, reducing wait times and increasing patient satisfaction.
• Enhanced patient compliance with study protocols by creating informative and engaging participant materials.
• Coordinated with multiple departments to ensure compliance with regulatory standards, leading to successful trial audits.
• Monitored adverse events and ensured timely reporting to regulatory bodies, maintaining high safety standards.
• Facilitated communication between research team and study sponsors, ensuring clear and consistent updates on trial progress.
• Streamlined process for serious adverse event reporting, enhancing safety monitoring efforts.
• Followed safety protocols while handling hazardous materials.
• Weighed products prior to shipment to confirm accuracy.
• Operated and maintained testing equipment.
• Cultivated positive working relationships with colleagues, fostering an environment conducive to open communication and collaboration.