Faryal Dina

• Collaborate with the Clinical Research Organization (CRO) to track the various stages of startup clinical studies.
• Facilitate the startup process by stepping up and taking the lead where needed.
• Prepare and submit regulatory documents for IRB submission and IND submission to the FDA for initial applications, annual reports, amendments, and closures.
• Prepare and submit applications for institutional biosafety for studies that require IBC approval. Orient and provide ongoing training to team members.
• Provide supervision to the team, respond to their queries, resolve issues as they occur, and initiate corrective actions.
• Participate in study audits, prep studies, respond to audit queries, and ensure compliance.
• Prepare and submit annual reports for DSMB review.
• Work with subject matter experts to obtain single patient, compassionate use, and Emergency IND approvals from the drug sponsors. Prepare and submit applications for SIND approvals to the FDA.
• Maintain single patient/compassionate use INDs, with the FDA and IRB for amendments, renewals, and closures.
• Maintain and update the ClinicalTrials.gov database for studies.
• Maintain a working knowledge of clinical research concepts, policies, and regulatory procedures through internal SOPs, human safety protection regulations, and laws.
• Responsible for 60-plus protocols, including 5 active IND studies, of which 3 are multi-site studies.
• Identify and mitigate potential regulatory compliance risks, formulate solutions, make recommendations, and initiate corrective actions.
• Knowledge and experience working with a variety of local and external IRBs, biosafety committees, scientific review committees, national cooperative groups, industry sponsors, academic sponsors, and federal funding organizations.
• Work with sponsors to modify the informed consent document and protocols. Develop consents for compassionate use programs.

Multi-Site Project Management

• Responsible for the management of multi-site clinical research projects. Establish tools to track the startup and current status of sites.
• Partner with stakeholders across multiple sites to identify barriers in the project management process.
• Obtain essential documents (1572, FDF, delegation, GCP, HSP, CV, HSRP). Collect and track regulatory approvals.
• Handle various sites, and set priorities to complete ongoing tasks with competing deadlines. Comfortable with evolving priorities and dealing with ambiguity.
• Collaborate with sponsors, PIs, and clinical research staff to facilitate protocol activities and maintain study documents.
• Participate and collaborate in investigator meetings with all cross-functional team members.

• Responsible for over 100 protocols at various life stages, under various principal investigators.
• Developed and maintained a database of regulatory information for assigned products.
• Participated in meetings with external organizations such as professional associations and trade groups to discuss current trends in regulations affecting the company's products.
• Assisted in the preparation of responses to questions from global health authorities regarding regulatory matters.
• Reviewed and evaluated regulatory documents to ensure compliance with applicable regulations.
• Drafted letters of response to inquiries from government agencies concerning regulatory issues.
• Maintained records of all interactions with regulators including correspondence, minutes of meetings.
• Prepare and submit regulatory documents for IRB submission and IND submission to the FDA for initial applications, annual reports, amendments, and closures.
• Utilize knowledge of clinical research, and work in compliance with ICH GCP guidelines and internal SOPs.
• Act as a liaison between institutional review committees, regulatory agencies, and the investigators to ensure that protocols obtain applicable approvals, and that protocol amendments and renewals are submitted appropriately.
• Work with the study team to assure that all regulatory documents, such as delegation logs, financial disclosure forms, and Form FDA 1572, etc.
• Facilitate communication with the IRB and other applicable agencies related to adverse events, and UPIRSO, SUSAR, or AESI reporting.
• Assure distribution of appropriate information between investigators, regulatory agencies, and staff involved in the implementation of research projects.
• Maintain the regulatory database, electronic, and paper study files in accordance with local SOPs.
• Attend all required meetings, including feasibility, site initiation visits, close-outs, and monitor visits, and keep the study team informed of protocol-related issues.

Responsible for the overall effective operation of more than 55 active clinical research protocols in Phase I, which involve the collaboration of the clinical research services laboratories. This includes the development, design, and resolution of operational issues in collaboration with the principal investigator and the study sponsor.

• Provide leadership for effective protocol research sample collection, processing, and shipment to sponsor-designated labs across the nation and worldwide.
• Manage the new protocol start-up process. Participate in site initiation visits (SIVs), audits, and monitor visits; obtain clarification of outstanding issues related to sample collection, processing, and shipment; and capture all the information addressed in draw sheets and team presentations.
• Create collection orders in accordance with protocol requirements, and collaborate with study sponsors to ensure lab manuals are developed correctly.
• Monitor the start-up process, and ensure the technical lab personnel and supervisors are fully aware of their functions.
• Collaborate with department faculty, the study chair, or the protocol sponsor regarding protocol amendments.
• Manage industry sponsor relations and act as a liaison between sponsor representatives and the clinical research study team.
• Develop and maintain a productive working relationship with the study monitor.
• Perform quality analysis audits to monitor compliance and accuracy of data.
• Assist in quality control, and provide assistance to the daily laboratory operations.
• Provide assistance to the department in eradicating paper collection sheets and building them into the online MD Anderson’s Advanced Research Management and Data Analysis system (ARMADA).

• Worked in accordance with Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles set forth in the CFR, and ICH guidelines.
• Adhered to the Health Insurance Portability and Accountability Act (HIPAA), ensuring patient privacy is met.
• Scheduled, coordinated research start-up, and participated in the pre-site initiation visits, site initiation visits, investigator meetings, audits, and close-out visits.
• Identified and recruited clinical research subjects, and monitored enrollment goals.
• Scheduled and conducted subject visits, obtained oral and written informed consent, and processed data from the visits.
• Processed and shipped lab specimens efficiently and cost-effectively; maintained inventory for kits and equipment.
• Responded promptly to patients’ complaints, inquiries, and requests for information, and coordinated appropriate follow-up calls and/or appointments.
• Paid reimbursements and reconciled accounts associated with studies.
• Monitored drug storage and documented drug compliance.
• Handled drug dispensation, IP destruction logs, per study protocol requirements.
• Completed case report forms (CRFs) and data clarification forms per study protocol requirements.
• Maintained study regulatory documents, including logs for screening and enrollment, drug accountability, subject identification, temperatures, and site signature.
• Communicated regulatory aspects with sponsors and CROs regarding pertinent issues (e.g., Adverse, serious adverse events, deviations, exemptions, enrollment statistics, and FDA compliance.