Emily Suzanne Smith

Analyze and compare documents for consistency and accuracy: Protocol document, Data Collection Forms, Informed Consent Forms, Device User Manuals, Investigator Brochure. Query study teams when inaccuracy and inconsistency is identified in study protocol, ICF, IB, and eIRB application. Advise faculty, research staff, research administrators and medical students in regulatory compliance of conducting human subjects research. Cultivate relationships with PIs, study staff, and sponsors to ensure study protocol is followed correctly and that federal regulations and ICH-GCP is followed.

KEY ACHIEVEMENTS:

• Pre-review, create, and assign agendas for board meetings on weekly basis (over 550 full board meetings to date).
• Developed monthly educational newsletters for 80+ board members and 11 IRB personnel.
• Created detailed training materials used to successfully onboard IRB personnel during Wake Forest Baptist Health's recent merge with Atrium Health.

Identified and resolved inconsistencies in protocol, eIRB application, and consent form documents through tedious review. Communicated Board concerns to researchers clearly and provided quick turn around time on IRB submissions. Identified clear connections between FDA research regulations and IRB policies to eliminate or reduce confusion and help employees achieve regulatory compliance.

KEY ACHIEVEMENTS:

• Part of IRB team that developed and implemented innovative review process that reduced regulatory review turnaround time by 50%, equaling efficiency of commercial IRBs.
• Received CIP certification from PRIM&R in 2015.
• Created streamlined application review process that identified major concerns in electronic IRB submissions, resulting in faster, more accurate reviews.

Planned, designed, and scheduled all phases for large projects. Created all study documents: study protocol, recruitment materials, electronic data capture forms, source documents, and informed consent documents. Achieved project deadlines by coordinating with other universities to manage performance. Executed all IRB submissions for 3 NIH sponsored multi-center trials.

KEY ACHIEVEMENTS:

• Managed trials for multiple indications: yoga in menopause, acupuncture in menopause, and smoking cessation in lung cancer patients.
• Coordinated with cross-functional teams to resolve project issues and mitigate risks to research study participants.

KEY ACHIEVEMENTS:

• Developed and maintained project documentation for reliable records.
• Devised and implemented attainable schedules, timelines, and milestones for on-track projects.
• Areas of research included: Psychosis is Parkinson's disease, Cervical dystonia, stroke, carotid artery stenosis, multiple sclerosis, and ALS.

KEY ACHIEVEMENTS:

• Responsible for assisting with facilitation, management, and coordination of start-up activities/site activation.
• Obtaining and tracking documents and systems access for all site personnel: 1572, CVs, COI Disclosure Forms.
• Manage study documents, track site enrollment, dispense investigational product (IP).
• Managed international, multi-site, NIH funded trial SPS3 for Wake Forest University Health Sciences.

Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Screened patient records, databases, and physician referrals to identify prospective candidates for research studies. Collected data and followed research protocols, operations manuals, and case report form requirements. Maintained temperature control logs. Followed informed consent processes and maintained records. Coordinated studies for various disease indications: premature ejaculation, erectile dysfunction, urinary incontinence, hypertension, and hypercholesterolemia.

KEY ACHEIVEMENTS:

• Participated in site initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Performed phlebotomy, processed, and shipped lab specimens.