Clinical Research Manager

CONFIDENTIAL

Stacie Ifezue, BBM

**********@*****.***

Key Career Statistics

Years in Industry 14

Therapeutic Area(s) Oncology (AML, Colorectal, Breast, and Lung, Multiple Myeloma); Urology

(Urinary Incontinence); Endocrinology (Diabetes); Cardiovascular (Hypertension, Peripheral Artery Disease, Myocardial Infarction Disease, and hyperlipidemia); Musculoskeletal (Osteoarthritis, and Rheumatoid arthritis), Women’s Health / Sexual Health (Endometriosis, Uterine Fibroid and Oral contraception); CNS

(Sexual Dysfunction - Female, Alzheimer’s Disease, and Anxiety); Infectious Diseases & Vaccines (Influenza vaccine); Depression (Postpartum and Dysthymia); Gastroenterology (Irritable Bowel Syndrome)

Late Stage Phases - Rosacea; Anaphylactic Reactions/Xolair, Botox, End Stage Renal Disease, Pediatric Observational Study for Vitamin D Receptor, Prostate Cancer

Development Phase(s) Phases 1 - IV

Major Geographies North America – United States

Languages English

CURRENT POSITION: Syneos Health on Assignment with Abbvie, Clinical Division Houston, TX Sr. Clinical Research Associate 3/2017 to present

• Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas.

• Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put into place as needed to ensure compliance.

• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

• Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.

• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

• Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/COM/ Sr COM as appropriate, as defined in the study monitoring plan.

• Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.

• Implements appropriate activities to ensure the site meets the enrollment target within the agreed timeline.

• Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.

• Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.

• Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.

• Supports remote monitoring, if and as applicable. Page 2 of 4

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• Employs good financial management to conserve costs of departmental operation and control travel expenses, with guidance from Senior ACOM/COM/Sr COM as appropriate.

• Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders.

• Maintain and complete own expense reports as per local and applicable guidelines.

• Identifies, evaluates and recommends new/potential investigators/sites on an on- going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

• Participates in departmental and other functional meetings as needed, including.

• Site Management & Monitoring meetings.

• Identifies and partners with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs.

• Maintains knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities.

• Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.

• Maintains appropriate communication with relevant functional areas.

• Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. ICON Clinical Research Sugar Land, TX

Sr. Clinical Research Associate 11/ 2012 to 3/2017

• Site selection, initiation, monitoring and close-out visits in Perform accordance with contract scope of work and good clinical practice.

• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

• Administer protocol land related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

• Evaluate the quality of integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM) and/or line manager.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

• Act as a mentor for clinical staff.

• May provide assistance to the CPM/CRS with design of study tools, documents and processes. Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic Page 3 of 4

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areas.

PROFESSIONAL

EXPERIENCE:

United BioSource Corporation Kansas City, MO

Sr. Clinical Research Associate 06/2011 – 11/2012

• Consistently completes travel scheduling in accordance with project specific and UBC guidelines

• Consistently completes onsite monitoring in accordance with project specific timelines.

• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections

• Ensures follow-up of site issues and action items per UBC/sponsor timelines

• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS

• Monitors within EDC data entry, if applicable, and assists sites with DCF resolution

• Completes Regulatory Binder and Investigational Product reconciliation

• Maintains regular contact with assigned sites per study requirements

• Consistently submits expense reports within UBC timelines; consistently follows UBC Travel Guidelines

• Consistently completes SOP review and documentation within requested timelines and sponsor specific training

• Assists PM and management team by being an AIM leader

• A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently

• I = Instruct how to conduct visit, report/letter writing and manage issues and actions

• M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit

• Assists management team by mentoring other CRAs

• Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training Quintiles Transnational Austin, TX

Sr. Clinical Research Associate 11/2007 – 06/2011

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution Page 4 of 4

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• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

• Act as a mentor for new clinical staff.

Dr. Mohamed Haq Houston, Texas

Study Coordinator 08/2004 – 11/2007

• SAE reporting

• CRF completion

• Maintained Regulatory Documents

• Maintained IRB standards

• Dispensed study medication

• Resolved queries

• Coordinated patient visits

• Assisted monitors during routine visits

Neeman Medical International Cary, NC

Clinical Research Coordinator 05/2003 – 08/2004

• CRF completion

• SAE reporting

• Maintained Regulatory Documents

• Maintained IRB standards

• Dispensed study medication

• Resolved queries

• Coordinated patient visits

• Assisted monitors during routine visits

EDUCATION: LeTourneau University Houston, TX

Bachelor Degree – Business Management 2007

San Jacinto College Houston, TX

Associates –Technology 1987

Computer Knowledge:

Microsoft Word, Lotus Notes, Windows XP, Impact, eClinical, Inform, MediData/Rave, CTMS, PowerPoint, Concur and iExpense

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