Wubet S. Redda, CCRA

*** ******* ******

Coppell, TX 75019

Cell: 469-***-****

adztwt@r.postjobfree.com

Passionate and results-driven Clinical Research Leader with over 15 years of research experience in managing complex clinical research trials from Phase I to Phase IV. Strong interpersonal and leadership skills to effectively communicate and build relationships with a wide range of people at all organizational levels.

Professional Experience:

Clinical Lead/Clinical Program and Site Relations Manager Anova Enterprises, Inc. 2/2021 to 2/2023

As a Clinical Lead, managed clinical research trials, product development and site development programs in a fast-paced corporate environment. While working closely with the executive team to manage operational aspects of business development and product improvements, served as a primary contact for sponsors/CROs, Research sites, Community practices and Vendors to ensure timely execution of program activities.

• Worked closely with Anova’s Senior Leadership Team to manage current programs, support business development, follow up on leads and manage campaigns to grow the business.

• Collaborated with internal and external clinical development teams to establish scope, schedule, and ensure alignment and smooth execution of the projects plans.

• Managed clinical projects for various sponsors/clients and oversee the planning and execution of clinical trials including protocol development, designing study related documents, study patient recruitment materials, data collection forms, and drafting data monitoring plan.

• Monitored trial progress and ensured that the studies are conducted in compliance with study protocols and guidelines, all applicable regulations, and SOPs.

• Established and fostered relationship with external research sites, community-based physician networks and organizations to provide access to clinical studies through AnovaOS platform and serve as a primary point of contact for study placement/activation and support physicians and sites as they engage with the AnovaOS technology platform.

• Monitored the quality of interactions and services provided by external Just in Time (JIT) for activation sites to ensure project timelines, milestones, and deliverables are met.

• Assisted with the development and maintenance of Anova’s Standard Operation Procedures (SOPs), tools, study-related documents and other guidance and training documents to ensure successful management of all aspects of clinical trials.

• Prepared regular reports and updates senior management, and clients, highlighting the status of site relationships, ongoing projects, and key metrics. Lead Site Manager/ Lead Clinical Research Associate IQVIA/ Previously Quintiles IMS 12/2015 to 2/2021

As a Lead CRA, managed the progress of clinical studies by closely collaborating with the Sponsor Clinical team and served as a primary contact for CRAs for any questions related to assigned protocol, Study Process, System Process. Conducted quality review visits/ Accompanied Site Visits (ASVs) and provided ongoing coaching and feedback to junior CRAs.

• As a Lead CRA, assisted the Clinical Project team with study management, design of study tools, documents and processes and served as a primary contact for CRAs for any questions related to assigned protocol, Study Process, System Process, and conduct refresher trainings.

• Conducted Accompanied Site Visits (ASVs) on behalf of Direct Line Mangers and provided ongoing coaching and feedback to help with development of junior CRAs.

• Mentored new clinical staff and as a Subject Mater Expert (SME) provided training and review different Roche/Quintiles systems to help CRAs during their onboarding phase. Wubet S. Redda, CCRA

134 Maywood Circle

Coppell, TX 75019

Cell: 469-***-****

adztwt@r.postjobfree.com

• Managed the progress of clinical studies at clinical investigator sites and therapeutic areas by building and managing relationships with site staff and investigators.

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

• Evaluated 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 Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.

• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Regional Clinical Research Associate (RCRA) - Oncology Theorem Clinical Research- CRO 5/2014 to 12/2015

Managed the progress of Oncology clinical studies at investigator sites and conducted monitoring visits and performed comprehensive site management activities.

• Identified potential investigator sites and conducted Pre-study Site visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.

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

• Provided feedback and training to site personnel as needed and supported sites with evaluation and recruitment process.

• Adhered to study timelines and budget and produces timely and comprehensive visit status reports and telephone reports.

• Mentored less experienced CRAs.

Clinical Research Associate / Lead CRA

St. Jude Medical- Neuromodulation Division, Plano TX 11/2012 to 5/2014 Assisted Project Manager with study-start up and approval and managed the progress of clinical studies from pre-study activities including monitoring and site management for a variety of protocols, sites, and therapeutic areas.

• Served as a Lead CRA on an IDE study and assisted Project Manager with study start-up activities including preparing documents (i.e., protocol, ICF, CRFs, Operation manuals, study aids) for FDA submission and Study Submission to Central/local IRBs.

• Managed and coordinated efforts of cross-functional project teams including product development, Budget& Contract, Data management, Biostats to support milestone achievement and to manage study issues and ensure compliance with standard processes, policies, and procedures.

• Assisted Project Manager with preparation and review of study materials at Investigators Meeting. Provided Protocol training and other study specific training to other team members and site staff.

• Collaborated with Data Management team to achieve deliverables including CRF/e-CRF

(case report form) review, database design and set-up, validation and User Acceptability testing and database deliverables to internal and external customers.

• Developed study management plans, together with team assignments and accountabilities and oversight of database maintenance.

• Conducted site monitoring visits (initiation, periodic, closeout) to ensure site’s compliance to study Protocol, FDA regulations, ICH-GCP guidelines and SOPs.

• Provided support to sites with evaluation and recruitment process.

• Assisted project managers with AE adjudication and reconciliation of AEs/SAEs Wubet S. Redda, CCRA

134 Maywood Circle

Coppell, TX 75019

Cell: 469-***-****

adztwt@r.postjobfree.com

• Maintained Investigational device supply tracking and device accountability for studies. Clinical Research Associate

St. Jude Medical- Neuromodulation Division, Plano, TX 8/2010 to 10/2012 Conducted site monitoring of clinical studies, (Site initiation, interim monitoring and Close out visits) and managed the progress of sites by tracking regulatory submissions and approvals, recruitment, and enrollment.

• Conducted site monitoring visits to ensure site’s compliance to study Protocol, FDA regulations, ICH-GCP guidelines and SOPs.

• Served as a primary point of contact for assigned study sites.

• Ensured the completion and collection of Adverse Events (AEs) and Serious Adverse Events (SAEs) and regulatory documents.

• Maintained Investigational device supply tracking and device accountability. Oncology Project Coordinator/ Associate Manager

Mary Crowley Cancer Research Centers, Dallas, TX 1/2009 to 8/2010 Same duties as Regulatory Affairs Specialist role with the following added responsibilities:

• Worked on 5-7 Oncology studies, Phase I–III studies sponsored by different pharmaceutical companies.

• Developed study specific documents and process tools to assist clinic staff with data collection and training.

• Collaborated with Project managers and conducting exit Interviews after each monitoring visits to address any issues and concerns discovered by CRAs during these visits.

• Coordinated with satellite sites to resolve database queries.

• Ensured proper record retention of study documents (regulatory, pharmacy, CRFs, and study start up / education tools)

Oncology Regulatory Affairs Specialist

Mary Crowley Cancer Research Centers, Dallas, TX 03/2008 to 01/2009 Provided regulatory and safety support for network of sites participating in 5-7 Oncology Phase I-III clinical studies for different cancer types including Ovarian, Colorectal, Pancreatic, Head and Neck and Solid tumor.

• Maintained regulatory documents from study start up through close out for all sites participating in Oncology studies sponsored by different pharmaceutical companies.

• Ensured timely distribution of information from sponsors including ongoing Oncology trial communication and Amendments and updated study documents.

• Prepared and completed submissions including consent forms, protocol summaries, and website description of studies and ongoing study updates to IRBs, IBCs, and FDA.

• Reported, monitored, and maintained files for all safety information including SAE reports, Investigational Drug Brochures, and IND Safety reports,

• Represented network of sites during sponsor monitoring visits, quality assurance audits, and other audits

Oncology Research Data Coordinator II

Mary Crowley Cancer Research Centers, Dallas, TX 11/2006 to 3/2008 Performed data entry for network of sites across 5-7 Oncology studies sponsored by different companies and for cancer types such as Melanoma, Breast, Lung, Prostate, Colorectal etc. Wubet S. Redda, CCRA

134 Maywood Circle

Coppell, TX 75019

Cell: 469-***-****

adztwt@r.postjobfree.com

• Maintained Shadow Charts for study patients including records of previous therapies, any hospitalization, labs, pharmacy, and radiation treatments.

• Ensured accurate completion of RECIST forms and receipt of copies of the corresponding images and notes and completed appropriate corresponding CRFs.

• Extracted data from patient’s medical record and completed study specific CRFs and entered data in EDC for Oncology trials in various Phase I–III

• Coordinated and facilitated monitoring visits with CRAs from sponsor companies and resolved any queries generated during monitoring visits Clinical Research Technician

RCTS, Inc. Irving, TX 12/2005 to 10/2006

Evaluated participants and obtained informed consents, enrolled participants in research studies and collected data per study protocol and SOPs.

• Conducted Patch studies and Safety-In-Use studies in areas of Dermatology, Ophthalmology, Gynecology and Pediatrics

• Managed study start-up activities including development of Informed Consent Forms, Case Report Forms, and study related patient materials.

• Screened study participants and administered informed consents and Assents.

• Prepared samples and collected data per study protocol.

• Maintained patient tracking records and data tables for assigned studies. Sabbatical Leave

Personal Development and Project Management March 2023 to September 2023

• Managed a home renovation project from start to finish including managing the finances, setting timelines, negotiating with contractors and suppliers, coordinating tasks, and overseeing the various aspects of the project until completion.

• Engaged in self-directed learning, focusing on problem solving, time management, communication skills, and clinical research.

• Traveled extensively, exploring new places, learning history, experiencing diverse cultures, and refining communication skills.

• Volunteering/ Community outreach: Organize workshops and webinars to educate people and raise awareness about various aspects of personal finance and money management. Education

University of Texas at Arlington Arlington, TX

Bachelor of Science in Biology May 2005

Certification

• CCRA – Association of Certified Research Professional (September 2012)

• Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites.

Therapeutic Areas

• Oncology- Breast, Colorectal, Lung, Melanoma, Prostate and Head and Neck

• Neurology and Musculoskeletal – Chronic Migraine, Chronic back and leg pain

• Rheumatology, Dermatology, Ophthalmology, Gynecology, and Pediatrics

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