Summary
Overview
Work History
Education
Timeline
Generic

Kerry-Ann Suckra

Lauderhill

Summary

Currently working as a Regional Site Activation
Manager for North America responsible for multiple high-profile studies with 50+ sites in a Dedicated Sponsor Delivery Unit. Main responsibilities include but are not limited to driving site activation in North American sites, managing start-up activities from site IRB, IRB submissions, CTA/Budget negotiations, Essential Document Pack preparation to site activation. Successfully completed activation tasks for several studies. Ability to direct and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs.

Tremendous experience in a variety of research procedures as a community network coordinator, research associate, data management and collection, and regulatory affairs as well as in the area of phlebotomy as an instructor and clinical coordinator. Computer skills include MS Word platform, including Excel, PowerPoint, Publisher, SharePoint, SPSS database, OnCore and all major internet search engines.

Overview

22
22
years of professional experience

Work History

Regulatory and Start-Up Manager

IQVIA
04.2022 - Current
  • Oversee the execution of Start Up (including pre-award/bid defense activities) and Maintenance for assigned projects in accordance with the agreed
    RSU strategy, adhering to project timelines.
    Develop, implement, and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project-related issues where required.
    Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
    Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as
    required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during the initial start-up and maintenance phase, as an integral member of the study management team.
    Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and
    challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan. Assess and review the regulatory landscape, and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and the wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential
    documents.Work with Quality Management to ensure appropriate quality standards for the duration of Start Up (or Maintenance, as applicable).. Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred Quintiles customers. Deliver presentations/training to clients, colleagues and professional bodies, as required.

Study Start-Up Country Specialist II

Clinipace
08.2021 - Current
  • The Study Start-Up Country Specialist (SSUCS) works in collaboration with project teams and in collaboration with the Study Start-up Manager to perform key study start-up tasks in their country, or countries, of expertise. These tasks may include study feasibility, facilitation of site contracts and budget negotiations between sites and CP, review of document translations, IRB submissions, and other study start up activities, as assigned by the Study Start-Up Manager or designee. The Study Start-Up Country Specialist is responsible for the collection of essential regulatory documents from sites and preparation or review of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws, guidelines and ethical standards within specific timelines and quality standards. May coach, mentor or on-board more junior Specialists.

Clinical Trials Coordinator, Regulatory Affairs

University of Arizona, Tucson, AZ
Tucson
10.2017 - 08.2021
  • The Clinical Trials Coordinator maintained electronic file storage; inventory and manage submissions via intake web-based portal. Acted as the institutional administrator for Clinicaltrials.gov. This role also supports faculty, trainees, staff and others in preparing, finalizing, and submitting timely and complete applications and authorizations including new projects, modifications, IRB submissions to local and central IRBs, partial HIPAA waivers, continuing reviews/renewals and protocol deviations reporting and submission. Other tasks include completing 1572 and FDFs at study start-up and update as necessary throughout the study.

Regulatory Specialist/IRB Coordinator

University of Arizona, Tucson, AZ
Tucson
05.2016 - 10.2017
  • The Regulatory Coordinator prepare and/or coordinate IRB submissions and approvals of new phase I-III protocols for industry, investigator initiated, and national cooperative group studies in assigned disease area. The regulatory coordinator also serves as a liaison between the assigned disease team, industry/cooperative group representatives, and the IRB for activation and maintenance of specific studies to ensure consistency of approach as well as developing strategies to ensure increased study awareness, subject enrollment, protocol compliance including maintenance of protocol information tools for the assigned disease team. Other tasks of this role include participating in routine and end of study monitoring and auditing process for assigned studies and updating the clinical trial management system (CTMS)- OnCire, relating to study status and actions.

Patient Care Associate (PCA)

Mercy Hospital, Medical Surgery Unit, St. Louis, MO
St. Louis
06.2014 - 10.2014
  • The PCA is responsible for assisting patients with activities of daily living, obtain and record vital signs into the electronic medical record, performing finger stick procedure for glucose monitoring as requested by the nurse and performs bladder scans as necessary. Other tasks include ensuring that the patients plan of care are followed as directed by the physician and ensuring that patients safety precautions and procedures are followed.

Research Patient Coordinator- Data Manager

Siteman Cancer Center, Washington University, St. Louis, MO
St. Louis
10.2011 - 02.2012
  • The Data Manager is responsible for compiling patient’s data from multiple sources (Allscripts electronic medical record, Mosaic, Touchworks Clinical Desktop) and submits for review and performs data management for research studies, including the completion of required case report forms as well as using sponsors database (Sanofi Aventis, NYU, NCI, Cancer Center Trials Support Unit). Other tasks include responding to data queries and requests from the study sponsor, grading patient laboratory results using the common toxicity criteria, submits source documents such as pathology reports and CT scans to sponsors upon request and conduct follow-up for off-study patients.

Community Network Program Coordinator

Howard University, Washington, DC
Washington
08.2010 - 06.2011
  • Maintain day to day project management, coordinate community outreach events, recruit community members to participate in practice-based research studies, assists the lead project director with meeting planning, and preparing reports as required by the project and assists in the election process for Community Advisory Board Members.

Research Associate

Howard University, Washington, DC
Washington
08.2007 - 06.2011
  • Responsibilities include performing blood draws on participants in the Men Take Ten Prostate Cancer Screening Program, assisting principal investigators in conducting a variety of research procedures, compile data and assist in preliminary analyses and write summary reports. Other tasks include assisting in editing abstracts and papers submitted for publications, assisting in preparing progress reports, presentations, and meetings as required by the project, produces quarterly newsletter for DC PrimCare Practice Based Research Network (PBRN) as well as the Department of Community and Family Medicine, ensuring adequate recruitment of subjects and participation by DC PrimCare members practice as well as facilitating active learning group for the Medicine and Society course.

Phlebotomy Instructor/Clinical Coordinator

Howard University, Washington, DC
Washington
05.2003 - 05.2007
  • Responsibilities include preparing lecture materials for class sessions, constructing quizzes and examinations, preparing laboratory for practical sessions which include setting up phlebotomy trays and materials for lab sessions, conduct student orientation prior to clinical rotation at Howard University Hospital.

Education

B.S. - Health Education

Howard University
Washington, DC
05.2010

M.S. - Community Health

Howard University
Washington, DC
05.2007

Timeline

Regulatory and Start-Up Manager

IQVIA
04.2022 - Current

Study Start-Up Country Specialist II

Clinipace
08.2021 - Current

Clinical Trials Coordinator, Regulatory Affairs

University of Arizona, Tucson, AZ
10.2017 - 08.2021

Regulatory Specialist/IRB Coordinator

University of Arizona, Tucson, AZ
05.2016 - 10.2017

Patient Care Associate (PCA)

Mercy Hospital, Medical Surgery Unit, St. Louis, MO
06.2014 - 10.2014

Research Patient Coordinator- Data Manager

Siteman Cancer Center, Washington University, St. Louis, MO
10.2011 - 02.2012

Community Network Program Coordinator

Howard University, Washington, DC
08.2010 - 06.2011

Research Associate

Howard University, Washington, DC
08.2007 - 06.2011

Phlebotomy Instructor/Clinical Coordinator

Howard University, Washington, DC
05.2003 - 05.2007

B.S. - Health Education

Howard University

M.S. - Community Health

Howard University

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Kerry-Ann Suckra