Resume

Sign in

Clinical Research Manager

Location:
Humble, Texas, 77346, United States
Posted:
October 06, 2016

Contact this candidate
Sponsored by:
TalentDesk
Post Jobs to
Multiple Job Boards &
Get more Candidates
Try it Free!
Start your 30-day
Free Trial

*

M I K K I O ’ N E A L, M B A, C C R P, C C R C, C H R C

***** ****** ***** ***** • HUMBLE, TX 77346

MOBILE: 713-***-**** • E-MAIL: mikkioneal@out look.com PROFESSIONAL PROFILE

Certified in Healthcare Research Compliance (CHRC).

16 years of clinical research experience.

Nine years’ managerial experience within a health care setting.

Significant experience in compliance, policy, and education development and implementation.

Active participant in the design, build, validation, and optimization of an enterprise lifecycle implementation. PROFESSIONAL EXPERIENCE

November 2011 – Manager, Institutional Compliance, Clinical Research Billing Present The University of Texas MD Anderson Cancer Center (MD Anderson) Houston, TX

KEY ACCOMPLISHMENTS

Established and implemented an institutional-wide clinical trial billing compliance education program. The program was successfully implemented in 2012.

Led, assisted, and modified several policies and procedures related to clinical trial billing compliance.

Established and formalized a clinical trial billing compliance program within the Institutional Compliance Office

(ICO).

Established and implemented formalized clinical research billing audit program. The program was successfully implemented in 2012.

Proposed and designed an end to end clinical research billing compliance solution (“Platform”) to manage all aspects of investigations and audits, while providing real-time corrective action requirements, compliance metrics, and ad hoc compliance reports, engaged Huron and Velos for the project. COMPLIANCE DUTIES AND ENTERPRISE LIFECYCLE IMPLEMENTATION ACTIVITIES

Is responsible for management of complex clinical research-related billing & reimbursement compliance investigations related to research billing in conjunction with the senior legal officer.

Oversees the productivity and quality of clinical research billing and reimbursement compliance audits.

Conducts focused investigations into sensitive areas of suspected clinical research billing and reimbursement non- compliance.

Conducts annual institution risk assessments related to research billing. Manages the implementation and progress of the monitoring plans as it relates to clinical research billing risk.

Identifies ongoing clinical research billing & reimbursement compliance deficiencies and risk areas to the Institution. Recommends changes to operational systems/practices to ensure compliance.

Creates, modifies, and contributes to process development and change, policies, and procedures.

Participated as a subject matter expert (SME) for clinical research compliance and clinical research billing for Research Lifecycle Re-Design Project 2012 – 2014. Engaged Huron in a three-part business process re-engineering project prior to software build of the research software solution. The three phases of the project included Research Protocol Lifecycle, Clinical Research Billing Lifecycle and Research process integration.

Contributed as an SME the Research Lifecycle Re-Design Project 2012 – 2014.

Played a key role in the design, build, validation, and implementation of the clinical research and clinical research billing component within the Epic OneConnect Electronic Health Record (EHR).

Active participant in the Epic OneConnect optimization phase.

Identified and actively assisting with the management and oversight of clinical research and clinical research billing risk related to the Epic OneConnect implementation. 2

April 2011 – Compliance Analyst, Clinical Research Billing, Institutional Compliance November 2011 MD Anderson, Houston, TX

July 2010-April 2011 Manager of Clinical Research

Department of Advanced Liver Therapies

St. Luke’s Episcopal Hospital, Houston, TX

KEY ACCOMPLISHMENTS

Developed a mandatory orientation and education program for new personnel, including physicians, clinical research, and operations staff, regarding applicable regulations, departmental, and institutional expectations.

Oversaw implementation of a new clinical trial management system (CTMS), identified deficiencies and made recommendations to the vendor, which led to critical changes in the system.

Implemented and assisted with the revision of policies and procedures to ensure compliance with applicable federal and state laws as well as institutional policies and procedures. GENERAL DUTIES

Created and negotiated clinical research budgets; supported the negotiation of contract terms.

Managed the development of departmental policies, processes, and procedures to ensure compliance with applicable federal and state laws as well as institutional policies and procedures.

Guided Investigators regarding research-related activities including compliance, research billing, conflicts of interest, protocol management, staffing, etc.

Directed activities during the evaluation, design, and implementation phases of clinical trials to ensure grant and contract objectives were met and clinical goals were supported.

Managed and provided oversight of clinical research, laboratory, and operations personnel. 2007 – 2010 Regulatory Compliance Manager

Methodist DeBakey Heart and Vascular Center (MDHVC) The Methodist Hospital Research Institute (TMHRI), Houston, TX KEY ACCOMPLISHMENTS

In collaboration with the Director, transitioned multiple, independent research units within cardiology, cardiovascular/ cardiothoracic surgery, and cardiovascular anesthesiology into a unified, self-sustaining research center.

Developed and maintained a robust departmental orientation and training program for both new and existing personnel regarding the responsible conduct of research as well as applicable federal/state requirements, good clinical practice (GCP), and scope of practice.

Developed, implemented, and maintained an internal Standard Operating Procedures and Guidelines Manual to ensure program compliance with applicable federal and state laws as well as institutional policies and procedures.

Implemented programs to audit and monitor research conduct for compliance with approved research protocols and regulations; conducted internal monitoring and audits for research studies; developed corrective action plans for studies found to be non-compliant or deficient.

Participated in the institutional CTMS rollout initiative and oversaw the implementation within the MDHVC.

In addition to the management and oversight of all regulatory compliance personnel, assisted the Director with day-to-day operations of the MDHVC research center including the indirect management of 25+ clinical research staff.

2006 – 2007 Senior Clinical Research Coordinator

Methodist DeBakey Heart and Vascular Center (MDHVC) The Methodist Hospital Research Institute (TMHRI), Houston, TX 3

2005 – 2006 Senior Clinical Research Coordinator

Retina and Vitreous of Texas, Houston, TX

2001- 2005 Clinical Research Coordinator

Department of Ophthalmology

Duke University Medical Center, Durham, NC

1998 – 2001 Clinical Research Coordinator and Certified Ophthalmic Assistant Department of Ophthalmology

The University of Texas Medical Branch, Galveston, TX EDUCATION

May 2011 Colorado Technical University

Master of Business Administration

May 2009 Colorado Technical University

Bachelor of Science, Business Administration

CERTIFICATIONS, AFFILIATIONS AND COMMITTEES

2015 Annual Conference Education Planning Committee member Society of Clinical Research Associates (SoCRA)

Greater Houston/Galveston Chapter

2014 – Current Epic Integrated Research Team (IRT) Governance Committee member The University of Texas MD Anderson Cancer Center

2013 – Current Multiple Epic Advisory Committees and Work Groups (Clinical and clinical research billing operational workflows and compliance)

The University of Texas MD Anderson Cancer Center

2011 – Current Clinical Research Billing Oversight Committee member The University of Texas MD Anderson Cancer Center

2010 – Current Certified in Healthcare Research Compliance (CHRC) Health Care Compliance Association (HCCA) member

2010 – 2012 Global Membership Committee Member

Association of Clinical Research Professionals (ACRP) 2008-2010 Regulatory Affairs Professionals Society (RAPS) Member 2007 – Current Certified Clinical Research Professional (CCRP) # 26133 Society of Clinical Research Associates (SoCRA) member 2007 – Current Certified Clinical Research Coordinator (CCRC) # FDA-C-0907- 876 Association of Clinical Research Professionals (ACRP) member 4

PRESENTATIONS

Monthly Clinical Research Billing Compliance

Institution-Wide Clinical Research Billing Compliance Mandatory Training The University of Texas MD Anderson Cancer Center

Houston, TX

November 2015 EHR Compliance Risks and a Proactive Control Approach Health Care Compliance Association (HCCA) Regional Conference Nashville, TN

October 2012 Financial Management of Clinical Trials Pre-Conference Workshop Considerations for Clinical Trial Billing – O’Neal International Association of Clinical Research Nurses Annual (IACRN) Conference Houston, TX May 2012 Research Billing: What’s that and why should I care? Baylor College of Medicine

Houston, TX

May 2012 Demystifying the Research Compliance Component – As presented at the ACRP Global Conference

Association of Clinical Research Nurses (ACRN)

Houston, TX

April 2012 Demystifying the Research Compliance Component: Learn to think like a compliance professional.

Association of Clinical Research Professionals (ACRP) Global Conference Houston, TX

January 2011 A Comprehensive Review of the Informed Consent Process St. Luke’s Episcopal Hospital; Houston, TX

November 2010 Source Documentation 101: Taking it back to the basics The Texas Heart Institute

Houston, TX

October 2007 The Informed Consent Process

Methodist DeBakey Heart and Vascular Center

Houston, TX

June 2003 Vision Rehabilitation after Macular Translocation Nov and April 2002 Full Macular Translocation Course and Wet Lab Durham, NC



Contact this candidate