Curtis Griffin Jr, MBA, CPHM

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

Richmond, TX 77407

qhkbrb@r.postjobfree.com

281-***-****

Work Experience

Research Department Manager

Oncology Consultants - Houston, TX

July 2011 to Present

• Assist the outreach and patient accruing endeavors required by each project and actively participate in the recruitment of personnel in accordance to the multi-site departmental needs

• Complete performance evaluations for personnel in the Department of Research.

• Manages 1.2 million dollar departmental budget which includes accounts receivable, expenses,invoices, and payroll.

• Communicate, disseminate, and ensure the proper compliance of the practice and Department’s policy and procedures. In order to maximize the consistency in protocol management and to decrease ambiguity, the research supervisor will ensure standard operational procedures (SOP’s), develop and implement protocol / patient specific forms and ensure their proper and consistent utilization.

• Meet with Nurses and Pharmacists regularly to provide initial instruction and implement proper procedures regarding Protocols, drug dosing, administering, injections, drug storage, etc.

• Train personnel in data entry, management and analysis; toxicity assessment, reporting of significant adverse events, and to follow up with monitoring and audit activities pertinent to pharmaceutical trials, NCI sponsored, and investigator-initiated protocols.

• Evaluate research proposals according to the practice demographics and statistics, the Departmental needs, resources, and their scientific merit; Review invited protocols and supervise the adequate maintenance of submission files.

• Development of study budgets and financial planning according to protocol submission fees, study personnel, maintenance costs, data entry, monitoring, and closing expenses.

• Oversees clinical trial budget review process and negotiations.

• Guide and assist data managers in the submission process of confidentiality agreements, feasibility questionnaires, contract negotiation, submission of documents to the different Institutional Review Boards based on the characteristics of the study and its collaborations, and maintain prompt and courteous communication with all parties involved.

• Assist in the planning and execution of site initiation visits.

• Maintain on site clinical supplies and supervise the adequate upkeep of all expiration dates.

• Independently develop and administrate budgets for research projects in the Department of Research.

Research Network Operations Specialist II

US Oncology - The Woodlands, TX

June 2009 to July 2011

• Under general supervision of the Director of Clinical Trials Management, supports and assists

in managing the oversight of network practices and their associated Phase I-III research program

operations.

• Provide guidance and advice on research protocols, federal regulations and general practice policies

from a business oversight perspective.

• Analyze site performance and recommends areas to improve performance, feasibility, and profitability.

• Rely on education, guidelines, policies, and legal requirements to perform responsibilities.

• Support and adhere to and enforces the US Oncology Compliance Program, to include (but not limited

to) the Code of Ethics and Business Standards, FDA, ICH, Joint Commissions, OSHA, NIH, and IRB

policies.

• Support the research needs of US Oncology Research Sites by responding to routine questions/

inquiries regarding good clinical practices, protocols, and standard operating practices (SOP).

• Obtain assistance to resolve complex inquiries and contacting site representatives monthly to offer

support, education and/or information.

• Review and is current on research project timelines and deliverables within assigned region.

• Work with management to understand key objectives regarding site financial and performance data.

• Gather data from the practice to review and analyze practice financial, budgetary, and operational

performance and make subsequent recommendations.

• Create reports and metrics to show key performance areas within the practices. Recommends to

Research Network Operation Managers on areas to improve efficiencies and build profitability.

• Collaborate with the central office departments to develop tools, reports, and processes to support

network practices operations and efficiencies in the clinical trial management.

• Responsible for developing educational in-services, programs, and lectures. Coordinates the logistics

and materials for meetings, special projects and site training.

• Participate in the interview, hiring, and training process of potential employees. Collaborates with

Implementation Manager to ensure smooth transition of site to Network Operations Manager.

Senior Clinical Research Coordinator

Baylor College of Medicine –VA Medical Center

Houston, TX

March 2008 to May 2009

• Work independently as a research coordinator and a manager of clinical drug research program which

included coordinating and managing Phase I-IV studies; primarily psychiatric, behavioral, and health disparities.

• Responsible for organizing the documentation and files pertaining to studies, coordinate the activities of

clinical investigators and subjects on a clinical research and business level in the behavioral, psychiatric,

pulmonary, oncology, endocrinology, and health disparities areas of study.

• Oversee post-award grant fund administration and allocation.

• Balance and appropriate study budget as well as disburse and reconcile patient payment accounts.

• Follow Office of Clinical Research (OCR), Health Service Research, and Baylor College of Medicine

standard operating procedures; abided by, enforced, and maintained departmental and institutional

compliance with federal regulations, IRB, and ICH-GCP guidelines.

• Answer and respond to patient / subject calls, maintain database of patient / subject demographics,

coordinate subject recruitment activities with study team.

• Acts as liaison between Baylor College of Medicine and affiliated institutions, coordinate and schedule

research subject appointments for tests and procedures.

• Enforce and ensure sufficient physician oversight and involvement in research study programs as

recommended by federal guidelines.

• Maintain records for clinical study and regulatory documents in confidential and HIPAA compliant

manner and assists in determining patient eligibility for research protocols.

• Prepare research program budget and order supplies and equipment necessary to support recruitment

efforts and help to track and maintain budgetary issues regarding individual research projects.

• Work closely with IRB to maintain study compliance and institute amendments, revisions, and reviews.

• Assist with statistical analysis of research studies by computer via keyboard or by using calculator and

handwritten charts and notes.

• Use strong knowledge of IRB, FDA, NIH, the informed consent process, JOINT COMMISSIONS, and

CTC grading criteria in relation to federal and administrative laws and their respective organizations to

effectively analyze and solve research issues.

• Assess and implement quality control and performance improvement measures independently.

• Perform duties training staff regarding research procedures and techniques for certain studies.

• Deal directly with industry sponsors to set up, establish, and/or maintain study requirements and

parameters through contractual obligations and standard operating procedures.

• Function in a managerial and supervisory capacity in the areas of patient recruitment, screening, and

consultation, physician recruitment/retention, and procedure scheduling.

• Responsible for patient and research staff educational opportunities, training, and learning material.

Research Data Coordinator

MD Anderson cancer Center - Houston, TX

October 2006 to February 2008

• Participate in Phase I-IV study data management and coordination that oftentimes included nationwide

and/or global (Europe, Japan, and Australia) trials..

• Retrieve research study data by visually reading patient record and outside documentation and/or by

verbally interviewing patients in face-to-face encounters or by telephone.

• Enter and maintain information in computer database via keyboard and/or by writing by hand in study

booklets and/or data forms.

• Follow and adhere to coordinator guidelines to accomplish and complete daily work.

• Consult with principal investigator and other department personnel verbally, in handwritten notes or via

keyboard on computer regarding ongoing studies.

• Required ability to gather appropriate information and determine the appropriate information to report.

• Required the ability to move from assigned office to clinic and/or hospital areas.

• Maintained a level of professional expertise and credibility through attendance at both institutional and

outside continuing education programs.

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• Demonstrate excellent oral and written communication skills when contacting other institutions

and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computergenerated

reports and/or face to face contacts.

• Assist with statistical analysis of research studies by computer via keyboard or by using calculator and

handwritten charts and notes.

• Use strong knowledge of IRB, the informed consent process, and CTC grading criteria as well as

FDA, NIH, JOINT COMMISSIONS, and other federal laws, guidelines and regulations to help maintain

departmental compliance with all aforementioned federal laws, guidelines, and regulations.

• Help create and implement quality control, performance improvement measures, and departmental

policy and procedures in addition to aiding in training staff through educational interventions and inservices.

• Aid in data collection and presentation for purposes of research articles and journal presentation.

• Work with industry sponsors, PI's, and CRA's to implement study designs and policies in relation to

contractual agreements.

• Help to create, maintain, and enter research data into various databases, EDC's, and case report forms.

CSS Specialist II

Texas Heart Institute - Cardiovascular Surgery Research - Houston, TX

April 2003 to March 2007

• Participated in Phase I-III study management and coordination that included nationwide and/or global

(Europe, Japan, and Australia) trial participation.

• Directly supervised the research program and ensured adequate employee training (physician and

coordinator), patient recruitment, and the integrity of data management systems.

• Functioned as a liaison between industry sponsors and the clinical research program.

• Responsible for the solicitation, organization, implementation, and all follow-up of FDA / IRB compliance

and completion of research projects for the Center for Cardiac Support that entailed working closely with

PI's to implement and care for patients that received various investigational cardiac research devices.

• Workflow was self initiated, and determined by the current protocols and time limits for completion;

responsible for all aspects of preclinical studies conduct and management in accordance with GLP

standards so good working knowledge of GLP, IRB, FDA, NIH, JOINT COMMISSIONS, and ICUC

regulations was required as well as ensuring departmental compliance was maintained in all aspects

of those regulations; aspects of this included protocol development and adherence and research data

collection.

• Maintain research databases in an organized fashion and assisted project managers with clinical

research projects; duties related to this were research device implantation, data collection, device

maintenance, attending site initiation visits, and data entry.

• Maintain quality assurance for departmental databases by establishing standard procedures and

developing efficient and accurate methods for computer data entry.

• Direct and/or assist in implementing functions of all aspects of clinical research projects within the

technical scope of practice.

• Used a strong knowledge of FDA, ICH requirements for clinical research to remain abreast and aware

of regulatory requirements.

• Used good communication skills for correspondence with local and collaborative IRB's, monitors, PI's,

and sponsors.

• Used strong knowledge of IRB submission requirements and regulations, strong interpersonal skills

and the ability to work independently with self motivation to help maintain a positive and health working

relationship with other allied health and professional staff.

• Helped to create curriculum and admission criteria for LVAD implant school Center for Cardiac Studies

at Texas Heart Institute.

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• Assess and implement quality control and performance improvement measures independently for

managerial review.

• Work with industry sponsors, PI's, and CRA's to implement study designs and policies.

• Aided in reviewing and reconciling budgetary issues.

• Work in a lead supervisory position to ensure training, general knowledge base, and competencies of

all new employees were maintained at or above departmental standards.

Education

Certified Professional in Healthcare Management (CPHM)

McKesson Health Solutions

June 2011 to June 2013

Master of Business Administration in Graduate Studies

Baker College - Flint, MI

2010

Bachelor of Arts

Baker College - Flint, MI

2007

Associate of Arts in General Studies

Houston Community College - Houston, TX

2004

Skills

Phase I-IV Study Management, Post-Award Grant Administration, Budget/Finance Management,

Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Access; SPSS and SAS Statistical

Software Proficiency; Healthcare Administration; Vital Signs, ICD-9/ CPT -3 knowledge, Patient/

Subject Interviews, Data Entry and Collection, Database Creation, Database Maintenance, Query

Resolution, Electronic Data Capture (EDC) Entry, Data/Statistical Analysis, Experience with CTCAE V3

Adverse Event Grading, SAE Reporting, Diverse and Profound Knowledge of Research and Healthcare

Regulations (FDA, HIPAA, EEOC, IRB, GCP, ICH), Chest/Lung Auscultation, Patient Examination/

Assessment Training and Experience, Project Management, Healthcare Finance Reporting, Patient

Recruitment, Patient Advocacy, 40-50 WPM Typing, Building Excel Spreadsheets, Cardiac Output

collection (manual and formulistic), Surgical Scrubbing, LVAD Education, LVAD Assembly, Critical

Care Training, Patient Training/Counseling/Education, Staff Training/Counseling/Education, Exceptional

Problem Analysis with Problem Resolution, IABP Operation, Sterile Procedure, Dispute Resolution,

Protocol Development, Policy Development, Research Drug and Device Training, Quality Assurance,

Research Writing, Questionnaire Administration, Financial Dashboard Analysis, Budget Analysis/

Appropriation, GCP Compliance Tracking, Physician Oversight Compliance Tracking, Educational

Research Trainer/Organizer/Presenter

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