Healthcare/Medical/Research Manager
Resume:
Curtis Griffin Jr, MBA, CPHM
Richmond, TX 77407
******.*********@***.***
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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