Clinical Research Associate
Resume:
AKWASI FOFIE
Bergenfield, NJ 07621
E-mail: *******@*****.***
Experienced Healthcare Administrator
Forward thinking leader with 9 years of medical coding experience. Exceed established goals by implementing and enforcing best practices in revenue management, HR, program management, and financial controls. Possess excellent understanding of current treatment practices and coding guidelines. Familiar with many medical specialties.
Key skills and abilities include:
Healthcare Administration
Project/Program Management
ICD-9/10, HCPCS and CPT
Provider Credentialing
Strategic Planning
Staff Development & Training
Quality Management
Risk Management
Financial Analysis & Reporting
Professional Medical Coder
State & Federal Regulations
Medical Record Auditing
QUALIFICATIONS
Oversee billing, coding and credentialing functions of healthcare provision, administration, and customer service in support of profitable and quality health care. Delegate duties and evaluate performance of staff to meet standards and maximize impact of limited budgets. Implement and enforce best practices, corporate guidelines, and cost controls.
Provide clear direction, leadership, and communication necessary to achieve outcome, financial, and operating goals
Five years experience in phase I-III clinical research trial monitoring as a Study Coordinator and a CRA
Create strategic plans that balance service delivery and revenue growth with cost reduction to maximize profitability
Excellent understanding of FDA regulations and guidelines, ICH guidelines, GCPs and ability to attain and maintain working knowledge of applicable SOPs.
Experience in dialysis, diabetes, hypertension, HIV/AID therapeutic areas and proficient in medical terminology.
Highly organized, analytical thinker with strong communication skills. Exceptional liaison with global experience.
Track record for meeting timelines and ability to perform under pressure. Ambitious, flexible team member.
EDUCATION
City University of New York, Brooklyn NY
Diploma Program
American Academy of Professional Coders
PROFESSIONAL EXPERIENCE
March 2015- Present
CAC Solutions Medical Coder, Jamaica NY
Medical Coder Representatives
Provide coding documentation improvement and auditing approach to the correct selection of E/M codes, helping ensure that providers are performing the most relevant components of the history and examination while placing ultimate emphasis on the complexity of the medical decision making for the visit.
Collaborate with physicians and internal staff in development of improved capabilities in the areas of documentation, coding and compliance issues.
Correct inaccurate data as needed, reviews and evaluates existing coding and abstracted policies, procedures and government guideline to ensure compliance with various regulation, coding policies and third party payer requirements. Adheres to clean claims act and HIPPA policy and procedures.
Analyze and reconcile claims to ensure medical necessity of services is documented, resolve coding and billing discrepancies problem regarding coding and compliance issues.
Review and analyzes information contained in the medical records to ensure accurate used of ICD-10-CM and CPT codes can be assigned for principle diagnosis, complications, procedures and surgery codes.
May 2006 – March 2015
D&S Medical Auditing and Compliance Services, Brooklyn NY
Medical Coder Auditor Specialist
Interpreted provider’s progress notes and assign the appropriate diagnostic and procedural codes for accuracy
Assigned and make sure diagnosis codes are supported by the documentation and ensure adherence with ICD-9 and ICD-10CM Guidelines for Coding and Reporting.
Assigned the diagnosis codes for each chronic or major medical condition have been captured and submitted within the permitted timeframe (HCC).
Reviewed for clinical indicators and query providers to capture the severity of illness of the patient.
Kept tract of provider’s coding pattern to reduce any insurance fraud claims, clarifying information or diagnosis by communicating with healthcare providers as well as assign and identify the information by using and coding the accurate ICD-9-CM-PCS, HCPCS and CPT-4 codes.
Coded services visit using the EMR database and assigning the appropriate diagnosis and procedural codes.
August 2004 – April 2006
Digital Infuzion, Inc. Gaithersburg, MD
Business Analyst/Subject Matter Expert (BA/SME)
Write detailed description of user needs, program functions, and steps required to develop or modify computer program.
Provide content and process knowledge in the field of clinical trials research and clinical research management.
Provide expert level advice and guidance in GCP, GMP, ICH, practical research guidelines and federal regulatory requirements.
Serve as the SME for clinical research and knowledge base to the technical software development team in the areas of clinical research, FDA regulations, IRB, Informed Consent, and other related domains.
Provide expert level advice and guidance in the field of clinical research being conducted at DHHS, NIH, CDC, FDA, VA, and Academic Medical Institutes.
Review computer system capabilities, workflow, and scheduling limitations to determine if requested program or program change is possible within existing system.
Study existing information processing systems to evaluate effectiveness and develop new systems to improve production or workflow as required.
Prepare workflow charts and diagrams to specify in detail operations to be performed by equipment, computer programs and operations to be performed by personnel in system.
Conduct studies pertaining to development of new information systems to meet current and projected needs.
Plan and prepare technical reports, memoranda, and instructional manuals as documentation of program development.
Upgrade system and corrects errors to maintain system after implementation.
Assist Computer Programmer in resolution of workflow problems related to flow charts, project specifications, or programming.
Prepare time and cost estimates for completing projects.
Direct and coordinates work of others to develop, test, install, and modify programs.
August 2000 – August 2004
Renal Research Institute New York, NY
Clinical Research Associate
Senior Clinical Research Coordinator
Monitored all phases of clinical trials. Managed multiple clinical trials at multiple sites.
Monitored clinical study sites in accordance to ICH and FDA guidelines and regulations.
Adhered to Good Clinical Practices (ICH/GCP) with regard to all studies.
Function as liaison between physicians, subjects, clinical research units, Sponsors, and Human Investigation committee (Institutional Review Board).
Prepared and presented new clinical research studies, protocols and consent forms to the Institutional Review Board. Recruited and retained study subjects. Conducted pre-study visit. Conducted site initiations visits.
Conducted routine study visits and study closeout visits. Contributed to study budget negotiations.
January 2004 – August 2004
Hoffmann-La Roche Pharmaceuticals
BA16739 Phase III study (CERA)
Contributed to study budget negotiations. Prepared all regulatory documents for IRB submission.
Presented the study at the IRB meeting. Conducted patient’s selection. Affirmed inclusion and exclusion criteria.
Obtained informed consent. Conducted study assessments. Study subjects randomization. Instructed study clinical staff on drug administration.
Recorded and reported Serious Adverse Event (SAE’s) to sponsor and IRB. Dispensed Study drugs. Conducted drug accountability. Maintained source documents. Completed Case Report Forms (CRF).
Reviewed and resolved CRF discrepancies and sponsor IRB correspondence.
Prepared study test tubes for blood collection. Centrifuged and aliquot subjects blood samples.
Recorded subject’s vitals. Reviewed subjects’ laboratory reports. Reviewed subjects’ hospitalization records.
November 2002 – July 2004
Mitsubishi Pharma, North America
MCI – 196 Phosphate Binder Phase II Study
Assisted with recruitment of investigators. Contributed to study budget negotiations.
Prepared all the regulatory documents for IRB submission. Presented the study at the IRB meeting.
Conducted pre-study visits and site initiation visits. Ensured that study staff received the tools and instructions to safely recruit study subjects
Reviewed Case Report Forms (CRFs) and source documentation to ensure that data submitted on the CRFs are unimpaired. Instructed study staff on study subjects randomization. Instructed study staff on drug administration.
Recorded and reported Serious Adverse Events to sponsor and Institutional Review Board. Reviewed subjects’ laboratory reports and prepared study reports accurately and in timely manner. Conducted study closeout.
August 2000 – November 2002
Amgen Pharmaceutical
Anemia Management Demonstration Project (AMDP)
Underwent anemia management training. Recruited and retained study subjects.
Reviewed patient hospitalization records. Conducted patient queries using medical database.
Maintained source documents. Completed subjects case report forms (CRF).
Conducted subject quality of life survey. Conducted study closeout.
Additional Credentials
Technical Skills: Microsoft Office, Word, Excel, Access Project, Power Point and Outlook
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