Adele Morrison, R.N., B.S., C.C.R.A.Sr. Clinical Research Associate

104 Patrick Drive,Jeannette, PA 15644Office: 724-744-2098Mobile: 724-787-5692

Email: adele.morrison@comcast.net

SUMMARY OF QUALIFICATIONS I am a sharply focused Senior CRA with over 10 years of experience as a CRA, as is

detailed below. I have also been a Registered Nurse for >30 years. I conduct all sites visits efficiently and in a cost-effective manner. I thoroughly

prepare for each visit to ensure that all time on site is best spent in data review, accountability, and fostering strong relationships with site staff.

I have extensive multi-therapeutic area experience monitoring phases I through IV, including oncology studies, and device studies.

I have a fully functional home office in the Pittsburgh, PA area, where I reside, – one hour from Pittsburgh International Airport, as well as a second home in southwest FL, just 20 minutes from the Ft. Myers airport. I have a small airport near to my home in PA, which flies to several Florida areas non-stop.

On a personal note, I prefer mid-west to south-east areas sites, as opposed to exclusively north-east, but am willing to go anywhere as study needs dictate.

THERAPEUTIC AREA EXPERIENCE

Phase III ELAD, (Extracorporeal Liver Assist Device), a Human Cell-Based Artificial Liver Support System study for subjects with Alcohol Induced Liver Disease

Phase III ELAD, a Human Cell-Based Artificial Liver Support System study for subjects with Severe Acute Alcoholic Hepatitis who are Lille Score Failures

Phase III ELAD, a Human Cell-Based Artificial Liver Support System study for subjects with Acute Liver Failure

Lumacaftor + Ivacaftor in Subjects Aged 12 and up With Cystic Fibrosis – Phase III Metastatic or locally advanced solid tumors, to determine safe dosing/PK – Phase I Hyperlipidemia – Phase IIb, Phase III Cardiovascular – Atrial Fibrillation – Phase III Infectious Diseases/Candidemia/Invasive Candidiasis/Sepsis – Phase IV Narcotic analgesic for subjects with opioid induced constipation – Phase II Cardiovascular Imaging – Phase III Pharmacologic stress agents – Phase III COPD (drug and device delivery systems) – Phase II Lung transplant – Retrospective Review Oncology, (tumor pain) – Phase II Stem Cell Transplantation study, - Phase II Vaccine, (co-monitoring) – Phase III

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GI – Phase III HIV – Phase IV

EDC EXPERIENCE Oracle Clinical Remote Data Capture 4.6InForm Phase Forward Medidata RaveTrial Driver

Employment History – Clinical Research:

Date of Employment:

6/2014 – Present; nearing completion of a 1 year contract

Name of Employer: XXXX – WithheldJob Title: Home based Senior Regional Clinical Research Associate IIIKey Responsibilities:

• Provide clinical monitoring services for Phase III clinical biologic/device trials• Weekly Travel on average was 75%, regionally based with occasional nationwide travel as necessary.• Train clinical site personnel on protocol-specific requirements, including the use of electronic data capture systems (EDC)• Conduct Interim visits per GCP, FDA Code of Federal Regulations and ICH guidelines• Review and verify case report form data against source documents for accuracy and validity, ensure protocol compliance and function as the main study liaison between clinical sites and clients.Conduct Pre-Study site Selection visits, Site Initiation Visits, and collect all study start up documentation.• Train site personnel; assist sites in obtaining IRB approvals, prepare requisitions for shipment of lab specimens, review regulatory documents and general site management.

Date of Employment:

10/2013 – 6/2014

Name of Employer: QuintilesJob Title: Home based Senior Regional Clinical Research Associate III

Key Responsibilities:

• Provide clinical monitoring services for multi-therapeutic phase I and III clinical trials including pharmacokinetic studies• Weekly Travel on average was 75%, regionally based with occasional nationwide travel as necessary.• Train clinical site personnel on protocol-specific requirements, including the use of electronic data capture systems (EDC)

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• Conduct Interim visits per GCP, FDA Code of Federal Regulations and ICH guidelines• Review and verify case report form data against source documents for accuracy and validity, ensure protocol compliance and function as the main study liaison between clinical sites and clients.• Train site personnel; assist sites in obtaining IRB approvals, prepare requisitions for shipment of drug supplies, review regulatory documents and general site management.

Date of Employment:

07/2012 -10/2013

Name of Employer: ICON Clinical Research, Inc.Job Title: Home based Senior Regional Clinical Research Associate IIIKey Responsibilities: • Conduct site qualification, initiation, interim monitoring, and

study closeout visits for Phase II-III trials in accordance with federal regulations, Good Clinical Practice (GCP) and ICH Guidelines.• Weekly Travel of 65-70% in the Northeast and Southeast Regions.• Managed 9 clinical sites and perform an average of 10 site visits per month.• Validate data submitted from study sites and ensure timely submission of data including appropriate reporting and follow-up for all safety events by site personnel.• Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project study teams.• Mentor CRA I and II staff via co-monitoring visit with these staff, as requested by CRA manager.• Assist Clinical Team Leads with document review as requested.

Date of Employment:

07/2010 – 08/2012

Name of Employer: QuintilesJob Title: Home based Senior Regional Clinical Research Associate IIIKey Responsibilities:

• Provide clinical monitoring services for multi-therapeutic phase III and IV clinical trials including pharmacokinetic studies• Weekly Travel on average was 75%, regionally based with occasional nationwide travel necessary for Site Initiation Visits.• Train clinical site personnel on protocol-specific requirements, including the use of electronic data capture systems (EDC)• Conduct Interim visits per GCP, FDA Code of Federal

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Regulations and ICH guidelines• Review and verify case report form data against source documents for accuracy and validity, ensure protocol compliance and function as the main study liaison between clinical sites and clients.• Train site personnel; assist sites in obtaining IRB approvals, prepare requisitions for shipment of drug supplies, review regulatory documents and general site management.

Date of Employment:

05/2005-07/2010

Name of Employer: PAREXEL International, Inc.Job Title: Home based Senior Regional Clinical Research AssociateKey Responsibilities:

• Monitored Phase II-IV clinical trials including site management in accordance with ICH-GCP Guidelines.• Weekly Travel of 70% in the Northeast Region.• Conducted pre-study, initiation, interim and closeout visits, including: Prepared accurate responses to audit findings in a timely

manner. Reviewed Informed Consent Forms for proper execution. Reviewed Case Report Forms (CRFs) against source

documents, and verified in remote data capture system. Raise appropriately written queries to sites, and verified

query responses. Completed and correctly documented study drug

reconciliation. Prepared accurate responses to any audit findings in a timely

manner. Assisted Clinical Team Leads by performing CRA trip report

review. Functioned as mentor and advisor to newer CRAs in training

at PAREXEL, 2006 – 2008. Functioned as Back-Up CRA assessor at PAREXEL,

evaluating performance of other CRAs, 2009 – 2010

Date of Employment:

01/2004-04/2005

Name of Employer: Advanced Clinical ServicesJob Title: Clinical Research Consultant/Retrospective ReviewerKey Responsibilities:

Completed retrospective data retrieval and review for a closed study, in conjunction with an FDA audit.

Visit reports were completed as needed. Worked with sites to resolve complex issues identified during

the course of the retrospective review.

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Employment History – Nursing: Senior Medical Case Manager – 13 years

Surgical Intensive Care Staff Nurse –3 years

Emergency Department & Coronary Care Unit Staff Nurse – 6 years

Education: Professional Nursing Diploma, St. Francis General Hospital School of Nursing, B.S., Health Arts, University of Saint Francis, Joliet, IL, Continued attendance at numerous continuing education seminars, (CES) at

PAREXEL, Quintiles, ICON, and ACRP over several years. CRA the Pfizer Way on site CRA sponsor program attended on site, 2008. Clinical Lead Training attended at PAREXEL via WebEx sessions, 2009-2010

Certifications:ACRP Certified Clinical Research Associate obtained – September, 2008, maintained since.ACRP - Served as a second level application reviewer for CPI, CCRA, and CCRC applicants from October, 2013 – March, 2014 season.

Professional Licensure:PA Professional Nursing License - current

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