Sr. Clinical Research Associate/ GCP QA Auditor

Jory Enzler, BA

Ridgeway, VA

984-***-**** (ph)

********@*****.***

PROFILE and EXPERIENCE SUMMARY

Professional with experience in GCP/ QA auditing, clinical trial monitoring, personnel management, coordination assistance on several protocols in Phase I through IV clinical trials, including investigator assessment, site qualification/initiation, clinical monitoring, regulatory review, drug accountability, study close- out, and all applicable sponsor and site correspondence. Emphasis on compliance with FDA, EMEA, ICH and GCPs regulations. Some highlights of my experience, which support my career goals, include the following skill sets:

Member of American Society of Quality (ASQ)

Member of Society of Quality Assurance (SQA)

Member of Rocky Mountain Regional Chapter Society of Quality Assurance (RMRCSQA) Excellent organizational and communication skills

Study start- up and problem solving

Ability to monitor in a complex environment and multiple protocols Managed 6-8 CRAs depending on study needs

Worked with financial group to forecast study budgets and out of scope changes Completed bid defenses, Investigator meetings and kick off meetings Trained and evaluated monitors on Site Pre-Study, Initiation, Interim Monitoring and Close-Out Visits. CNS Scale experience multiple but not inclusive (MMSE, NPI, ADAS-COG, MADRS, CGIS, DAD, DSS, CDR, Hachinski, CGIC, DQOL)

EDC experience (Oracle, eCaselink, eTarget, Medidata, Rave, Medrio, Impact, Nextrials and InForm) Certified InForm Trainer in 2009

ARISg Trainer

GCP/ QA auditor (Site’s, CRO’s, Biotechnology and Pharmaceutical companies) THERAPEUTIC EXPERIENCE (years experience/ # of protocols) Cardiology – Myocardial Infarction, In-Patient (2/2) Central Nervous System – Alzheimer’s (4.5/5), CADASIL (2/1), Schizophrenia (2/1), Alcohol Dependence (1/1), Parkinson’s Disease (1/1) Dermatology – Psoriasis (1/1)

Device – Cardiology stent (1/1), Pain Management (1/1) Endocrinology – Diabetes Mellitus Types I and II (3/3), Obesity (1/2) Genitourinary/ Gastrointestinal – Post Operative Nausea Vomiting; In-Patient (1/1), Gastroparesis (1/1), Ulcerative Proctitis/ Proctosigmoiditis (1/2), Irritable Bowel Syndrome (1/1), Benign Prostatic Hyperplasia (.5/1), Necrotizing Enterocolitis (1/1) Infectious Disease – Herpes Simplex Virus (1/1), Hepatitis C (1.5/1) Oncology – Lymphocytic Leukemia (1.5/1), Acute Myeloid Leukemia (1/1), Metastatic Castration-Resistant Prostate Cancer (2.5/2), Pain Management (1/1), Breast Cancer

(2/2), Pancreatic Cancer (1.5/2), Upper Urinary Tract Urothelial Cancer (1/1), Kidney

(1/1)

Ophthalmology - Glaucoma Diabetic Retinopathy (3/2), Dry Eye (2/2), Nystagmus

(1/1), Hyperopia (4/2)

Respiratory – Asthma (3.5/6), COPD (1.5/1) Perennial Allergic Rhinitis (2/2), Seasonal Allergic Rhinitis (2/2)

Urology – Overactive Bladder (1/1)

Oversight CRA – (2/4)

Phase I – Diabetes (2/2), Oncology (1/1), Tobacco (1/2) S.W.A.T. – 3 years inclusive / 5 studies

EDUCATION

B.A., Biology, May 2001

Randolph-Macon College, Ashland, VA

A.S., Science, May 1999

Danville Community College, Danville, VA

PROFESSIONAL EXPERIENCE

CCR Biotech, LLC – Raleigh, NC Independent Consultant March 2015 - Present

Manage clinical investigator sites, site evaluation and initiation, data collection and quality control review of data collected at trial sites to ensure compliance with multiple protocols, FDA regulations and ICH/GCP guidelines for Phase I - IV trials. ICH/ GCP Quality Assurance Auditor for Site’s, CRO’s and Pharmaceutical companies. Responsibilities included but not limited to:

Conducted site and internal TMF audits for CROs and Pharmaceutical companies in accordance to EMEA, FDA and ICH/GCP regulations

Conducted site audits for CRO’s and Pharmaceutical companies in accordance to EMEA, FDA and ICH/GCP regulations

Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements Trained CRAs and sites in InForm

Reviewed Trip reports, expense reports and approved time sheets Trained/Mentored junior CRAs on monitoring (Pre-Study, Initiation, Interim and Close- Out Visits), internal procedures, and query resolution Trained CRAs and investigators/ investigative sites with EDC Trained junior colleagues in completing ARISg and MedWatch Reports Oversight CRA on multiple projects and therapeutic areas Recruited investigators for participation in clinical trials Negotiated study budgets with investigators/investigative sites Obtained, reviewed for appropriateness, and processed regulatory and administrative documents from investigator sites

Reviewed draft protocols for completeness and feasibility Reviewed draft ICFs for completeness and feasibility Reviewed draft Source Documents for completeness and feasibility Reviewed and verified CRFs and other clinical data, for completeness and accuracy; generate queries.

Resolved queries of CRF data with the study personnel Reviewed Tables and Listings generated from study data Maintained project tracking systems of subject and site information Performed routine site visits, including Pre-Study (Greater 500), Initiation (Greater 500), Interim Monitoring Visits (Greater 1000), and Closeout visits (Greater 500). Visits to include monitoring of proper informed consent procedures, compliance with protocol, ICH/GCP Guidelines, and other applicable regulatory requirements, and assurance of good site performance

United Therapeutic, Inc. – RTP, NC Auditor, GCP Quality Systems June 2020

– July2021

Manage and assist in implementing and maintaining a comprehensive risk based GCP compliant quality program.

Manage and assist in setting annual audit schedule and preparing necessary budget. Manage and conduct external site, vendor, and commercial partner audits according to United Therapeutics SOPs. Review and approve audit responses and evaluate adequacy of corrective and/or preventative actions. Provide support during global regulatory agency inspections and other audits of RTP and EU offices. Identify and assist in developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements. Manage and conduct internal clinical process audits according to United Therapeutics SOPs. Perform quality reviews of clinical study reports and supplemental study documentation, as needed. Provide audit reports to system/process owners and Quality System Management. Perform document record review including, general study files and site-specific study files in area of responsibilities. Provide summary reports to management of audit activities. Assist in the coordination and conduct of functional area/departmental programs. Coordinate activities of contract or compliance consultants as necessary. Perform other duties as assigned. Interact with all departments including but not limited to Global Clinical Operations, Global Drug Safety, QPPV Office, Medical Information and Medical Affairs, Quality Systems and Compliance, Quality Control (QC) Oversight and Standards, Training, Product Development, Pharmaceutical, Development, Biostatistics and Data Management, and Regulatory Affairs, etc. Interact with site and vendor personnel as necessary to plan and conduct above audits. Accelovance, Inc. – Durham, NC Clinical Trial Manager 2014– 2015

Work with Project Manager (PM) to define program targets for clinical operations staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP

Serve as client advocate within Accelovance

Develop and implement Clinical Operations Plan, ICFs and Protocols Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes

Coordinate site management activities

Site identification, recruitment, and selection

Regulatory document collection and review

Overall scheduling and management of all site visits Develop site/monitoring tools and training materials Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions Coordinate and oversee daily operations of clinical operations team Manage project milestones and proactively address deficiencies Trained, Mentored and Managed CRA performance

Documentation Duties/Responsibilities

Budget/Contract Duties/Responsibilities

JCE Clinical, Inc., Raleigh, NC Independent Consultant 2007

– 2014

Manage clinical investigator sites, site evaluation and initiation, data collection and quality control review of data collected at trial sites to ensure compliance with multiple protocols, FDA regulations and ICH/GCP guidelines for Phase I, II and III trials. Clients have included CROs (3 years), Small Biotechnology (2 years), and Large Pharmaceutical companies (4 years). ICH/ GCP Quality Assurance Auditor for Site’s, CRO’s and Pharmaceutical companies. Responsibilities included but not limited to: Performed routine site visits, including Pre-Study (Greater 500), Initiation (Greater 500), Interim Monitoring Visits (Greater 900), and Closeout visits (Greater 500). Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.

Conducted site and internal TMF audits for CROs and Pharmaceutical companies in accordance to FDA and ICH/GCP regulations.

Conducted site audits for CRO’s and Pharmaceutical companies in accordance to EMEA, FDA and ICH/GCP regulations

Oversight CRA on multiple projects and therapeutic areas. Presented and conducted on bid defenses, out of scope budget changes and study kick-off meetings.

AAI Pharma, Raleigh, NC Lead CRA 2006

– 2007

CRA: Clinical Research Associate monitoring on Phase I clinical trials. Participated in the conduct of multi-center clinical research studies; reviews project-related materials and literature to develop a basic understanding of the protocol and therapeutic areas; participates in kick-off meetings for assigned studies; assists in investigator recruitment; evaluates, initiates, monitors and closes out sites according to applicable Standard Operating Procedures (SOPs) and FDA guidelines; reviews case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements; resolves CRF discrepancies and/or clarifications via site visit, telephone, or fax as deemed appropriate for the study; performs drug accountability, ensures prompt reporting of adverse events; and verifies completeness of critical documents.

PAREXEL International Corporation, Raleigh, NC Sr. CRA, CRA II 2005

– 2006

CRA: Clinical Research Associate on Phase II and III clinical trials. Responsibilities included maintaining a working knowledge and assure compliance with the GCPs, Federal Regulatory requirements, and SOPs; clinical trials monitoring; data collection at trial sites to ensure compliance with multiple protocols; site evaluation and initiation; compare source documentation against case report forms to ensure data is verified; report all adverse events in a timely manner as defined by client contracts and FDA regulations; initiate investigational sites; keep ongoing records of status of sites and patients; completing monitoring and other routine reports as required; qualifying potential investigators. Pharmanet Inc., Cary, NC CRA II 2004

- 2005

CRA: Clinical Research Associate on Phase II and III clinical trials. Participated in the conduct of multi-center clinical research studies; reviews project-related materials and literature to develop a basic understanding of the protocol and therapeutic area; assists in investigator recruitment; evaluates, initiates, monitors and closes out sites according to applicable Standard Operating Procedures (SOPs) and FDA guidelines; reviews case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements; resolves CRF discrepancies and/or clarifications via site visit, telephone, or fax as deemed appropriate for the study; performs drug accountability, ensures prompt reporting of adverse events; and verifies completeness of critical documents.

PPD Development, Raleigh, NC CRA II 2003 -

2004

CRA I 2002 -

2003

CRA: Clinical Research Associate monitoring on Phase II and III clinical trials. Participated in the conduct of multi-center clinical research studies; reviews project-related materials and literature to develop a basic understanding of the protocol and therapeutic areas; participates in kick-off meetings for assigned studies; assists in investigator recruitment; evaluates, initiates, monitors and closes out sites according to applicable Standard Operating Procedures (SOPs) and FDA guidelines; reviews case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements; resolves CRF discrepancies and/or clarifications via site visit, telephone, or fax as deemed appropriate for the study; performs drug accountability, ensures prompt reporting of adverse events; and verifies completeness of critical documents. Scientific Laboratories Inc., Richmond, VA

Transmission Electron Microscope (TEM) Analyst, Chemical Hygiene Officer 2001 – 2002

Responsible for analyzing water, dust, bulk, and air samples for asbestos. Was responsible for meeting OSHA requirements, fire and security, chemical disposal and the safety for 30+ employees.

Conducted confidential research experiments for a governmental agency. Analyzed air samples for FEMA for the 9-11-2001 occurrences (The first and only company to conduct TEM analysis).

Johnston-Willis Hospital, Richmond, VA

Emergency Room Technician

2000 – 2001

Trained 15+ personnel on technique, policies and procedures in the Emergency Department. Assisted doctors during various procedures, such as suturing, chest tube insertion, etc. Provided treatment to patients with life threatening emergencies. Proficiency in phlebotomy and other technical skills. Administered medications, performed electrocardiograms, and additional procedures. Responsible for documenting procedures in patient’s source documents. Randolph-Macon College, Ashland, VA

Teaching Assistant, Biology Department

2000 - 2000

Responsible for teaching biological lab techniques to 20+ students for a General Biology Lab class. Was Responsible for preparing all labs, obtaining proper biological supplies, and answering all student questions and concerns. Cool Branch Rescue Squad, Penhook, VA

Emergency Medical Technician Volunteer

1998 – 2000

Actively volunteered numerous hours, providing basic life support care to patients. Conducted training for new and veteran members. Conducted physical exams, documented findings and procedures. Conducted various medical procedures. Administered medications to patients. United States Coast Guard, New London, CT

Dental Technician 1995 –

1997

Responsible for assisting Dentists in oral surgery, tooth restoration and cleaning, teaching laboratory techniques and patient care to senior dental school students. Participated in a Sports Guard research study involving military personnel. Obtained written consent from all personnel participating in the research study. Conducted patient physical examinations. Maintained 1000+ dental records; ensured military personnel were medically cleared for operational deployment. United States Coast Guard, Alameda, CA

Federal Law Enforcement Agent/Search and Rescue 1992 – 1995

Responsible for enforcing all federal and international watercraft laws and conducting drug interdiction searches.

Member of JTF5: JTF-5 was created under the National Defense Authorization Act for Fiscal Year 1989. Title 10 of the U.S. Code Section 124 was signed into law on 19 November 1989 establishing the Department of Defense (DoD) as the lead agency for the Detection and Monitoring (D&M) of maritime and aerial drug trafficking into the United States directing the DoD to support of U.S. Law Enforcement counter drug efforts and worked under RADM John L. Linnon, USCG. LICENSES & CERTIFICATIONS

Emergency Medical Technician, Basic, VA, Cert#: 521150425 BLS for Healthcare Providers, American Heart Association Nationally Registered Emergency Medical Technician Saf-T-Pak (Ability to ship dangerous goods)

InForm Trainer

ADDITIONAL RELEVANT EXPERIENCE

MS Windows, MS Word, Word Perfect, Excel, Access, Anova, Unistat, MS Works, MS Powerpoint, Adobe Acrobat, Lotus Notes, CTMS, eTarget, Veeva Vault, PhlexEview, Master Control, TrackWise Digital, Wingspan, Medrio, Mediata, Rave, InForm, Suvoda, Infosario PROFESSIONAL DEVELOPMENT

U.S. Coast Guard Training Center Petaluma Petaluma, CA, Dental Technician, August 1995

PROFESSIONAL AFFILIATIONS

American Society for Quality, (ASQ) 2020 – Present Society of Quality Assurance, (SQA) 2017 – Present Rocky Mountain Regional Chapter Society of Quality Assurance (RMRCSQA) 2017 - Present

Member of the Wake County Historical Society, 2003 - Present Virginia Academy of Science, 2001-2002

PUBLICATIONS AND PRESENTATIONS

Publications:

Enzler, J., Conway, C., Conway, A. 2001. Involvement of blood clotting in pregnancy loss induced by lipopolysaccharide injection in CD-1 mice. VA. J. Sci.: 52: 83. Presentations:

James Madison University, Virginia Academy of Science, Department of Biology, May 2001. Involvement of blood clotting in pregnancy loss induced by lipopolysaccharide injection in CD-1 mice.

Research, Department of Biology, Randolph-Macon College, Jan 2001-May 2001. Involvement of blood clotting in pregnancy loss induced by lipopolysaccharide injection in CD-1 mice.

Research, Department of Biology, Randolph-Macon College, Sept 2000 – December 2000. Involvement of microspheres with macrophages in the Peyers Patches of the small intestine in CD-1 mice.

Research, Department of Biology, Randolph-Macon College, Sept 2000 – December 2000. Involvement of genetic traits in Drosophila Melanogaster in an experimental environment.

Jory Enzler, BA Page PAGE 2

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