Patrick A. Jordan 3112 Ridgestone Parkway p.l.jordan1999@gmail.com Durham, NC 27712

(C) (919)257-8983

Professional Experience • Possess strong leadership, project management, coordination, and organizational skills • Strong knowledge of clinical research principles, practices, and methodologies • Extensive knowledge of FDA regulations, ICH guidelines, GLPs, GCPs, and SOPs • Monitoring experience – national and international travel for SIV, IMV, and COV • Experience with resolution of queries, data maintenance, and data cleaning for close-out • Strong protocol start-up, logistical, and application skills • Attention to detail resulting in quality deliverable within the desired timeline • Ability to identify issues and resolve appropriately • Experience in multiple EDC systems and platforms • Strong clinical background in diagnostic/prognostic testing and monitoring of various diseases • Therapeutic experience in Oncology, Hematology, Orthopedics, GI, Cardiology, Multiple Sclerosis,

and ADHD • Experience with start-up and late-phase clinical processes in PH II, III and IV trials • Excellent teaching, mentoring, and team development skills • Strong communication and interpersonal skills

Education • Candidate for Masters of Clinical Research (2016), Campbell University, Buies Creek, NC

• Bachelor of Science, Business Administration/Math, Wingate College, Wingate, NC

Professional Experience Clinical Operations Rho, Inc. 10/2014-09/2015 CRA I

● Performs monitoring visits such as SQV, SIV, IMV, and COV

● Ensures the integrity of clinical data and adherence to applicable FDA regulations, ICH guidelines,

protocol, and Company guidelines

● Ensures the rights, safety and wellbeing of clinical trial subjects is maintained

● Collaborates with the Core Project Team and site staff to drive subject recruitment

● Prepares site visit reports, confirmation and follow-up letters, and other monitoring documentation as

required

● Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure

compliance with applicable regulations and the protocol (primary point contact for site staff)

● Responsible for maintaining knowledge applicable to the protocol, indication, and job ● Regularly attends and participates in project team meetings

DCRI Duke University Medical Center 03/2014-07/2014 CRA II

● Perform site feasibility follow-up interviews and prepare documentation for ARLG site selection

● Construct and update ARLG Combined Site Tracker with all possible site contact information for all

ARLG protocols

● Primary contact of the clinical team for designated project communications and correspondence with

sites, vendor, and internal team personnel

● Responsible for coordinating the shipment of reagents and supplies to trial sites

● Perform assigned administrative tasks to support team members with team meetings, timelines, and

clinical operations

● Attend and participate in project team meetings with input on protocols regarding clinical operations

● Responsible for protocol and site metrics of ongoing clinical trials

Ockham Contractor at Quintiles 12/2013-03/2014

CTA

● Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating

and maintaining clinical systems that track site compliance and performance within project timelines

● Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical

documentation and reports according to the scope of work and standard operating procedures

● Assist with periodic review of study files for accuracy and completeness

● Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of

tracking information

● Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow

● Assists with tracking patient enrollment, site data, CRF, ICF, as required

● Act as a central contact for the clinical team for designated project communications, correspondence

and associated documentation

● Perform assigned administrative tasks to support team members with clinical trial execution Regularly

attends and participates in project team meetings

Pinnacle Technology Contractor at BectonDickinson 07/2013-08/2013 CRA II (Short Contract)

● Monitors assigned sites for compliance to protocol and regulations

● Prepares site visit reports, confirmation and follow-up letters, and other monitoring documentation as

required

● Performs monitoring visits such as site evaluation, SIV, IMV, and COV

● Reviews and verifies informed consent process and forms, study subject data in CRFs to source

documents, resolves data queries, and ensures device and study accountability

● Performs trial coordination and activities (e.g. unanticipated adverse event management, data

verification) as required

● Assists with tracking patient enrollment, site data, CRF, ICF, as required

● Facilitates the distribution of supplies, forms, equipment, and study devices to sites. Assists with

distribution of study materials to sites and/or CROs as applicable

● Oversee CRO and CRA site management and monitoring as applicable

● Regularly attends and participates in project team meetings

● Assists the project team in the development of plans and protocols for studies

● Assists with design and review of informed consent form templates, case report forms and

instructions, site selection materials, procedural manuals, project newsletters, and other project-

specific documents

● Works with team to ensure FDA regulatory documents are acquired and appropriately completed, as

well as follow-up on deficiencies and assist with maintenance of study files

● Draft memos, reports, documents, and correspondence to assist in the management and coordination of

the study

● Assists with review of site training material, study data, and reports

Aerotek Contractor at bioMerieux 01/2013-07/2013

Clinical Scientist (Short Contract)

● Responsible for clinical operations of site set-up, equipment, and training ● Responsible for all CRA duties including In-house monitoring, SIV, IMV, and COV for domestic and

international clinical trials ● Instrumental involvement in product PMA approval by FDA ● Monitor and problem solve reference laboratories to ensure compliance with FDA regulations, ICH

guidelines, and GLP ● National and international monitoring experience of sites for data maintenance and query resolution ● Active liaison between partnership sites and reference laboratories maintaining positive working

relationships to obtain the desired goals ● PCR (BRAF) Proficiency certified and signed-off for SIV, IMV, and COV ● Participate in team, laboratory, and partnership meetings to proactively problem solve possible

problems and enhance the efficiency of the protocol procedures ● Responsible for managing clinical trial files to support regulatory compliance and submissions

Department of Medicine-Hematology Duke University Medical Center 2008-2013 Clinical Research Coordinator II

● Develop, plan, and implement clinical trial protocols with principal investigators, staff, multiple

departments, and outside vendors

● In-house monitoring duties for satellite sites (Mayo Clinic, University of Wisconsin, UNC, and VA

Hospitals) for multi-year NIH funded/sponsored clinical trial

● Coordinate all aspects of the clinical trial from presentations, regulatory interactions, laboratory functions and involvement to data coordination and finalization of the trial

● Screen, recruit, and collect desired deliverables for protocol ● Recruitment responsibilities for institutional, industry/pharma, and federal clinical trials including

MOP development and implementation ● Developed advertising and marketing materials for new and ongoing protocols to achieve desired

enrollment ● Assisted various other sites and cardiology groups with enrollment strategies ● Lectured and lead break out group at several notional PI/CRC meetings regarding enrollment

strategies ● Review scientific literature for understanding of scientific material, procedures, and new

developments with regards to current protocols ● Communicate effectively to all parties involved so the trial will be as efficient and safe as possible

and to ensure that all SOPs, FDA regulations, and ICH guidelines are followed ● Perform QC/QA on assigned protocols

PRMO/Clinical Trials Duke University Health System 2006-2008 Patient Account Analyst

● Analyze accounts using the operating systems, Clinical Trials Registry, and Grids to ensure

accuracy

● Research all aspects of an account included but not limited to insurance, diagnosis, procedures, services performed, fund and ICD9 codes

● QA accounts in Hyland Onbase from the CRSO/CTBO team ● Perform charge move transactions as necessary for compliance with CRC and customer service

requests ● Investigate accounts and coordinate changes to accounts/clinical trial grids with CRSO/CTBO team

members and external customers ● Record quality and performance of CRSO/CTBO team members ● Perform. daily reports arid cover off duty personnel-'s duties as necessary ● Train and cross train with personnel inside the clinical trial department

Operations/QC J & G Exteriors, LLC 1997-2006 Project Manager

• Develop and oversee all proposals, contracts, and accounting • Develop and maintain internal and external relationships • Managed projects from proposal through completion • Maintained good customer service practices and policies • Developed and trained all personnel • Performed QA/QC on all projects • Analyzed and implemented policies and procedures to ensure efficiency and achievement of

company goals

Marketing and Sales Ventana Medical Systems 1993-1997

Technical Marketing Representative-Southeast Region

• Developed and implemented technical and safety training for all the hospital laboratory accounts in

the Southeast region

• Developed, coordinated, and implemented nationwide oncology research in Jacksonville Memorial Women's Cancer Center, Duke University Cancer Center, NIH, Armed Forces Institute of Pathology, University of Colorado Cancer Center, University of Arizona Medical Center, and Cleveland Clinic.

• Responsible for QA/QC in all of the laboratories • Developed protocols and training to achieve all national testing accreditation (CAP, JCAHO, etc.) • Maintained all necessary national certifications • Organized and instructed seminars on local, regional, and national levels

Cell Imaging Lab Duke Cancer Center 1986-1993 Laboratory Technologist

• Developed and coordinated research projects with principal investigators, clinical trials, and

laboratory staff

• Responsible for all aspects of the immunohistochemistry laboratory including productivity,

• QA/QC, safety, and training

• Review journals, abstracts, and publications pertaining to research • Analyzed, organized, and discussed data of research projects with principal investigators • Coordinate and collaborate on the preparation of manuscripts for publication

Publications

1. Kerns BJ, Jordan PA, Moore MB, Humphrey PA, Berchuck A, Bast RC, Iglehart JD, and Marks

KR: p53 Overexpression in formalin-fixed paraffin embedded tissue detected by immunohistochemistry. J Histochem Cytochem 40:1047-1052, 1992.

2. Jordan PA, Kerns BJ, Pence J, Berchuck A, Bast RC, and Kinney R: Determination of proliferation index in advanced ovarian cancer using quantitative image analysis. American iournal of Clinical Pathology 99:736-740, 1993.

3. Herzberg AJ, Garcia JA, Kerns BJ, Jordan PA, Pence JC, Rotter SM, and Dzubow LM: DNA ploidy of basal cell carcinoma determined by image cytometry offresh smears. Journal of

Cutaneous Pathology 20(3):216, 1993.

4. Kern BJ, Jordan PA, Faerman LL, Berchuck A, Bast RC, and Layfield LJ: Determination of

proliferation index with MIB-1 in advanced ovarian cancer using quantitative image analysis. American Journal of Clinical Pathology, 1993.

5. Kerns BJ, Jordan PA, Huper G, Marks JR, Iglehart JD, and Layfield LJ: Assessment of c-erb2 amplification by immunohistochemistry in paraffin embedded breast cancer. Modem Pathology 6(6):673, 1993.

Seminars/Workshops

1. Kerns BJ and Jordan PA: Image Cytometry- What the Histotechno1ogist Needs to Know! Workshop #4, National Symposium ofHistotechnology, Monterey, California, 09/12/92.

2. Jordan PA and Conlon DH: Proliferation Index: Theory, Methodologies, and Practices. Workshop #88, National Symposium ofHistotechnology, Philadelphia, Pennsylvania, 10/05/93.

3. Jordan PA: Histology: Old Meets New. Workshop #2, Mississippi State Society Meeting, Hattiesburg, Mississippi, 11/95.

4. Jordan PA: Histology: Old Meets New. Workshop #SA; Cancer: Who, What, and How? Workshop #5B, Georgia Society for Histotechnology State Meeting, Athens, Georgia, 02/96.

5. Jordan PA: Histology: Old Meets New. Workshop #7, NSH Region III Meeting, Birmingham, Alabama, 03/96.

6. Jordan PA: Histology: Old Meets New. Workshop #10, Kentucky Society State Meeting, Louisville, Kentucky, 03/96.

7. Jordan PA: Troubleshooting Immunohistochemistry. Workshop #2, A Practical Workshop on Immunohistochemistry, Deerfield Beach, Florida, 11/96.

8. Jordan PA: Cancer: Who, What, and How? Workshop #2, Florida Mid-Region Society Meeting, Bradenton, Florida, 01/97.

Poster Presentations

1. Kerns BJ, Jordan PA, Herzberg A, and Kinney R: DNA Ploidy and Proliferation Index of Soft

Tissue Sarcoma. NSHPoster Session, Ordando, Florida, 09/28/91.

2. Kerns BJ, Jordan PA, and Kinney R: Quantitative DNA Analysis and Proliferation Index. NSH Poster Session, Orlando, Florida, 09/28/91.

3. Jordan PA, Kerns BJ, Whitaker R, Berchuck A, Bast RC, and Kinney R: Proliferation Index in

Ovarian Cancer Determined by Ki-67 Immunostaining. NSH Poster Session, Orlando, Florida, 09/29/91.

4. Bast RC, Kerns BJ, MacDonald JA, Jordan PA, Boyer CM, Mendelsohn J, and Berchuck A:

Coexpression of the c-erb2 (Her-2/neu) Gene Product (p185) and Epidermal Growth Factor Receptor (p170) on Epithelial Ovarian Cancers and Normal Tissues. Poster Session and

Discussion at the AACR, San Diego, California, 05/22/92.

5. Kerns BJ, Layfield LJ, Jordan PA, Conlon DH, Huper G, Marks J and Iglehart JD: Assessment

of c-erb2 Amplification by Immunohistochemistry in Paraffin Embedded Breast Cancer. Poster presentation American Academy of Cancer Research- Abstract #1344, 05/19/93, Clinical Investigations Section 4, Orlando, Florida.

6. Ibrahim S, Amling C, Ibrahim G, Jordan P, Robertson C, and Vollmer R: Micro vessel Density in Prostate Cancer: Relationship to DNA Ploidy, Proliferation Index, Gleason Grade, and Histologic

Stage. 82"d United States and Canadian Academy of Pathology. New Orleans, LA, 93.

7. Layfield LJ, Jordan PA, Conlon DH, and Kerns BJ: determination of Proliferation Index with MIB-1 in Advanced Ovarian Cancer Using Quantitative Image Analysis. ASCP, 93.