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Natalie Mahan CCRC, COA

Senior Clinical Research Coordinator

The retina institute

ad46hg@r.postjobfree.com

** ****** **

Old Monroe MO 63369

609-***-****

PROFESSIONAL EXPERIENCE:

Ophthalmic Surgical Coordinator

(November 8 2021- current)

Retinal and Ophthalmic Consultants P.C., Northfield NJ Direct Report to the Practice Manager

• POSITION SUMMARY: The Surgical Scheduler is responsible for scheduling surgeries for assigned physician(s).

• Responsibilities include coordinating surgical procedures with multiple hospitals and surgery centers, scheduling and obtaining pre-operative testing, writing and communicating surgery orders, and collecting necessary documentation for surgeries. This individual works closely with patients, physicians, and surgery location to providing accurate, timely, and responsive paperwork.

• ESSENTIAL FUNCTIONS - PRINCIPAL DUTIES AND RESPONSIBILITIES: • Coordinates and schedules surgeries, follow-up appointments as designated by physicians. • Interacts with patients’, physicians and other staff both within the Clinic and at outside facilities providing accurate, timely and responsive information. • Coordinates processes and routes all paperwork as required to meet physician and facility requirements. • Ensures efficient telephone communication. • Documents work processes as required.

• Follows all written protocols and procedures of the Clinic. • Demonstrates courtesy and helpfulness toward patients and their families. • Must be able to recognize and respond appropriately to urgent/emergent situations per protocols. • Establish and maintain effective working relationships with physicians, staff, and management. • Books surgeries based on physician volume maintaining appropriate standard turn- around times. • Identifies scheduling barriers and implements solutions to improve scheduling results based on predetermined goals. • Follow established REI and surgery center/hospital precautions and procedures in the performance of all job duties to ensure a safe work environment. Adhere to policies regarding safety, confidentiality and HIPPA guidelines

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Imaging Research Associate (23 April 2021-October 2021) Thomas Jefferson University

DEPARTMENT: Annesley Eye Brain Center /Farber Institute 100% remote position 6 month contracted role

Reports Directly to Study Processing Manager or Study Data Manager

• The Imaging Research Associate coordinates all imaging operational activities, from study start to study close, to ensure the timely delivery of high quality images service deliverables for assigned studies. Study Processing Specialists are assigned to process stations as needed and specific responsibilities will vary based upon the process station to which the individual is assigned.

• Perform quality assurance review of incoming and outgoing study materials, liaise with quality reviewers, ensure accurate data processing and packaging of materials for physician readers

• Communicate feedback on submissions and issue queries to clinical sites regarding image quality, data discrepancies, assessment results and changes in image collection procedures, on a timely basis

• Perform data entry, conflict resolution and run reports analyzing measurement changes over time

• Prepare materials and communicate issues with Quality Reviewers and Physician Readers

• Monitor and report adverse events and clinical alerts to the AEBC study project manager on a timely basis

• Ensure timely processing of records in data transfers and support data management with edit check and outlier review.

• Communicate with AEBC Study Processing Manager regarding operational deliverables on assigned studies.

• Monitor and report issues affecting site management and data processing to the AEBC Study Project Manager and Study Processing Manager

• Participate in creation and distribution of clinical site training materials (i.e study specific manuals, slides and videos) and sponsor/clinical site reports

• Participate in internal and external audits

• Assist with study close-out procedures

• Provide special project support, as needed

Senior Clinical Research Coordinator (17 August 2020- 05 March 2021) South Jersey Infectious Disease 730 Shore road Somers Point NJ 08244 Reported Directly to the Principal Investigators

• Administered the informed consent process

• Coordinated clinical trials ensure patient safety and research data validity/reliability in accordance with GCP standards and FDA regulations

• Performed various rating scales according to protocol guidelines

• Transcribed source documents onto CRFs

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• Monitored and reported sponsor queries, protocol violations, adverse events, and serious adverse events, and QA of chart

• Performed Study Visits and monitoring visits

• Performed Phlebotomy, vital signs, nasal swabs

Senior Clinical Research Coordinator (May 17 2018 - August 15 2020) Accelerated Enrollment Solutions (formerly Synexus Clinical Research US, Inc.), Bridgeton, NJ Direct Report to the Principal Investigators and Site/Regional Directors and Corporate Headquarters in Tempe, AZ

• Coordinated 6 clinical trials ensure patient safety and research data validity/reliability in accordance with GCP standards and FDA regulations

• Study start up, regulatory IRB submissions, site budget, study close outs

• Investigational product accountability

• Created source documents for study visits

• Administered the informed consent process

• Travelled to other sites to help with understaffing

• Transcribed source documents onto CRFs

• Monitored and reported sponsor queries, protocol violations, adverse events, and serious adverse events, and QA of charts

• Preformed various elements of clinical trial: EKG, Vitals, Phlebotomy

• Enhanced study recruitment/retention, scheduled meetings bi-weekly with site investigators and staff on current study statuses

• Completed Study visits

Clinical Research Manager (January 2013-May 2018)

Retinal and Ophthalmic Consultants P.C., Northfield NJ Reported Directly to the Principal Investigators and Practice Manager

• Coordinated 9 clinical trials ensure patient safety and research data validity/reliability in accordance with GCP standards and FDA regulations.

• Made source documents, SOP’s, ensured research staff, maintained certifications and trainings

• Responsible for patient recruitment efforts/enrollment goals.

• Study start up, regulatory IRB submissions, site budget, study close outs

• Investigational product accountability

• Created source documents for study visits

• Identified all studies and future studies for the Investigator(s) and site.

• Managed research assistant and 2 other research staff 4

• Administered the informed consent process, performed all study visits

• Transcribed source documents onto CRFs

• Monitored and reported sponsor queries, protocol violations, adverse events, and serious adverse events, and QA of chart

• Preformed various elements of clinical trial, EKG, vitals, entire study visits

• Certified Research Photographer

Clinical Research Coordinator (August 8, 2010- January 2013) Retinal and Ophthalmic Consultants P.C., Northfield NJ Direct Report to the Principal Investigators and Practice Manager

• Administered the informed consent process

• Coordinated clinical trials ensure patient safety and research data validity/reliability in accordance with GCP standards and FDA regulations

• Performed various rating scales according to protocol guidelines

• Transcribed source documents onto CRFs

• Monitored and reported sponsor queries, protocol violations, adverse events, and serious adverse events, and QA of chart

• Preformed various elements of clinical trial, OCT and ECG Certified Ophthalmic Assistant (December 18, 2006 – August 07, 2010) Retinal and Ophthalmic Consultants P.C., Northfield NJ Direct Report to the Technician Department Manager

• Actively assisted 6 doctors (Cornea, Glaucoma, Retina, Oculoplastics Specialists) with examinations and in-office surgical procedures

• Contributed to patient care during and after various office procedures

• Scribed patient notes during examinations, thus developing excellent dictation skills

• Preformed Diagnostic testing, Fundus Photography, Fluorscein Angiograms, OCT, Visual Fields, HRT, Pachymetry, etc.

Ophthalmic Technician (November 2003 – December 2006) Clarkson Eye Care, O’Fallon MO

Direct Report to Office Manager.

• Continually supported 3 doctors in exams and minor surgical procedures

• Pre-screened patients before doctor’s examinations

• Scribed patient notes during examinations

• Assisted in patient education and care

• Contact lens training on patients

• Dispensing glasses

• Visual fields, HRT, Fundus Photography, auto refractions, VA testing Education and Certifications

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2002-

2006 St. Charles Community College, St. Charles, MO Bachelors’ Degree in Biology

2008 CPR/AED Certification

2008 COA – Certified Ophthalmic Assistant

2012 Certified Research Photographer

2015 CCRC Certification

2018 PHLEBOTOMY Certification

2008 GCP, IATA, HIPPA, all research related training Therapeutic Expertise

*Diabetic Macular Edema *Neovascular Age-Related Macular Degeneration

*Non-Infectious Uveitis *Geographic atrophy Infectious Diseases

*Diabetic Retinopathy *Non-arteritic Anterior Optic Neuropathy

*Macular Degeneration *Men’s Health/Testosterone *Hypertension

*Vaccinations *Diabetes *cardiovascular disease

*HIV *COVID-19 *Hyperlipidemia *Non-Alcoholic Fatty Liver Disease Rating Scales Expertise

Visual Functioning Questionnaires DISF

PRO Questionnaires HIS-Q PSS PHQ-9

CLINICAL RESEARCH EXPERIENCE

Research Experience (Protocol Titles w/Phases)

2010 A Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of XXXXX Injection in subjects with clinically significant Macular Edema with center involvement secondary to Diabetes Mellitus. Genentech (RISE study - FVF 4170g)

2010 A Phase III, randomized, double-masked, active controlled study of efficacy, safety and tolerability of repeated doses of XXXXX in subjects with Neovascular Age-Related Macular Degeneration.

Genentech (View 1- VGFT OD-0605)

2010 A Phase IV B study of an open label, long term safety and tolerability extension study of XXXXX in neovascular age related macular degeneration. 6

Genentech (VGFT-OD 0605.) (VGFT-OD 0910) parent study 2010 Efficacy and Safety of 0.5mg AND 2.0mg XXXXX administered MONTHLY or AS NEEDED

(PRN). A Phase III double-masked multicenter, randomized, active treatment- controlled study of patients with sub foveal neovascular age related macular degeneration.

Genentech (harbor FVF4579g)

2011 A Phase III randomized, double masked controlled study of XXXXX in subjects with Macular Edema secondary to Central Retinal Vein Occlusion Regeneron (VGFT-OD 0819)

2011 A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of XXXXX in Patients with Diabetic Macular Edema. PAREXEL # 201601 Regeneron (VGFT-OD-1009)

2012 A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and Efficacy of XXXXX (three doses) for the Treatment of active, Non- Infectious Uveitis of the Posterior Segment of the eye Santen Incorporated, (Protocol No. 32-007)

2012 XXXXX versus XXXXX for Proliferative Diabetic RetinopathyS) 2012 A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of XXXXX in Patients with Macular Edema Secondary to Branch Retinal Vein Occlusion –

-

2012 A prospective, randomized, placebo controlled double blind clinical trial to evaluate whether XXXXX 2mg once daily SC, increases the risk of development or progression of Diabetic Retinopathy when administered to HIV-infected with abdominal lipohypertrophy and concomitant diabetes MR 2001

47-500

2013 An Open-Label Study of the Efficacy, Safety, and Tolerability of XXXXX in Patients with Neovascular Age-Related Macular Degeneration -View VGFTe-AMD-1124) Capella

2013 A phase 2, multi-center, randomized, double-masked, placebo-controlled, parallel group study to investigate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of XXXXX in adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). (GSK114 341BAM)

2013 Prospective Case Crossover Study to Assess Whether XXXXX Exposure in Men with Erectile Dysfunction Increases the Risk for the Development of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Bayer

(NAION 12912)

2015 A PHASE 3 RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS ADMINISTRATION OF XXXXX 7

ADMINISTERED IN COMBINATION WITH LUCENTIS COMPARED TO LUCENTIS MONOTHERAPY IN SUBJECTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

2016 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF XXXXX ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE- RELATED MACULAR DEGENERATION. Genentech/Ho

GX29185 “SPECTRI''

2016 A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of XXXXX in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a XXXXX-Sponsored Study. GX30191

2016 A Multicenter, Prospective, Randomized, Phase III, Non-Inferiority Trial of Eyes with Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing XXXXX Every 4 Weeks Versus XXXXX Every 4 Weeks

2016 Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual AcuityDRCR.net Protocol V

2017 A PHASE 2, DOUBLE-MASKED, RANDOMIZED, CONTROLLED, MULTIPLE-DOSE, REGIMEN-RANGING STUDY OF THE EFFICACY AND SAFETY OF INTRAVITREAL XXXXX IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION 2017 Intravitreous XXXXX Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

2017 Phase III Study of the Efficacy and Safety of XXXXX Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age -Related Macular Degeneration. ORBIT

2017 Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered XXXXX15MG Once Daily or 15MG Twice Daily for 12 Months in Patients with Moderate to Severe Non-Proliferative Diabetic Retinopathy 9778-CI-5001

2017 A Randomized, Double Masked, Placebo-Controlled Study Evaluating XXXXX in Subjects with Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration.

University of Virginia Department of Ophthalmology TOGA-01 Phase II/III 2018 XXXXX therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men

(ABVCOVCAR100; M16-100) (TRAVERSE) Study

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2018 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF XXXXX ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT.

(ESPIQVC

2018 A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of XXXXX Followed by Administration of XXXXX Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease

(MSDXXXVAC017; V114 - 017)(PNEU – DAY)

2018 A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of XXXXX Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Alone or in Combination with Sulfonylurea.

(SANPPDDIA337; EFC15337)

2018 A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of XXXXX Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

(SANPPDDIA822; EFC14822)

2018 A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of XXXXX Once Weekly Compared to XXXXX Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin.

(SANPPDDIA829; EFC14829)

2018 A 56-week, Multicenter, Double-blind, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of XXXXX Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Basal Insulin Alone or in Combination with Oral Antidiabetic Drug(s)

(SANPPDDIA893; EFC14893)

2018 A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of XXXXX Administered Subcutaneously to Subjects with Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)

(AKCPPDNAF802; ISIS 703802-CS2)

2019 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of XXXXX in Patients with Diabetic Gastroparesis

(ALLXXXDGPD01; RLM-MD-01)

2019 A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an XXXXX Regimen in the Prevention of RT-PCR- confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

2020 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE- FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND 9

EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS.

2020 A Phase 3, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Efficacy, Safety And Tolerability Of A Clostridium difficile Vaccine In Adults 50 Years Of Age And Older

2021 The CRISIS2 Study: A phase 2, randomized, double blind, placebo-controlled, multi- center study assessing the safety and anti-coronavirus response of suppression of host nucleotide synthesis in out-patient adults with SARS-CoV-2 Protocol Version: Version 5 dated 19 November 2020Protocol ID Number: CCB-CRISIS-02 2021 1450-BJI-205 Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/oral in the Treatment of Patients with Bone or Joint Infection due to Staphylococcus” Debio pharmaceuticals 2021 A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients with Mild to Moderate Pneumonia due to COVID-19GHCovid-2-001

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