Paula M. Mueller, RN, BSN, CCRA

*** *** ****** **** #***, St. Paul, Minnesota 55101

ad3iqo@r.postjobfree.com • 703-***-****

SUMMARY

Ms. Mueller has served as a Registered Nurse and Senior Clinical Research Associate, Study Site Manager, Clinical Nurse Educator, Clinical Trials Manager, Clinical Nurse Manager on two Psychiatric Units and Clinical Research Coordinator on a variety of Clinical Research Projects. Her specialties are in Neuroscience and Psychiatry. She has instructed surgeons in the operating room and physicians on the proper use of the devices and investigational products. She has also worked as a nurse/charge nurse and Clinical Nurse Manager on two Psychiatric units.

Over her career, she has worked with children, adolescents, and adults; served as a resource to her patients, sites, and fellow colleagues; and has been a mentor to new nurses both in the Inpatient Psychiatry, Clinical Nurse Educators, and Clinical Research Associates. PROJECT EXPERIENCE

Phase I, II, III Schizophrenia / Antipsychotic Medication CRA (lead on Phase I) Aug 2005 - Oct 2006 Phase II, III Parkinson’s Disease / Neuroscience CRA (& nurse educator) Sep 2007 - May 2017 Phase II, III Lewy Body Dementia / Neuroscience CRA May 2016 - Dec 2019 Phase III Schizophrenia / Antipsychotic Medication CRA Sep 2005- Feb 2009 Phase III Alzheimer’s Disease / Neuroscience CRA Apr 2006 - May 2007 Phase II Attention Deficit Hyperactivity Disorder (ADHD), Device Jun-2022 – Present Phase II Rare Disease, Prader-Willi Syndrome Jun-2022 - Present EMPLOYMENT HISTORY

PROTRIALS (Los Gatos, CA) Jun 2022 - Present

Senior Clinical Research Associate

• Managed site start-up (site selection, site initiation, and first interim monitoring visits, institutional review board approvals, receipt of study supplies, investigational product and staff training).

• Managing rare disease (Prader-Willi Syndrome) project

• Managing ADHD device project simultaneously with Rare Disease project SYNEOS HEALTH (Morrisville, NC) Jan 2020 - Jun 2020 Senior Clinical Research Associate & Site Manager

• Managed site start-up (site selection, site initiation, and first interim monitoring visits, institutional review board approvals, receipt of study supplies, investigational product and staff training).

• Assisted with revisions of study protocols with cancellation of all in-person site visits due to outbreak of COVID pandemic for highly complex Alzheimer's Disease study to conduct them virtually via zoom.

• Managed 10 sites across US (until furlough due to inability to continue study with global pandemic). PRA HEALTH SCIENCES (now ICON) (Raleigh, NC) Jan 2019 - Nov 2019 Senior Clinical Research Associate & Site Manager

• Managed 10 sites nationwide for a medication study for a non-opioid inpatient adult surgical study for gastrointestinal procedures; assigned to be onsite as a resource for first US subject.

• Served as resource during study for all questions on medications (study and concomitant), lab draws, electrocardiogram timing, post-operative diet orders, progression of diet, and discharge orders.

• Liaised closely with doctors, nurses, study team, sponsor, and other clinical research associates via calls, emails, and monitoring visits to ensure site success with study recruitment and subject safety. WORLDWIDE CLINICAL TRIALS (Research Triangle Park, NC) May 2017 - Dec 2018 Senior Clinical Research Associate & Site Manager

• Managed 12 sites simultaneously across US Northeast for a Phase II Alzheimer's Disease Project.

• Conducted interim and close-out monitoring visits in adherence to the protocol requirements; oversaw Investigational Product (IP) Accountability and IP Return with pharmacists or delegated staff.

• Liaised with site staff, CRO, and pharmaceutical client in all facets of the research process - collecting of data, advising on adverse and serious adverse events, and guiding site staff throughout study. 1

QUINTILES (now IQVIA) (Parsippany, NJ) Jul 2005 - May 2017 Nurse Advisor I, Clinical Nurse Educator (AbbVie, Washington DC Territory) May 2014 - May 2017 Neuroscience Nurse Educator, Global Medical Affairs, Global Pharmaceutical R&D

• Provided education for AbbVie Pharmaceuticals for Duopa (indicated for Parkinson’s disease).

(Duopa had been with Abbott and Solvay Pharmaceuticals and was FDA approved in May 2015.)

• Interacted directly with neurologists and clinic staff on proper use of the medication and pump/device. Advised Endoscopy and Surgical OR staff on surgical component and procedure for the device.

• Trained other Neurology healthcare professionals and support staff on the medication and device. Senior Clinical Research Associate Oct 2007 - Dec 2013

• Provided monitoring visits and site management for a variety of protocols that are complex and/or require knowledge in advanced therapeutic areas.

• Administered protocol and related study training to assigned sites; established regular lines of communication with sites to manage project expectations and issues.

• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations; escalated quality issues to CTL, whenever indicated.

• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.

• Served as a mentor for new clinical staff and may provide assistance to the CTL. Clinical Research Associate Jul 2005 - Oct 2007

• Instructed the investigational site staff in their roles and responsibilities in conducting clinical studies and evaluated site performance and compliance in conducting clinical studies.

• Monitored regulatory status of studies at sites.

• Completed site visit reports and managed all communications with sites. CHILDREN’S NATIONAL MEDICAL CENTER (Washington, DC) Jan 2001 - Apr 2004 Clinical Trials Unit Manager (previously Clinical Manager of 12-bed pediatric psychiatric acute care unit)

• Supervised an eight-member team of nurses, research coordinators, and research assistants.

• Managed site start-up/initiation, interim monitoring, and close-out visits for clinical research studies.

• Planned, scheduled, and implemented day-to-day clinical activities and procedures to ensure efficient workflow, high-quality care and treatment of research subjects.

• Worked closely with Institutional Review Board and other regulatory bodies to ensure compliance.

• Ensured all clinical activities and documentation were in accordance with established research protocol and within acceptable clinical procedure and safety standards adhering to GCP guidelines. EDUCATION

CERTIFICATIONS

• Association of Clinical Research Professionals (ACRP) 2005-2025 Certified Clinical Research Associate (CCRA)

• American Nurses Credentialing Center (ANCC): Board for Psychiatric and Mental Health 1997-2007 Board-Certified Psychiatric and Mental Health Nurse

• Association of Clinical Research Professionals (ACRP) 2002-2006 Certified Clinical Research Coordinator (CCRC)

ADDITIONAL

Licensure

• Registered Nurse (RN), Virginia (Active License #: 000******* issued Jul 2004, expires Dec 2024). In the process of obtaining Minnesota license.

Professional Association Memberships

• Virginia Nurses Association (VNA) – current

• Association of Clinical Research Professionals (ACRP) – current, Exp.

• American Psychiatric Nurses Association (APNA) – past

• District of Columbia Nurses Association (DCNA) – past 1994 The Minnesota State University at Mankato Bachelor of Science in Nursing (BSN) 2014 The George Washington University Master of Public Health (MPH) – started

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Honors

• Excellent Customer Service Provider Awards, Children’s National Medical Center, Washington, DC

• Customer Care Awards at QUINTILES (now IQVIA)

• High Scores (94-100%) on Sponsor Surveys (In Nurse Educator Role)

• Career Spotlight recipient at QUINTILES, featured on the QUINTILES public website (Fall 2015) References Available Upon Request

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Resume of Paula M. Mueller ad3iqo@r.postjobfree.com • 703-***-**** page 2 of 2

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