Clinical Research Associate

Susan Nelson

San Marcos, CA

Mobile: 760-***-****

Email: **********@*****.***

EDUCATION: University of San Diego School of Nursing Clinical Trials Design and Management certification 1999 Missouri State University

Bachelor of Science in Psychology

Minor in Criminal Justice

PROFESSIONAL EXPERIENCE:

Bayer HealthCare, New Jersey (remote)

Country Lead Monitor (CLM) June 2015 - present

PRA Health Sciences on assignment with Bayer HealthCare Inc. CLM July 2015 - July 2016

Belcan - on contract with Bayer HealthCare Pharmaceuticals, Inc. CLM Consultant May 2014 - June 2015

CLM: US monitoring team lead for complex phase II/III global studies. Responsible for all aspects of clinical trial activities, CRA oversight, and study progress from feasibility through study archiving.

• Served as primary US liaison for the global core study team, ensuring timely delivery of country-specific trial milestones and maintaining high quality data.

• Directed start-up activities, including ethics and regulatory submissions, ensuring compliant and timely site activation.

• Tracked country-level study milestones, implemented risk mitigation strategies, while maintaining alignment with global timelines.

• Developed and executed strategic plans for enrollment, retention, and site engagement.

• Led audit/inspection readiness activities, resulting in successful outcomes during regulatory evaluations.

• US study budget planning and forecasting, including quarterly variance analyses in collaboration with the global study team.

• Develop and update core country study documents.

• Evaluated CRA training needs and coordinated targeted training to ensure protocol compliance and operational excellence.

• Oversee Trial Master File (TMF) quality and completeness per ICH GCP, SOPs, and regulatory requirements to ensure inspection readiness.

Belcan - on contract with Bayer HealthCare Pharmaceuticals, Inc., Senior Clinical Research Associate Consultant June 2013 - May 2014 Senior CRA: Responsible for all aspects of site management and monitoring activities for assigned Phase II-IV global, complex studies from site selection to study archive.

• Ensured PI/staff compliance with protocol, study procedures, and regulatory requirements.

• Managed site activities and monitored site data to ensure patient safety and quality data.

• Identified potential site issues and developed Corrective Action/Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution.

• Trained and supervised Investigator site staff for trial duration.

• Managed site enrollment progress and implemented site-specific recruitment plans as needed.

• Key contributor in the preparation of site audits and regulatory inspections.

• Ensured essential documents are accurate and filed promptly in the ISF.

• Mentored new hires and conducted various co-monitoring visits as needed. PHARMANET-I3 STRATEGIC RESOURCING (acquired Kforce) On assignment at Pfizer:

April 2012 to April 2013 - Pharmanet-i3 Strategic Resourcing March 2006 to April 2012 - Kforce Clinical Research Clinical Research Associate (CRA)

• Performed Site Selection, Site Initiation, Routine Monitoring, and Site Closure visits.

• Ensured investigative sites are compliant with the protocol, FDA regulations, ICH/GCP guidelines, and company standard operating procedures.

• Managed assigned investigational study sites and performed on-site quality reviews of Case Report Form data.

• Review Informed Consent Forms for accuracy and regulatory compliance, ensure proper administration of Informed Consent, and report any execution issues.

• Performed investigational product accountability and maintained adequate study supplies.

• Worked closely with the data management team, oversaw data compliance, and identified trends and issues.

• Managed site master file contents for completeness and up-to-date information, including IRB-related correspondence and required continuing reviews.

• Identified and selected Investigators for clinical trials, provided feedback for site successes and non-performing sites, and facilitated improvement plans.

• Oversaw and evaluated site-specific enrollment plans and shared best practices.

• Facilitated the IIP and study start-up process as needed.

• Provided support and timely follow-up for any audit and quality assurance activities.

• Completed trip reports, letters, query resolution, and expenses within agreed timelines.

• Proven leadership skills by participating in a CRA Mentoring program to provide additional support to new team members and streamline best practices. PAREXEL INTERNATIONAL, San Diego, CA

August 1999 – May 2005, held the following positions Lead Regional Clinical Research Associate - home-based in San Diego, CA October 2003 – May 2005

• Lead Clinical Research Associate (CRA) for a Phase III glabellar frown line study.

• Lead CRA for a Phase III International psoriatic arthritis clinical trial with 20 centers in the United States and four in Canada.

• Led a 15-member team of CRAs and clinical staff in managing their sites, resolving site issues, and meeting project goals from study start through the end of enrollment, including a data lock.

• Facilitated communication between the Sponsor and CRAs to ensure CRAs were sufficiently trained, current with project expectations, and informed of study deliverables and milestones.

• Accountable for communications between the medical monitor, Sponsor, and site monitors for medical questions regarding eligibility, concomitant medications, and protocol exemptions.

• Analyzed project data and budgets by collecting study metrics monthly to increase productivity and reduce overall study costs.

• Led the clinical team to achieve project objectives as agreed upon with clients. Senior Regional Clinical Research Associate - home-based in San Diego, CA February 2003 – October 2003

• Regional Coordinator for a large, Phase III international ovarian cancer trial. Responsibilities included main contact for the Latin American team, preparation of study materials/tools, report review, clinical liaison for Data Management, and oversight of Central Files.

• Trained and mentored newly assigned CRAs and clinical assistants on study-specific monitoring responsibilities and expectations.

• Managed client communication, assessment of site assignments, and developed study-specific standard forms and tools.

• Assisted in managing study vendors, including Central Laboratory, Interactive Voice Response System, ECG, and Institutional Review Board.

• Participated in and contributed to a project bid, including representing clinical by presenting at a client sales meeting.

Clinical Research Associate I & II- In-house

August 1999 – March 2003

• Monitored Phases III-IV clinical trials, including Pre-study, Initiation, Interim, and Closeout visits.

• Developed relationships with clinical investigators and other site personnel to manage clinical trial conduct and ensure quality data successfully.

• Performed quality control review of clinical data and on-site examination of regulatory documents to ensure adherence to multiple protocols, good clinical practices, FDA Regulations, and ICH guidelines.

• Prepared monitoring visit reports emphasizing Serious Adverse Event reporting, protocol violations, regulatory file deficiencies, and study drug accountability findings.

• Maintained central filing systems and conducted internal file audits. THERAPEUTIC

EXPERIENCE:

• Vasomotor symptoms in post-menopausal women

• Endometriosis and uterine fibroids

• Acute bacterial skin and skin structure infections

• Diabetic peripheral neuropathy, Insomnia, Fibromyalgia, Hypercholesterolemia, schizophrenia, bipolar, COPD, OAB- Phases II-IV

• Oncology- breast, small cell lung, ovarian cancer- Phases III & IV

• Dermatology- psoriatic arthritis- Phase II, psoriasis, glabellar frown lines- Phase III

• Obstetrics/Gynecology- Infertility- Phase III

• Alzheimer’s

COMPUTER

SKILLS:

• Electronic Data Capture systems (RAVE, Medidata, OC-RDC)

• CTMS – Veeva

• Outlook, PowerPoint, WebEx

• Microsoft Word, Excel, Adobe Acrobat

AWARD:

• Award of Excellence in recognition of outstanding support of Bayer Clinical Trials, 2018

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