Clinical Research Manager

Profile

A conscientious, degreed (BS, Biology) and certified (CCRA) Senior Clinical Research Associate with 15 years of experience monitoring and auditing clinical drug and vaccine studies across Phases I-IV as well as a Phase III clinical device study.

Work Experience

IQVIA Biotech Wilmington, NC

(October 2019-Present)

Senior Clinical Research Associate

Monitor Phase I study for Basal Cell Carcinoma and Phase III study for Acute Myeloid Leukemia as well as a Medical Device study for COVID-19 in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Participates in the preparation and execution of Phase I-IV clinical

trials.

Oversaw the progress of clinical investigations by conducting site evaluation, initiation, interim and close out visits to sites.

Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.

Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements.

The Senior CRA may also serve in the Lead CRA role.

DOCS Global Raleigh, NC

(September 2018-October 2019)

Clinical Research Associate

Monitored Phase III studies for Multiple Myeloma as well as a Phase IIIB study for Cardiovascular Disease and an Observational study for Non-myeloid Malignancies. In addition, monitored a Phase II study for Severe Atopic Dermatitis in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Planned, executed and supported clinical site management activities.

Supported the needs of internal and external clients or stakeholders.

Conducted clinical trial site visits including evaluation, initiation, monitoring and close out.

Oversaw and reported on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems.

Built and maintained solid and professional relationships with site staff.

Facilitated subject enrollment incorporating recruitment strategies and action plans at site level.

Maintained site audit/inspection readiness.

Ensured appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks.

Verified electronic case report form data against written and electronic source documentation as per study schema/monitoring plan.

Responded to site queries and escalated issues in accordance with processes and timelines.

Conducted IP accountability and reconciliation.

Facilitated implemented new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting).

Maintained site study supplies.

Contributed to sponsor goals

Promoted operational and scientific excellence

Identified opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.

Sarah Cannon (Contract via Insight Global) Nashville, TN

(April 2018-May 2018)

Protocol Excellent Specialist (Remote)

Built protocol amendments into the Clinical Trial Management System for billing purposes.

PPD Wilmington, NC

(June 2017-March 2018)

Senior Clinical Research Associate

Monitored vaccine studies for a Phase III clinical trial on Dengue Fever and a Phase IIIA clinical trial in Human Rotavirus (HRV) and a Phase IIB clinical trial in Chronic Obstructive Pulmonary Disease (COPD) as well as a Phase I/II clinical trial in Respiratory Syncytial Virus (RSV) in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted the following visit types: Site Initiation, Interim Monitoring Visits and attended Investigator Meetings.

Monitored investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/ clinic notes (source documentation) and AE/SAE reporting.

Assessed investigational product through physical inventory and records review.

Documented observations in reports and letters in a timely manner using approved business writing standards.

Escalated observed deficiencies and issues to clinical management expeditiously, presented solutions and followed all issues through to resolution.

Provided updates on potential trends noted across multiple sites and discussed potential strategies for their management to the Clinical Team Manager (CTM).

Maintained regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues were resolved and that the data was recorded in a timely manner.

Participated in regulatory and ethics submissions and contract and budget discussions with sites.

Conducted monitoring tasks in accordance with the approved monitoring plan.

Initiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.

Managed the essential documents, as required by local regulations and ICH GCP, before as well as during a clinical trial which included collection and translations of key documents.

Performed additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRAs).

Provided trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.

Ensured study systems were updated per agreed study conventions.

Performed QC check of reports generated from CTMS system where required.

Facilitated effective communications between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.

Maintained & completed administrative tasks such as expense reports and timesheets in a timely manner.

PRA Health Sciences Blue Bell, PA

(October 2016-June 2017)

Clinical Research Associate III

Monitored Phase III clinical trials in Pediatric Acute Venous Thromboembolism and Prostate Cancer in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and were compliant with applicable local regulatory requirements and ICH-GCP guidelines.

Conducted Interim Monitoring Visits at investigative sites, instructed site personnel on the proper conduct of clinical trials.

Reviewed and verified accuracy of clinical trials data collected, either onsite or remotely.

Provided regular site status information to team members, trial management, and updated trial management tools.

Completed monitoring activity documents as required by PRA SOPs or other contractual obligations.

Worked closely with other clinical team members to facilitate timely resolution of trial and /or clinical issues.

Escalated site and trial related issues per PRA SOPs, until identified issues were resolved or closed.

Performed essential document site file reconciliation.

Performed source document verification and query resolution.

Assessed IP accountability, dispensation, and compliance at the investigative sites.

Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.

Communicated with investigative sites. Updated applicable tracking systems.

Ensured all required training is completed and documented.

Mentored junior level CRAs and served as a resource for new employees. Assigned additional Clinical Operations tasks.

inVentive Health, Clinical Division Tampa, FL

(May 2016-October 2016)

Senior Site Clinical Research Associate

Monitored Phase II clinical trials in Alzheimer’s and Progressive Supranuclear Palsy as well as an Observational study for Psoriatic Arthritis in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted clinical site monitoring visits which included: Site Initiation and Interim Monitoring Visits across multiple protocols and therapeutic areas.

Ensured studies were conducted according to Good Clinical Practices (GCPs), ICH Guidelines and Standard Operating Procedures (SOPs) as well as the Protocol and Monitoring Plan.

Ensured timely submission of quality data from study sites, including appropriate reporting and follow-up for all safety events by site personnel.

Trained study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Completed and reviewed monitoring visit reports.

Prepared CA and/or EC documentation, ensured submissions and/or notifications were performed as applicable.

Employed good financial management to conserve costs of departmental operation and controlled travel expenses, with guidance from Senior Management as appropriate.

Maintained and completed expense reports as per local and applicable guidelines.

Managed investigator payments as per executed contract obligations.

Negotiated investigator/ hospital agreements with stakeholders.

Participated in and/or presented at departmental and other functional

meetings as needed, including Site Management & Monitoring meetings.

Identified and partnered with other personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs.

Maintained knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities.

Underwent and maintained training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures.

Quintiles’ Transnational Corporation Atlanta, GA

(November 2011-May 2016)

Regional Senior Clinical Research Associate III

Monitored Phase II clinical trials in Diabetes Mellitus Type II and Muscle Weakness and a Phase II/III clinical trial in Attention Deficit/Hyperactivity Disorder as well as Phase III clinical trials in Migraine, Psoriasis, Rheumatoid Arthritis, Diabetes Mellitus Type II, Duchene Muscular Dystrophy, Primary Hyperlipidemia, Schizophrenia, General Anxiety Disorder and Juvenile Primary Fibromyalgia Syndrome. In addition, monitored Phase IV clinical trials in Diabetes Mellitus Type II and Vertebral Fractures in accordance with contracted scope of work and good clinical practice.

Conducted a variety of on-site monitoring visits which include: Site Initiation, Interim as well as Close-Out Visits and attended various Investigator Meetings.

Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing 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 Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.

Managed the progress of assigned studies by tracking regulatory submissions, approvals, recruitment and enrollment, case report form (CRF) completion as well as submission, data query generation and resolution.

Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Acted as a mentor for new clinical staff.

Provided assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.

Pharmatech Oncology, Inc. (Contract via monitorforhire) Conshohocken, PA

(June 2011-July 2011)

Regional Senior Clinical Research Associate

Monitored a Phase III clinical trial in Pancreatic Cancer in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations and Standard Operating Procedures (SOPs).

Conducted a Site Initiation Visit as well as Interim Monitoring Visits.

Performed investigator site file review and reconciliation.

Qualified electronic Case Report Forms (eCRF) using Electronic Data Capture (EDC) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments.

Informed project team members on site activity.

Emory University (Contract via ClinForce) Atlanta, GA

(January 2010-April 2010)

Senior Clinical Research Associate

Audited Phase I clinical trials for Solid Tumors and Lymphomas, Acute Leukemias and a Phase IB clinical trial in Non-Small Cell Lung Cancer, Phase I/II clinical trial in Premalignant Lesions of the Head and Neck as well as Phase II clinical trials in Islet Cell Cancer, Glioblastoma Multiforme and Metastatic Breast Cancer. In addition, audited Phase III clinical trials for Stage III and IV Carcinomas of the Head and Neck and Multiple Myeloma in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted on-site monitoring visits.

Performed investigator site file review and reconciliation.

Verified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports. Assisted site with new study developments.

Informed project team members on site activity.

Chiltern International Austin, TX

(April 2008-November 2008)

Regional Senior Clinical Research Associate

Monitored a Phase III clinical trial in Hyponatremia in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted Interim Monitoring Visits.

Performed investigator site file review and reconciliation.

Qualified electronic Case Report Forms (eCRF) using Electronic Data Capture (EDC) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments.

Informed project team members on site activity.

Covance, Inc. Princeton, NJ

(March 2005-October 2005)

Regional Senior Clinical Research Associate

Monitored a Phase II clinical trial in Renal Cell Carcinoma and a Phase III clinical trial in Hypertension in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted a variety of on-site monitoring visits including: Site Initiation, Interim Monitoring Visits as well as attended an Investigator Meeting.

Performed investigator site file review and reconciliation.

Qualified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments.

Informed project team members on site activity.

Sanofi-Aventis Pharmaceuticals Bridgewater, NJ

(December 2002-February 2005)

Regional Senior Clinical Research Associate

Monitored a Phase II/III clinical trial in Non-Emergent Percutaneous Cardiovascular Intervention and Phase III clinical trials in Acute Maxillary Sinusitis, Osteoporosis, Rhinitis and Venous Thromboembolism as well as a Phase IV clinical trial in Diabetes Mellitus Type II in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted a variety of on-site monitoring visits including: Pre-Study, Initiation, Interim, Co-Monitoring and Study Termination.

Attended various Investigator Meetings as well as presented at an Investigator Meeting.

Assisted sites with completion, submission and collection of regulatory documents.

Performed investigator site file review and reconciliation.

Qualified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Mentored other Clinical Research Associates.

Assisted sites with new study developments.

Informed project team members on site activity.

Covalent Group, Inc. Wayne, PA

(July 2002-December 2002)

Regional Senior Clinical Research Associate

Monitored Phase III clinical trials in Coronary Artery Disease and Hypertension in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted a variety of on-site monitoring visits including: Site Initiation, Interim, Co-Monitoring and Study Termination.

Performed investigator site file review and reconciliation.

Verified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments.

Informed project team members on site activity.

Parexel International RTP, NC

(November 2001-July 2002)

Regional Clinical Research Associate II

Monitored Phase III clinical trials in Coronary Artery Disease (Coated-Stent) and Melanoma in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted a variety of on-site monitoring visits including: Initiation, Interim and Co-Monitoring as well as attended various Investigator Meetings.

Performed investigator site file review and reconciliation.

Qualified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed device and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments.

Informed project team members on site activity.

Quintiles’ Transnational Corporation Atlanta, GA

(October 1999-November 2001)

Clinical Research Associate I

Monitored Phase II clinical trials in Acute Intracerebral Hemorrhage and Opiate Dependence and Phase III clinical trials in Alzheimer's, Diabetes Mellitus Type II, Erectile Dysfunction, Insomnia, Intermittent Claudication, Migraine and Osteoarthritis in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Conducted a variety of on-site monitoring visits including: Site Initiation, Interim, Co-Monitoring and Site Closure as well as attended various Investigator Meetings.

Performed investigator site file review and reconciliation.

Qualified Case Report Forms (CRFs) against source documentation for completeness and accuracy.

Ensured Adverse Event (AE) and Serious Adverse Event (SAE) reporting.

Performed drug and materials accountability.

Completed site monitoring reports and site letters.

Assisted sites with new study developments. Informed project team members on site activity.

Developed monitoring tool for project team.

The United States Playing Card Company Cincinnati, OH

(November 1997-March 1999)

R&D Process Chemist

Provided technical support to manufacturing and quality control in material and paper converting process.

Conducted a variety of tests following Technical Association of the Pulp and Paper Industry (TAPPI) standards on raw stock, laminate, coated, press-ready and printed in accordance with Good Laboratory Practices (GLPs).

Evaluated materials from various suppliers to improve product quality and reduce manufacturing costs.

Assisted in planning, organizing and conducting various paper trials.

Standardized testing procedures increasing accuracy as well as trained personnel on instrumentation and test methods.

Developed new test method which aided in evaluating and resolving customer complaints.

Served on the safety committee helping to ensure laboratory and manufacturing compliance toward Occupational Safety and Health Administration (OSHA) standards.

Kendle Research & Associates Cincinnati, OH

(January 1997-June 1997)

Clinical Research Associate

Interacted daily with investigators, study coordinators and site personnel to qualify and collect medical data necessary for the completion of Case Report Forms (CRFs) for a Phase IIIB/IV Hypertension Study in accordance with protocol requirements, ICH-GCP, FDA guidelines, local regulations as well as Standard Operating Procedures (SOPs).

Trained and used Oracle computer software to help manage study data.

Assisted sites with new study developments.

Informed project team members on site activity.

Worked with other Lead Clinical Research Associates to become familiar with other clinical trials.

Qualifications & Training

Bachelor of Science, Biology (Pre-Med Program) University of Michigan

Bachelor of Science, Chemistry (Junior/Senior Status) University of Cincinnati

May 2019 Recertified Clinical Research Associate

May 2017 Recertified Clinical Research Associate

May 2015 Recertified Clinical Research Associate

June 2014 GCP Barnett accreditation awarded

May 2013 Recertified Clinical Research Associate

June 2012 GCP Barnett accreditation awarded

May 2011 Recertified Clinical Research Associate

July 2010 Training GCP Requirement or Remedy?

April 2010 Device and Drug Clinical Development: Similarities and

Differences Explored

April 2009 Recertified Clinical Research Associate

March 2009 Legal and Regulatory Hot Topics: Part II

December 2008 Legal and Regulatory Hot Topics: Part I

March 2008 Clinical Trial Agreements Educational Program

August 2007 Fraud at Investigators Sites Educational Program

March 2007 Recertified Clinical Research Associate

July 2006 Foundations of a Successful Site Educational Program

March 2005 Certified Clinical Research Associate

September 2004 Detection and Prevention of Clinical Research Fraud and

Misconduct

May 2004 How to Prepare for an FDA Audit Workshop

Therapeutic Area Experience

Allergies 2 years

Phase III Rhinitis

Anti-Infective 2 years

Phase III Acute Maxillary Sinusitis

Cardiovascular 8.5 years

Phase II/ III Non Emergent Percutaneous Cardiovascular Intervention

Phase IIIB/IV Hypertension

Phase III Hypertension

Phase III Coronary Artery Disease

Phase III Coronary Artery Disease (Coated Stent)

Phase III Venous Thromboembolism

Phase III Intermittent Claudication

Phase II Acute Intracerebral Hemorrhage

Phase III Primary Hyperlipidemia

Phase III Hyponatremia

Mental Disorders 4 years

Phase III Schizophrenia

Phase III General Anxiety Disorder

Phase II Opiate Dependence

Central Nervous System 8 years

Phase II/III Attention Deficit/Hyperactivity Disorder

Phase III Migraine

Phase III Duchene Muscular Dystrophy

Phase III Juvenile Primary Fibromyalgia Syndrome

Phase II/III Alzheimer's

Phase III Insomnia

Phase II Progressive Supranuclear Palsy

Dermatology 4 years

Phase II Dermatitis

Phase III Psoriasis

Endocrinology 8 years

Phases II, III and IV Diabetes Mellitus Type II

Oncology 2 years

Monitored:

Phase I Basal Cell Carcinoma

Phase III Acute Myeloid Leukemia

Phase III Prostate Cancer

Phase III Pancreatic Cancer

Phase II Renal Cell Carcinoma

Phase III Melanoma

Phase III Multiple Myeloma

Observational Non-myeloid Malignancies

Audited:

Phase I Solid Tumors and Lymphomas and Acute Leukemia’s

Phase IB Non-Small Cell Lung Cancer

Phase I/II Premalignant Lesions of the Head and Neck

Phase II Islet Cell Cancer, Glioblastoma Multiform and Metastatic Breast Cancer.

Phase III for Stage III and IV Carcinomas of the Head and Neck and Multiple Myeloma

Musculoskeletal 8 years

Phase II Muscle Weakness

Phase III Osteoarthritis

Phase III Rheumatoid Arthritis

Phase III Osteoporosis

Phase IV Vertebral Fractures

Genitourinary 2 years

Phase III Erectile Dysfunction

Vaccines 9 months

Phase III Dengue Fever

Phase IIIA Human Rotavirus (HRV)

Phase IIB Chronic Obstructive Pulmonary Disease (COPD)

Phase I/II Respiratory Syncytial Virus (RSV)

Professional Associations

Association of Clinical Research Professionals

Additional Skills

Computer Proficiencies: MS Word, MS Excel, MS PowerPoint, MS Outlook, EDC, Lotus Notes, Oracle, CTMS, Inntrax

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