Jennifer Boylan
Orlando,Florida
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
24
24
years of professional experience
Work History
Senior Clinical Research Associate
ICON/PRA Health Sciences
05.2016 - 12.2022
- Implemented complete site management including monitoring visits, regulatory assessment, drug supply management to ensure compliance with protocol, GCP, global and local regulations, global and local processes
- Identified problems at sites; resolve issues and escalate as appropriate
- Reviewed and managed data at site; resolved technical and content issues on a continuous basis in order to achieve timely database lock targets
- Facilitated the preparation and collection of site and country level documents during all phases of the trial
- Supported the CSM in the oversight of Country and Site Trial Master Files during all phases of the trial ensure archiving per relevant SOP
- Implement site close-out activities and generate site close-out report.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
Senior Clinical Research Associate
Quintiles
08.2008 - 12.2015
- Performed site initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and establish 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
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and 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.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Contract Clinical Research Associate
Clinical Research Consultants
12.2004 - 07.2008
- Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs, ICH guidelines and Federal regulations
- Review regulatory documents as required and prepare site visit reports
- Budget preparation and negotiation with investigators, collection of regulatory documents, management of source documentation, site instruction, expedient query resolution
- FDA audit preparation
- Approval of regulatory documents package for site initiations
- Performed evaluation, initiation, interim, and site close-out monitoring visits
- Performed Drug Accountability of investigational product including return and disposal of used drug
- Evaluated site capabilities for the performance of Electronic Data Capture
- Trained site personnel in EDC
- Trained study personnel in the implementation of the clinical protocols.
Clinical Research Coordinator
Ocala Neurodiagnostic Center
06.2004 - 12.2006
- Independent management of study staff, budgets, and liaison to Institutional Review Board, hospitals, physicians, sponsors, and contract research organizations
- Coordination of device and pharmaceutical phase I-IV clinical trials for inpatient and outpatient studies
- Adhere to and implement study protocol with safety, integrity, and efficiency while applying knowledge of good clinical practices
- Develop and execute recruitment procedures for potential participants; manage enrollment of the trial from screening to study completion
- Evaluate clinical data ensuring compliance with protocol and overall clinical objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
Adjunct Instructor
Webster College
06.2004 - 04.2005
- Planed and implemented educational activities designed to assist students in achieving their educational goals
- Created objectives and outlines for courses of study and assist in the development of curriculum
- Prepared and delivered high quality instruction enhancing the classroom environment by acting as a facilitator to promote student leadership and create a positive learning opportunity.
- Developed semester outlines and instructional plans for each class session to comply with stated course objectives.
Substitute Teacher
Orange County Public School District
11.2001 - 05.2004
- Followed and/or adapted lesson plans provided by the classroom teacher in an appropriate manner
- Used appropriate teaching strategies, methods of presentation and techniques to motivate students in order to meet lesson plan requirements
- Maintained and/or developed as required class rules, procedures, routines and consequences, promoting a safe, orderly learning environment.
Flight Attendant
Delta Air Lines
11.1999 - 11.2002
- Provided high quality customer service and ensured a safe environment for crew and passengers
- Have knowledge of and comply with all Federal Aviation regulations and guidelines
- Represented Delta in a positive manner and maintain a friendly, positive demeanor.
- Increased customer loyalty through personalized interactions, promptly attending to concerns, and resolving issues professionally.
- Participated in regular training sessions to stay current on industry trends, evolving company policies, safety procedures, and customer service strategies.
Speech-Language Therapist
Okaloosa County Public School District
08.1998 - 06.1999
- Evaluated and improved children with Speech, Processing, and Language Disorders
- Strengthened children with Cerebral Palsy, Autism, and Developmentally Delayed
- Developed and maintained individual reports that included evaluation, diagnosis, treatment plan, procedures, and methods
- Created and implemented individual and group therapy programs by setting long-term and short-term goals and recommendations for treatment and follow-up.
- Promoted early intervention services within the community, raising awareness about the importance of addressing potential speech-language issues in young children.
Education
Master of Science in Health Service Administration -
University of Central Florida
Orlando, Florida05.2004
Bachelor of Science in Speech-Language Pathology and Audiology -
Florida State University
Tallahassee, Florida05.1998
Skills
- Completing Regulatory Documents
- Site Management
- Report Writing
- Action Planning
- Electronic data capture systems
- Clinical trial management
- ICH-GCP guidelines
Clinical Trials
- A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of XXX Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI.
- A Prospective, Controlled, Randomized, Multicenter Study Comparing NeuroFlo Treatment in Ischemic Stroke Less Than 8 Hours From Onset of Symptoms to Standard Medical Management.
- A Double-Blind, Placebo-Controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients with Parkinson's Disease Suffering From Treatment-Associated Dyskinesia.
- An Open-Label, Multicenter, Multinational, Phase III Follow-Up Study to Investigate the Long-Term Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients with Parkinson's Disease Suffering From Treatment-Associated Dyskinesia.
- A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XXX Administered by Continuous IV Infusion to Patients with Acute Cerebral Infarction and Hyperglycemia.
- Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization Management and Avoidance. Randomized, Multinational, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20 mg for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients with Clustering Risk Factors.
- A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod in Subjects Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke.
- A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of XXX Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis.
- Two Treatment Approaches for Human Regular U-500 Insulin in Subjects with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Therapy with or without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial.
- Two Approaches to Escalate Lispro Therapy in Patients with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone.
- A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of XXX for Duchenne Muscular Dystrophy.
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of XXX in Patients with Episodic Migraine.
- A Phase 2b, Randomized, Double-Blind, Active-Conparator-Controlled, Dose Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of XXX Given in Combination with Doravirine and Lamivudinein HIV-1 Infected Treatment Naive Adults.
- A Phase 3, Randomized, Double-blind, Placebo-controlled, 12-month Study to Evaluate the Efficacy and Safety of XXX in Adult Participants with Chronic Cough.
- A Phase 3b Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of XXX in Women with Chronic Cough and Stress Urinary Incontinence.
- A Phase 3, Multicenter, Randomized, Double-blind, active Comparator-controlled Study to Evaluate the Safety, tolerability, and Immunogenicity of XXX Followed by Administration of PNEUMOVAX 23 Six Months Later to Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease.
- A Double-Blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate versus Phenytoin in Subjects with Seizures Indicative of New Onset Epilepsy In-Service Program.
- A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of XXX in Early Parkinson's Disease Patients.
- Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacologic Effect of XXX in Patients with Psoriasis.
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of XXX in Patients with Moderate-to-Severe Plaque Psoriasis.
- Pharmacokinetic of XXX following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients with Moderate-to-Severe Plaque Psoriasis.
- XXX Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Reemergence in Major Depressive Disorder.
- Long-Term, Open-Label, Safety Study of XXX in Pediatric Patients with Attention Deficit/Hyperactivity Disorder.
- A Randomized, Double-Blind, Active Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of XXX in Patients with Moderately to Severely Active Rheumatoid Arthritis, Who have had Limited to No Treatment with Disease - Modifying Antirheumatic Drugs.
- A Pharmacokinetic Study Using Lopinavir and Rifabutin Concentrations Administered to Patients Co-Infected with HIV and Tuberculosis.
- A Multicenter, Randomized, Double-Blinded Study to Determine the Efficacy and Safety of the Addition of XXX versus Dose Titration from 30 mg to 45mg of XXX in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination
- XXX and 30mg of XXX Therapy.
- A Randomized, Double Blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Multiple XXX Dose Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persisten Non-Cancer Pain.
- A Randomized, Double Blind, Placebo Controlled, Multi-center Phase IIb Study to Evaluate the Efficacy and Safety of Multiple XXX Dose Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Patients.
- A Phase III, Randomized Double-Blind, Placebo-Controlled Multicenter Retreatment Study of XXX in Patients with Active in Patients with Active Chron's Disease and Prior Treatment Response to XXX.
- A Randomized, Controlled, Partially Blinded Phase IIb Dose-Finding Trial of XXX, in HIV-1 Infected Subjects with Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and with at Least Three Primary PI Mutations.
- A Phase III, Multi-Center, Open-Label, 12-Week, Follow-Up Safety and Efficacy Study of Serostim (mammalian cell-dervied recombinant human growth hormone, r-hGH) in Subjects with Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS).
- A Phase III Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy of Serostim in the Treatment and Maintenance of Human Immunodeficiency Virus-Associated Adispose Redistribution Syndrome (HARS).
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Efficacy and Safety of XXX in Subjects with Mild to Moderate Alzheimer's Disease.
- Long-Term Safety and Efficacy of Open-Label XXX, 80 mg b.i.d. in the Treatment of Probable Alzheimer's Disease: An 18-Month Follow-Up After Completion of Study XXX.
- A 6-Month Safety Follow-Up Study of Select Patients Previously Enrolled and Randomized to XXX in Studies MKC-231/A02 or MKC-231/A04.
- A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir and XXX Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide Once-Daily
Timeline
Senior Clinical Research Associate
ICON/PRA Health Sciences
05.2016 - 12.2022
Senior Clinical Research Associate
Quintiles
08.2008 - 12.2015
Contract Clinical Research Associate
Clinical Research Consultants
12.2004 - 07.2008
Clinical Research Coordinator
Ocala Neurodiagnostic Center
06.2004 - 12.2006
Adjunct Instructor
Webster College
06.2004 - 04.2005
Substitute Teacher
Orange County Public School District
11.2001 - 05.2004
Flight Attendant
Delta Air Lines
11.1999 - 11.2002
Speech-Language Therapist
Okaloosa County Public School District
08.1998 - 06.1999
Master of Science in Health Service Administration -
University of Central Florida
Bachelor of Science in Speech-Language Pathology and Audiology -
Florida State University
Similar Profiles
Richard SchulzRichard Schulz
Manager of Global Regulatory Affairs at ICON, PRA Health SciencesManager of Global Regulatory Affairs at ICON, PRA Health Sciences
Kathryn HamKathryn Ham
Project Analyst 1 at ICONProject Analyst 1 at ICON
Carmen OnCarmen On
Senior Project Manager at Syneos HealthSenior Project Manager at Syneos Health