Clinical Research Trials

Leslie D. Campbell

Summary

Certified Clinical Research professional/Licensed Practical Nurse with 17+ years’ experience in Healthcare and demonstrated expertise in study execution and management, site and staff oversight, quality review and assurance, study budget/timeline adherence, and direct line management experience.

Vast experience in Multispecialty clinical trials, including but not limited to immunology, rheumatology, rare disease/genetherapy, infectious disease, pulmonology, cardiology, dermatology, gastroenterology, surgical, orthopedic, oncology with NCI connections on breast cancer and colon cancer, and women’s health, across all phases of clinical trials.

Employment

AUG 2023 – June 2024 Advanced Clinical

Chicago, IL

Clinical Trial Manager (CTM)

Manage external vendors and contract research organizations

Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual

Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents

Assist with protocol development and study report completion

Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols

Provide guidance, direction, and management to CRAs

Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities

Coordinate study supplies

Negotiate contracts with vendors of clinical trial services

Review Informed Consent Forms, CRFs, and study related materials

Plan and participate in investigator meetings

Assist and support data query process

Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines

Ensures trial master file is current and maintained

AUG 2021 – 2023 Selecta Biosciences, Inc.

Watertown/Boston, MA (Remote)

Manager, Clinical Operations

Ensured all aspects of company projects and clinical programs are successfully managed as per protocol timelines and budget.

Oversaw daily operations and progress related to the conduct and management of all individual clinical trials and other programs/projects being conducted under the company’s ownership or directive.

Oversight of all study related procedures, processes, data collection and documentation, at both the clinical site and CRO levels.

Liaised directly with Clinical Research Organization (CRO), all other pertinent vendors or companies, and the clinical research sites, to ensure effective and productive rapport and communication is built and then maintained.

Provided educational and motivational support to clinical sites regarding all protocol specifications, ethical requirements, and industry standards.

Conducted regular in-depth reviews and quality checks for all study related documentation, (e.g. EDC, data listings, AE/SAE listings, Monitoring Visit Reports, CRFs, etc.), to ensure accurate documentation of clinical data.

Oversight of Quality Issues related to a clinical program or trial, Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA), regulatory authority reporting, and resolution of issues.

Conducted routine QC and analysis on all Protocol Deviations, AEs, SAEs, Adverse Events of Special Interest (AESIs) to determine accurate categorization and documentation.

Worked closely with Data Management to conduct QCs and in-depth reviews of the multiple data sets, trial results (table/listing/figures) and listings.

Communicated updates and other pertinent details relating to the clinical trial or other projects, to executive leadership

Reviewed Trial Master Files(TMF) to confirm accuracy and completeness of study documents.

Scheduled and conducted routine and/or for-cause study specific onsite visits/audits at clinical sites, to review and ensure accuracy for all data collected.

Assisted CRO and other vendors in the training and/or retraining of pertinent site/study staff on study processes and/or study manuals.

Created, updated and approved all new and/or existing company SOPs related to Clinical Operations.

Active member of the company’s Culture Ambassador Team, to enhance corporate culture and improving employee satisfaction

Direct relation with NIH for phase la studies and even NIH Les studies in gene therapy.

MAY 2019 - 2021 Synexus/Accelerated Enrollment Solutions/PPD Pharma

Unknown, AZ – Headquarters have since moved to Wilmington NC (Remote)

Global Training Manager

Created, led, and managed all training needs and sessions for all clinical staff globally.

Provided educational support and training for all new hires within the company on a global basis.

Created all training materials via multiple platforms (i.e., excel, PowerPoint, Microsoft Teams, etc.) in preparation for all trainings or educational sessions that are needed on all levels (i.e., study specific training, new/updated processes, SOPs, role specific trainings, etc.)

Heavy involvement in multiple departments and projects to provide insight and/or experience related feedback to include, but not limited to, Quality Assurance, Clinical Systems Informatics, Clinical Trial Management, Portfolio Directors, Territory Directors/Managers, Directors of Sites, Screener Council, etc.

Assisted in the creation, updates, and merges of company SOPs within our SOP Harmonization Project.

Hosted recurring meetings with lead members of Operations (US) and Global Operations to update both departments on all training efforts, process changes, and current goals or focal points.

Daily involvement in the recruitment strategies for all studies, including the creation and amendments for all screener questions to pinpoint qualified subjects versus non-qualified

MAR 2009 – APR 2017 IACT Health, inc.

Columbus, GA

Regional Clinical Research Program Manager

Management of all day-to-day operations for 8+ separate multispecialty and specialty clinical research offices across Southeast.Provided educational support and training for all new hires within the company on a global basis.

Responsible for the morale, welfare, onboarding, training, scheduling, time sheets and professional development for 40+ clinical research coordinators, nurse practitioners, physicians, patient outreach coordinators and other research professionals

Heavy involvement in multiple departments and projects to provide insight and/or experience related feedback to include, but not limited to, Quality Assurance, Clinical Systems Informatics, Clinical Trial Management, Portfolio Directors, Territory Directors/Managers, Directors of Sites, Screener Council, etc.

Responsible for final decision making within the feasibility process regarding vendor relationships and clinical trial selection and onboarding.

Daily involvement in the recruitment strategies for all studies, including the creation and amendments for all screener questions to pinpoint qualified subjects versus non-qualified.

Responsible for full oversight of data quality for 8 separate multispecialty and specialty clinical research offices across Georgia.

Responsible for directing staff in root cause analysis for all deviations noted as well as the accurate and thorough completion of corrective and preventative action plans (CAPA)

Responsible for initial and ongoing training of all clinical staff and hospital staff in accordance with ICH/GCP guidelines and industry standards and best practices.

Helped achieved overall company goal of a Major Error rate of less than 0.5% due to concrete training of staff, adequate follow through of performance improvement plans and thorough management of data collection.

Designed, standardized and implemented a program of instruction for all inpatient clinical trials consistent with Good Clinical Practices (GCP) and FDA rules and regulations.

Served as Vice Chair for ACRP Professional Development Committee

Facilitated FDA and GCP compliance by providing oversight over all trials as a member of the Quality Assurance and Compliance Committee.

Education

2003 – 2005 Chattahoochee Valley Community College Phenix City, AL

Nursing

Professional Organizations

2009 - 2014 ACRP – Vice Chair

Licensure/Certification

2005 - Present Licensed Practical Nurse

2012 – Present CCRC

Therapeutic Areas of Expertise

Clinical Research (17+) Years of Experience

Auditing (10+) Years of Experience

Clinical Operations (15+) Years of Experience

Therapeutic Area

Controlled Substances

Cardiology/Vascular Diseases

Hypertension

DVT

Thrombosis

Dermatology

Devices

Endocrinology

Diabetes

Family Medicine

Gastroenterology

Genetic Disease

Healthy Volunteers

Hepatology (Liver, Pancreatic, Gall Bladder)

Immunology

Infectious Diseases/Virology

Musculoskeletal

Nephrology

Neurology

Nutrition and Weight Loss

Obstetrics/Gynecology (Women’s Health)

Oncology

Ophthalmology

Orthopedics/Orthopedic Surgery

Otolaryngology (Ear, Nose, Throat)

Pain

Pediatrics/Neonatology

Pharmacology/Toxicology

Psychiatry/Psychology

Pulmonary/Respiratory Diseases

Rheumatology

Sleep

Trauma (Emergency, Injury, Surgery)

Urology

Vaccines

Phase I trials

Phase II trials

Phase III trials

Post Marketing/Phase IV trials

Key Skills

Computer

Microsoft Office

Teams

Outlook

Microsoft Edge

Oracle

Medidata

Rave

Other

Veeva Vault

Endpoint (IRT)

SharePoint

Awards

2011, 2014, 2015 Excellence in Study Execution IACT Health

2013 LIVE IT Award IACT Health

Languages

English, fluent

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