Years of experience in clinical research
PATRICIA HENDERSON
Apex,NC
Summary
Creative director of clinical operation and project and trial management with over 20 years of experience in local and global CRO and pharmaceutical industry, a strong background in site start-up, site activation, phase I, BA/BE, phase II-IV. Site development, Site networking. Expert in planning, execution, organizing, and managing resources to successfully deliver the highest quality completed projects while managing and honoring set constraints management with CROs/clinical vendors and vendor and site audits. Authored SOPs, work in business development, site selection, website design, and developed working relationships with Sponsors and Key Opinion Leaders. Coordinating and implementing research and administrative strategies essential to the successful management of Phase I-IV clinical research trials, site and study management, program and project management for a full-service clinical trial management/global CRO. Supported each clinical team in the creation of a study plan for both timelines and budget with documentation of assumptions/expectations within Microsoft Project. Effectively communicated project status to project stakeholders documenting within Trial Master File (TMF) system Managed Medical Device phase I- IV clinical trials local and global sites sites. Specialize in Site Assessment - start-up, contract, and budget negotiation, Standard Operating Procedures, identify possible risk areas and implement solutions, audit site SOP and data. Background includes trials in the following areas: Neurology, Ophthalmology, Urology, Oncology, Dermatology, CNS, Medical Device, Generic Drug, BA/BE Phase I, Women’s Health and Healthy Volunteer Trials, Nephrology, Well versed in FDA/ICH, IRB/EC Submissions, GCP, 21 CRF part 11, CLIA, OSHA and HIPPA regulations. Authored investigator Initiated trial (ERP) start to finish. Multi-tasking Consultant well-known for successfully taking projects from beginning stages to completion. Polished and professional offering proficiency in clinical research. Commended for consistently meeting new technical challenges and finding solutions to satisfy customer needs. Hardworking Consultant gifted at turning prospects into clients and delivering exceptional presentations. Engaging, personable and focused on delivering exemplary customer service. Outstanding motivator with adaptable communication style and success in collaborating across organizational levels.
Overview
20
20
Work History
Consultant
Care Access Research
Remote, North Carolina
10.2021 - Current
- Responsible for establishing community-based partnerships that would benefit from clinical trial
- Create new opportunities for patients to learn and enroll in current running clinical trials
- Identify, establish, and manage partner relationships
- Set up and organize DCT sites for smooth hand off to site study team
- Research locations for future research sites
- Lead activities for clinical studies
- Help Identify areas that have high density of patients that could benefit from clinical trials
- Identify Physicians that may want to work with Care Access, form relationship and monitor
- Responsible for overall sites performances
- Responsible for site and personnel management
- Site profitability and successful study conduct
- Key point of contact for staff, study subjects, CRO’s and sponsors
- Training
- Tracked costs and expenses to compare with original budget and identify failure points.
- Developed service plans in consultation with clients, and performed follow-ups assessing quantity and quality of services.
- Authored detailed work plans to meet business priorities and deadlines.
- Collaborated with teams to define, strategize and implement marketing and web strategies
- Delivered outstanding service to clients to maintain and extend relationship for future business opportunities
- Onboarded and managed new client accounts to boost retention rates
Clinical Research Manager
North Carolina Nephrology
Raleigh, NC
01.2020 - 04.2022
- Responsible for setting overall direction, strategy, and performance standards for Clinical Research activities, including planning, execution, budgets, audits, and monitoring, day to day operations
- Lead and mentored clinical team, for Phase 1- IV Drug and medical device trials
- Maintaining appropriate resources to meet contractual obligations while ensuring adherence to quality management practices
- Provided strategic direction/project management ensuring that organization and conduct of regulatory and non-regulatory clinical programs were following policies and procedures
- Wrote and implemented clinical research Standard Operating Procedures’
- Created new lab
- Expanded current research department from one office to three to include medical device studies
- Created training programs for Staff for CRC positions and Physicians’ wanting to become Principal Investigator
- POC for Sponsors, Business Development and Vendor selection
- Over personnel, to include interview, hiring, training, study assignments and schedules
- Wrote ERP pilot clinical trial
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Maintained compliance with protocols covering patient care and clinical trial operations
- Increased revenue by 25 %.
Director of Clinical Research Operations (Contracted Consultant)
Azidus, Inc
Green Bay, WI
07.2016 - 12.2017
- Responsible for day-to-day operations and oversight, strategy, and performance standards for Clinical Research activities, including planning, execution, budgets, audits, and monitoring
- Put together, led and mentored clinical team, for Phase I, 100-bed generic drug clinic, medical device, maintaining appropriate resources to meet contractual obligations while ensuring adherence to quality management practices
- Provided strategic direction/project management ensuring that organization and conduct of regulatory and non-regulatory clinical programs were in compliance with policies and procedures
- Built and maintained contact and relationships with Key Opinion Leaders, Investigators, and clinical sites
- Provided updates to Clinical Management and others on progress of studies
- Contributed to identification and evaluation of new clinical sites and external service providers
- Expert in planning, execution, organizing, and managing resources to successfully deliver highest quality completed projects while managing and honoring set constraints management with CROs/clinical vendors and vendor and site audits
- Oversaw and motivated adherence of study teams to operational best practices
- Supported each clinical team in creation of study plan for both timelines and budget with documentation of assumptions/expectations within Microsoft Project.
- Thought operationally and displayed communication and leadership skills to follow through on development plans.
- Implemented broad-scale organization change and transformed research-based functions.
- Drove operational improvements which resulted in savings and improved profit margins
Director of Clinical Research (Contracted Consultant)
AXIS Clinicals Inc
Dilworth, MN
04.2015 - 07.2016
- Recruited and audited 17 sites and 3 SMO's
- Led company’s initiative to build Patient Clinical Trial Full Service CRO Phases l- IV in USA
- Hired, coordinated, and trained staff needed to create appropriate team
- Authored SOPs, work in business development, site selection, website design, and developed working relationships with Sponsors and Key Opinion Leaders
- Identified and qualified research sites throughout U.S
- Develop working relationship with CEO, PI, and staff
- Built and maintained contact and relationships with Key Opinion Leaders, Investigators, and clinical sites
- Contributed to identification and evaluation of new clinical sites and external service providers
- Collaborated with Outsourcing Manager on relationship management with CROs/clinical vendors
- Organized and participated in committee to perform all document and SOP review and revisions
- Set timelines, monitored all trial activities within Microsoft Project
- Ophthalmology, Dermatology, Neurology, Medical Device and Oncology therapeutic areas
- Collaborated with legal, improved legal review of clinical operations and enhanced contract administrator function.
- Thought operationally and displayed communication and leadership skills to follow through on development plans.
- Managed team of employees, overseeing hiring, training and professional growth of employees
Director of Clinical Operations, Consultant
Hill-Top Research, Inc
St. Petersburg, FL
12.2012 - 11.2013
- Planned, executed, and finalized projects within constraints of delivering on time, within budget, and within scope objectives, including acquiring resources and coordinating efforts of team members to deliver projects according to plan within Microsoft Project
- Identified, effectively communicated, and resolved project issues and risks
- Developed risk mitigation plans
- Effectively communicated project status to project stakeholders documenting within Trial Master File (TMF) system
- Coached, mentored, and motivated team members, influencing them to take positive action and have accountability for assigned work
- Directed project portfolios ranging from $5M to $200M
- Implemented stakeholder requirements for database design and validation
- Served as In-house monitor for trials
- Organized and participated in committee to perform document and SOP review and revisions
- Point of contact for all vendors and Sponsors
- Negotiated, reviewed and signed all contract
- Audited sites and vendors
- Strong in Ophthalmic and Dermatology therapeutic protocols, Medical Device.
- Created detailed roadmaps of action items and project goals and generated reports to inform budgeting and planning.
- Improved client sales by automating system e-commerce feature.
- Developed strategic component development plans to support future projects.
- Saved considerable costs by renegotiating outsourcing contracts.
- Tracked costs and expenses to compare with original budget and identify failure points.
- Improved performance, hiring practices and management systems to facilitate success of client's organization
- Established and maintained contacts at various management levels regarding clinical operations department and specific projects
- Delivered outstanding service to clients to maintain and extend relationship for future business opportunities
Director of Clinical Operations/ Business Development (Contracted Consultant)
Discovery Medical Research
Miami, FL
07.2011 - 12.2012
- Successfully created clinical research site from ground up to develop and direct new clinical research site
- Served as a key point of contact for all sponsors & vendors as Project Manager and COO
- Budgeted and contracted development and negotiations
- Responsible for site management and all clinical research activities from feasibility to close out and for assigned projects performed at site conform to GCP standards
- Ensured regulatory submissions were timely and all documents were complete and current
- Managed and coordinated efforts of cross-functional project teams to support milestone achievements
- Managed study issues/obstacles and ensure consistent use of study tools and training
- Performed extensive review of prospective projects, gathering details utilizing pricing project services.
- Evaluated current service needs and product satisfaction levels with established customers to improve offerings.
- Developed short-term and long-term sales objectives and strategic plans to meet market needs.
- Planned and managed adherence to project budget and contracts and assisted in identification and development of scope change documents
Site Manager/CRA, Site manager
Medical Research South
Charleston, SC
12.2010 - 06.2011
- During transfer of $10 million company ownership; trained new CEO and CFO on how to manage clinical research site successfully
- Implementation of new incentives for staff that helped boost morale, increased productivity by 27%, and created positive workplace environment
- Responsible for management of site, staff and all clinical research activities
- Ensured regulatory submissions and documents were complete and current
- Performed study-related procedures, including but not limited to ICF process, obtaining medical histories, phlebotomy processing/sending off samples, study specific procedures
- Performed clinical assessment scales for all studies
- Mentored staff on Ophthalmic, Women’s Health, Dermatology, Oncology, Pulmonary, Medical Device protocols and trial management
- Created and maintained database and records filing system to document data on specimen collection, processing and storage.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Delegated assignments based on plans, project needs and knowledge of individual team members.
- Trained managers of each department in safety protocols and procedures
- Managed site development with assistance from civil engineers and complied with city and county ordinances
Practice Manager/Project Manager (Contracted Consultant)
Diversified Research, Inc
Durham, NC
11.2009 - 11.2010
- Worked with owner to re-establish failing medical and research practice in conjunction with Suboxone medical treatment clinic
- Project Manager for all trials that included business development, patient recruitment, trial execution, data entry, staffing, and all day-to-day trial activities
- Responsible for staff - scheduling, performance reviews, promotions, training, and mentoring
- Ensured site readiness for inspections and audits and that all trials are in compliance with trial protocols, company SOPs, GCP, and local regulatory guidelines
- As Practice Manager, worked closely with physician to make sure all patients met criteria needed to participate in Suboxone programs and to ensure patient satisfaction.
- Developed close working relationships with front office and back office staff.
- Provided outstanding support to entire staff which helped improve process flow and boosted efficiency.
- Boosted staff morale by offering constructive feedback and specific direction.
- Assessed processes and procedures, complying with OSHA and HIPAA regulations.
- Managed team all departments, 5 employees front office, 6 clinical, 3 lab, 3 physicians.
Director of Clinical Research
Guilford Neurologic Associates
Greensboro, NC
05.2007 - 10.2009
- Managed contracting process including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, and Amendments
- Conducted in-house monitoring for phase II-III stroke trials
- Generated revenue of $500k within first six months after opening of new research department.
- Responsible for month-end and year-end reports, monthly meetings for stockholders, and Board of Directors meetings
- Developed all trial documents, review protocols, and regulatory documentation, and negotiated contracts and budgets
- Wrote and implemented new SOPs
- Trained staff and MDs in GCP/ICH regulations
- Project Manager for Phase II-IV trials managed all aspects of clinical trials from site identification, evaluations, protocol selection, staffing, and PI assignment
- Responsible for patient recruitment, study timelines, regulatory documents, site payments, and subject payment documents.
- Collaborated with legal, improved legal review of clinical operations and enhanced contract administrator function.
- Implemented broad-scale organization change and transformed research-based functions.
- Worked with finance department and built accurate financial statements for clinical research and fostered enterprise-wide view of financial impact of clinical research.
- Fostered excellence by example by "setting pace" and being hands on mentor to clinical staff.
- Set clear, compelling goals for staff and monitored productivity and output for research personnel
Education
Bachelor’s Degree - Health/Health Care Administration
University of Phoenix
05.2005
Some College (No Degree) - Sports Medicine
University of North Carolina At Greensboro
Greensboro, NCSkills
- Analytical Thinking
- Management Coaching
- Global Thinking
- Project Management
- Scheduling and Coordinating
- Staff Management
- Strategic Planning
- Issue and Conflict Resolution
- Managing Operations and Efficiency
- Contract Development and Management
- Employee Coaching and Motivation
- Productivity Performance
- Business Analysis
- Disaster Recovery Planning
- Google Drive
Accomplishments
- CERTIFICATIONS:
- Certified Phlebotomist
- Certified Ophthalmic Technician
- Certified Medical Assistant
- Certified Emergency Medical Technician
- Certified Clinical Research Associate
- Certified CPR Basic Life Support for Healthcare Provider
- Certified Advanced Cardiovascular Life Support
- Certified IATA
- Certified GCP/ICH
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Don’t postpone joy until you’ve learned all your lessons. Joy is your lesson.
Alan Cohen
Timeline
Consultant
Care Access Research
10.2021 - Current
Clinical Research Manager
North Carolina Nephrology
01.2020 - 04.2022
Director of Clinical Research Operations (Contracted Consultant)
Azidus, Inc
07.2016 - 12.2017
Director of Clinical Research (Contracted Consultant)
AXIS Clinicals Inc
04.2015 - 07.2016
Director of Clinical Operations, Consultant
Hill-Top Research, Inc
12.2012 - 11.2013
Director of Clinical Operations/ Business Development (Contracted Consultant)
Discovery Medical Research
07.2011 - 12.2012
Site Manager/CRA, Site manager
Medical Research South
12.2010 - 06.2011
Practice Manager/Project Manager (Contracted Consultant)
Diversified Research, Inc
11.2009 - 11.2010
Director of Clinical Research
Guilford Neurologic Associates
05.2007 - 10.2009
Bachelor’s Degree - Health/Health Care Administration
University of Phoenix
Some College (No Degree) - Sports Medicine
University of North Carolina At Greensboro
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