Michelle Gaines
Arlington,TX
Summary
Experienced professional with a strong background in clinical research, regional management, and team leadership. Demonstrated expertise in strategic planning, operational efficiency, and achieving performance outcomes. Proven ability to foster collaboration, adapt to change, and consistently deliver measurable results. Recognized for effective communication, exceptional problem-solving abilities, and unwavering commitment to organizational goals.
Overview
28
28
years of professional experience
Work History
Regional Director, Clinical Ops
Objective Health
11.2023 - 09.2024
- Trained and guided team members to maintain high productivity and performance metrics.
- Led hiring, onboarding and training of new hires to fulfill business requirements.
- Supervised operations staff at sites in Texas, California, Missouri, Alabama and South Carolina.
- Kept employees compliant with company policies and procedures.
- Conducted regular performance reviews, identifying areas for improvement and developing action plans to address them.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Empowered employees to take ownership of their responsibilities, leading to increased accountability and improved performance outcomes.
Sr. Clinical Ops Supervisor
Labcorp Drug Development
01.2021 - 10.2023
- Mentored junior staff members in their career development, sharing knowledge from years of experience in the field at a 100-bed Phase I Unit.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
- Resolved conflicts among team members promptly, maintaining a harmonious working environment conducive to productivity.
- Demonstrated commitment to the organization's core values, leading by example and fostering a culture of excellence.
- Enhanced communication within the team by holding regular meetings and encouraging open dialogue among all members.
- Coordinated Phase I clinical research trials.
Site Director
Synexus
12.2018 - 12.2020
- Managed a team of professionals, ensuring high-quality performance and adherence to company standards.
- Collaborated with cross-functional teams to achieve project milestones on time and within budget constraints.
- Successfully managed several projects from inception through completion demonstrating strong project management skills.
- Cultivated a culture of excellence by setting clear expectations for team members while providing support for their professional development goals.
- Maintained compliance with regulatory requirements while continuously seeking opportunities for process improvement based on best practices.
- Coordinated clinical research trials, Phases 2-4.
- Optimized resource allocation, reducing costs and improving overall site productivity.
- Proven record of developing and implementing policies to ensure compliance with state and federal regulations.
Director of Clinical Research
Cutting Edge Research
01.2015 - 11.2018
- Negotiated contracts with sponsors, ensuring timely delivery of services at competitive prices while maintaining high-quality standards.
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
- Designed and introduced leadership development, coaching and team management model, resulting in promotion of employees into increased levels of responsibility.
- Implemented process improvements that increased throughput without compromising quality or safety standards.
- Managed complex budgets for multiple concurrent studies, optimizing resource allocation to maximize return on investment.
- Led efforts to maintain a strong quality assurance program, conducting regular audits and implementing corrective measures as needed.
- Primary Rater for protocol required psychological and neurological assessments.
- Coordinated clinical research trials in Phases 1-4.
Owner/Director of Quality Assurance
Eminence Research
12.2004 - 12.2014
- Managed day-to-day business operations.
- Trained and motivated employees to perform daily business functions.
- Managed financial aspects of the business, including budgeting, financial reporting, and tax preparation.
- Streamlined operations to improve efficiency, enabling more time to be spent on strategic planning and decision making.
- Coordinated Phase 2-4 clinical research trials.
- Oversaw daily operations, ensuring all tasks were completed accurately and efficiently by team members.
- Ensured regulatory compliance by staying abreast of industry-related changes and implementing necessary policies or procedures as needed.
- Established foundational processes for business operations.
- Primary Clinical Rater
- Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
Director of Clinical Research
Pahl Brain Associates
07.2001 - 11.2004
- Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to employees.
- Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, benefits administration and general liability.
- Designed and introduced leadership development, coaching and team management model, resulting in promotion of employees into increased levels of responsibility.
- Advised on regulatory submissions, providing expert guidance to ensure successful approval of investigational products for human use.
- Managed complex budgets for multiple concurrent studies, optimizing resource allocation to maximize return on investment.
- Primary Rater for psychological and Neurological protocol required assessments.
- Coordinated Phases 2-4 clinical trials.
Clinical Research Coordinator
Pahl Brain Associates
01.1997 - 06.2001
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Gathered, processed, and shipped lab specimens.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Complied with research protocols by providing ongoing quality control audits.
- Screened patient records, databases, and physician referrals to identify prospective candidates for Phase 2-4 research studies.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Primary Rater for protocol required psychological and neurological assessments.
Education
Master's Degree - Counseling Psychology
Oklahoma City University
Oklahoma City, OK12.1999
Bachelor's Degree - Psychology/Sociology Chemical Dependency
University of Central Oklahoma
Edmond, Oklahoma12.1995
Skills
- Psychiatric and Neurological Assessment Rater
- Venipuncture
- KPI tracking
- Collect Biological Samples
- Performance improvement
- Complete Source Documents
- Staff training/development
- Vital Signs
- Management team building
- Process Lab Samples
- Performance evaluation and monitoring
- Perform Fibroscans
- Obtain Medical History
- Obtain Concomitant Medications
- Perform EKG
- Informed Consent Process
- Manage Investigational Product
- Complete CRFs
- Resolve Queries
- Report SAEs
- Operations management
- Staff training and development
- Hiring and onboarding
- Staff management
- Process improvements
- Budget development
- Budget Negotiation
Areas of Research Experience
- Phase I – Phase IV
- Oncology
- Mild Cognitive Impairment
- Alzheimer's Disease
- Medical Devices
- Ulcerative Colitis
- Urinary Incontinence
- Peyronie's Disease
- GERD
- Biomarkers
- Parkinson's Disease
- MASH/NASH
- Erosive Esophagitis
- Celiac Disease
- Diabetes Mellitus-Type 2
- Migraine
- Primary Hyperoxaluria Type 1
- Schizophrenia
- Panic Disorder
- Fibromyalgia
- Major Depressive Disorder
- Bipolar Disorder
- Hypertension
- Hypercholesterolemia
- COPD
- Asthma
- Vascular Dementia
- Mixed Dementia
- Nonvalvular Atrial Fibrillation
- Autism
- Schizoaffective Disorder
- Vaccines
- Major Depression with Psychotic Features
- Insomnia
- Epilepsy
- Obesity
- Smoking Cessation
- ADHD
- Cognitive Functioning in children
- Anxiety Disorder
- Chronic Pain
- Osteoporosis
- Obsessive Compulsive Disorder
Rater Training Certifications
- Alzheimer's Disease Assessment Scale
- Mini-Mental Status Examination
- Global Assessment of Functioning
- Wechsler Adult Intelligence Scale-Revised
- Wechsler Memory Scale
- Wechsler Preschool and Primary Scale of Intelligence-Revised
- Wechsler Individual Achievement Test
- Wechsler Intelligence Scale for Children-Third Edition
- Wechsler Abbreviated Scale of Intelligence 2nd Edition
- California Verbal Learning Test
- Continuous Performance Test
- Verbal Fluency Examination
- Wisconsin Card Sorting Test
- Positive and Negative Syndrome Scale
- Beck Depression Inventory
- Rey Auditory-Verbal Learning Test
- Trail Making Test-Parts A and B
- Spatial Working Memory Test
- Minnesota Multiphasic Personality Inventory-Second Edition
- Behavior Pathology in Alzheimer's Disease Rating Scale
- Alzheimer's Disease Cooperative Study-Activities of Daily Living
- Hamilton Depression Scale
- Intersept Scale for Suicidal Thinking
- Clinical Global Impression for Severity of Suicide
- Clinical Global Impression for Severity of Psychosis
- Calgary Depression Scale
- Halstead-Reitan (Finger Tapping)
- Cahill Memory Paradigm
- Controlled Oral Word Association
- Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change
- Clinician's Interview-Based Impression of Severity
- Neuropsychiatric Inventory
- Neuropsychiatric Inventory Distress Scale
- Neuropsychiatric Inventory-Nursing Home version
- Cornell Scale for Depression in Dementia
- Disability Assessment for Dementia
- Hamilton Anxiety Scale
- Auditory Verbal Learning Test
- Selective Reminding Test
- Structured Clinical Interview for DSM-IV I Disorders
- Brief Psychiatric Rating Scale
- Montgomery-Asberg Depression Rating Scale
- Barnes Akathisia Rating Scale
- Simpson Angus Scale
- UKU Side Effect Rating Scale
- Arizona Sexual Experiences Scale
- SF-36 Health Status Survey (Interviewer administered)
- Extrapyramidal Symptom Rating Scale
- Cohen-Mansfield Agitation Inventory
- Abnormal Involuntary Movement Scale
- Personality Inventory for Children
- Revised Children's Manifest Anxiety Scale
- Reynolds Adolescent Depression Scale
- Children's Depression Inventory-Revised
Training
- Good Clinical Practice - CITI
- IATA/Dangerous Goods - Mayo Clinic
Licensurecertifications
- Licensed Behavioral Practitioner, #89, Oklahoma, Mental Health Therapist, 01/01/01, Present
- ACRP-CP, National, 01/01/23, Present
- ACRP-CCRC, National, 01/01/03, 12/31/13
Timeline
Regional Director, Clinical Ops
Objective Health
11.2023 - 09.2024
Sr. Clinical Ops Supervisor
Labcorp Drug Development
01.2021 - 10.2023
Site Director
Synexus
12.2018 - 12.2020
Director of Clinical Research
Cutting Edge Research
01.2015 - 11.2018
Owner/Director of Quality Assurance
Eminence Research
12.2004 - 12.2014
Director of Clinical Research
Pahl Brain Associates
07.2001 - 11.2004
Clinical Research Coordinator
Pahl Brain Associates
01.1997 - 06.2001
Master's Degree - Counseling Psychology
Oklahoma City University
Bachelor's Degree - Psychology/Sociology Chemical Dependency
University of Central Oklahoma
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