Katrina S. Brook
MI
Summary
Organized and dependable CRA with strong people leadership readiness, driving cross-functional collaboration, CRA mentoring, proactive risk identification, audit readiness and ICH-GCP compliance to ensure high quality clinical trial execution and on-time delivery within a sponsor-aligned FSP model.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
ThermoFisher Scientific
05.2022 - Current
- Conduct clinical trials in accordance with Good Clinical Practice (GCP) guidelines, ensuring safety and well-being of study participants.
- Monitor study sites to ensure compliance with study protocols, regulatory requirements, and standard operating procedures (SOPs).
- Skilled in root cause analysis and problem solving through negotiation with stakeholders.
- Maintains frequent contact between monitoring visits with investigative sites to confirm protocol adherence, follow up on identified issues and progress with data entry per defined timelines.
- Collaborates with cross-functional teams, including, site staff, clinical operations, data management, and sponsors to ensure timely and accurate data collection and reporting.
- Maintains up-to-date knowledge of relevant regulations, guidelines, and industry best practices to ensure compliance and quality in clinical trial conduct.
- Technical systems and competency with Microsoft Office, Covance Cockpit, Inform, Veeva, Complion, CRIO, and SBIR.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
- Applied extensive clinical knowledge to troubleshoot and resolve regulatory document issues.
- Supported development and delivery of department training to maximize success of clinical research.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Liaised with local delivery lead to effectively resolve study-related issues.
Certified Inpatient OB- Registered Nurse
Travel Nurse - Aya Healthcare & RN Network
07.2021 - 03.2022
- Labor and Delivery Recovery Postpartum
- LDRP Travel RN at Critical access hospitals in Florence, Oregon & Presque Isle, Maine
- Communicated with healthcare team members to plan, implement and enhance treatment strategies.
- Leveraged feedback and process improvement opportunities to create safer and healthier environment and increase patient satisfaction.
Certified Inpatient OB- Registered Nurse
Sparrow Hospital
01.2011 - Current
- Labor and Delivery (LD)
- Committee member and Peer Educator, identify and communicate policies and processes to reduce negative outcomes during the perinatal stage including, reducing cesarean sections, promoting physiologic birth, and reducing racial and socio-economic biases.
- Primary care for patients intrapartum, antepartum, and immediately postpartum
- Collaborate with physicians, residents and midwives to develop and implement plan of care for patients and newborns.
- Provide patient and family education on pregnancy, labor and delivery, discharge planning, and pathophysiologic conditions of pregnancy and postpartum.
- Assist in OR for surgeries (cesarean section, cerclage, emergent hysterectomies and dilation and curettage)
- Conduct and evaluate fetal monitoring to assess maternal and fetal well being
- Skilled in EPIC and PeriWatch computer charting
- Certified in BLS, and Neonatal Resuscitation Program (NRP), Nationally certified in External Fetal Monitoring and Inpatient Obstetrics
- Float to work as RN in OB triage, Mother- Baby Postpartum, and OB Special Care Units
- Promoted patient and family comfort during challenging recoveries to enhance healing and eliminate non-compliance problems.
Program Director
Redemption Fitness
01.2019 - 01.2021
- Lead the sales activity of the gym, including membership sales, promotional activities, and general administration with aim of driving business forward.
- Assist in management of coaching staff.
- Collaborate and problem solve issues as they arise from members and staff.
- Negotiated program contracts and agreements to obtain cost-effective pricing.
- Monitored program performance to identify areas for improvement.
- Identified risks and developed mitigation plans.
Registered Nurse
Sparrow Hospital
01.2010 - 01.2011
- Cardiac Intensive Care Unit (CCU)
- Cared for the critically ill patients in the CCU.
- Prioritized and triaged care in stressful critical care situation, including patient assessment, review of labs and diagnostic testing, and communication with multidisciplinary team members.
- Demonstrated effective teamwork as a primary member of the code and rapid response teams.
- Provided quality nursing care according to care standards to both patients and families.
Registered Nurse
Allegiance Health
01.2009 - 01.2010
- Cardiac Universal Bed Unit (CUB)
- Primary care for patients undergoing cardiac, vascular, and thoracic procedures and/or surgeries.
- Delegates to and collaborates with other members of the health system in coordinating patient care.
- Discharge teaching regarding cardiac diet, medication regimen, and exercise post MI
- Skills frequently utilized include titration of medications, lab draws, IV insertions, cardiac catheterization sheath pulls, EKG readings.
- Float to work as RN on Cardiac Catheterization and Special Procedures Lab
Learning and Assessment Center Instructor
Michigan State University
01.2008 - 01.2010
- Healthcare Professionals
- BCLS instruction
Activity Therapist
Sparrow Health Center
01.2001 - 01.2010
- Geriatric, Adult, Substance Abuse, Partial Hospitalization Behavioral Health
- Certified Therapeutic Recreation Specialist
- Evidence based practice implemented for reducing agitation in patients with dementia.
- Group and individual therapy provided with focus on physical health maintenance, self-esteem development and growth, feelings expression, coping skills and cognitive stimulation.
- Active participant of the interdisciplinary team, assessing and developing care plans for individuals
Birth Doula
Doulas of North America
01.2006 - 01.2009
- Prenatal, Antenatal and Immediate Postpartum
- Non-medical physical and emotional support, childbirth education, and breastfeeding support
- Support for patients and families through the stages of labor and delivery and postpartum
Education
Bachelor of Science - Nursing
Michigan State University
08.2009
Masters Programs - Gerontology and Recreation
UNC at Greensboro
05.2001
Bachelor of Science - Parks, Recreation, and Tourism Resources
Michigan State University
08.2000
Skills
- Cross-departmental teamwork
- Following regulatory guidelines
- Visit oversight
- Comprehensive documentation
- Collaborative skills training
- Site operations management
- Quality management
- Good clinical practice
- Technical report writing
- Commitment to accountability
Accomplishments
My exceptional contributions to GMASE FSP University, including highly praised interactive presentations and strong connections with CRAs, participation in global workstreams in diversity and AI development highlight my ability to lead and inspire effectively. My dedication to excellence, embodiment of the 4i values, and forward-thinking mindset make me an ideal candidate for the Associate Clinical Manager role.
Certification
ACLS, NRP, STABLE, BLS, RNC-OB, CEFM, AWONN Advanced
Timeline
Clinical Research Associate
ThermoFisher Scientific
05.2022 - Current
Certified Inpatient OB- Registered Nurse
Travel Nurse - Aya Healthcare & RN Network
07.2021 - 03.2022
Program Director
Redemption Fitness
01.2019 - 01.2021
Certified Inpatient OB- Registered Nurse
Sparrow Hospital
01.2011 - Current
Registered Nurse
Sparrow Hospital
01.2010 - 01.2011
Registered Nurse
Allegiance Health
01.2009 - 01.2010
Learning and Assessment Center Instructor
Michigan State University
01.2008 - 01.2010
Birth Doula
Doulas of North America
01.2006 - 01.2009
Activity Therapist
Sparrow Health Center
01.2001 - 01.2010
Masters Programs - Gerontology and Recreation
UNC at Greensboro
Bachelor of Science - Nursing
Michigan State University
Bachelor of Science - Parks, Recreation, and Tourism Resources
Michigan State University
Community Service
- His Cup Runneth Over, Executive Board Member for Mobile Soup Kitchen
- Upwards Sports, Basketball Coach
- Holt Public Schools, RN representative on Council for Health Advisory Board
- RoboRams, Team Mentor – Impact Leader