clinical research program manager resume example with 20+ years of experience
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Energetic, dedicated, balanced, priority-driven Clinical Research Professional offering over 25 years experience in research and nursing. Seeking a challenging position of responsibility, and leadership that lends to professional and personal growth.
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- Employed active listening and interpersonal talents to effectively interact with various individuals, including physicians, patients and fellow employees.
- Delegated tasks to each member of staff and oversaw task completion, offering assistance to promote success.
- Interviewed applicants and made recommendations for new hires.
- Managed clinical operations and procedures and enforced adherence to federal and state regulations and healthcare law requirements.
- Improve policies and procedures through development, implementation, revision and evaluation of new protocols.
- Enforced compliance with local, state, and federal healthcare regulations, and HIPAA compliance.
- Coordinated weekly work schedules for department employees.
- Developed and initiated departmental goals, standards of performance, policies and procedures.
- Oversaw clinical operations and procedures while remaining current of federal and state regulations to ensure organization processes were fully compliant with new healthcare law requirements.
- Provided Team member oversight for over 20 team members.
- Managed overall operation of the CCBD programs (Experimental Therapeutics programs (ETP), Children's Oncology Group (COG), Neuro-oncology, Hematology and Surge) by handling financial management, quality assurance,
- Coordinated with Physicians and Director to develop programs targeting departmental competencies, individual performance, patient safety and service-related issues.
- Onboarded and provided training for new team members, both University of Colorado and Children's. Successfully provided training and education for Clinical research Coordinators, Data Coordinators, Regulatory Specialists, Tumor registrars, and database Coordinators.
- Improved research-based approaches through participation in research and evidence-based audits.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Checked electronic data capturing systems for integrity and compliance.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Conducted all activities according to defined project-specific quality and performance standards.
- Performed pre-study, closeout and interim visits to check on study activities.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
- Participated in educational training, activities and professional development programs.
- Maintained strict confidentiality to keep personal information and collected data private.
- Evaluated proof of eligibility and consent for participants.
- Collected and authenticated data collection forms to read and interpret complex clinical protocols.
- Attended COG meetings and reported on activities and resolutions.
- Read physician orders and administered therapies, treatments, and medications.
- Explained treatment procedures, medication side effects, special diets, and physician instructions to patients.
- Reviewed physician orders and participated in medication management to optimize patient safety.
- Maintained reports to provide oncoming shift with full patient status.
- Collaborated with interdisciplinary healthcare professionals to create, implement, and adapt individualized care plans.
- Prioritized patient care assignments based on patient conditions to achieve optimal outcomes.
- Instructed patients, families and caregivers on diagnoses, chronic disease management, and medication self-management.
- Mentored new nurses on practices and procedures to drive patient outcome goals.
- Monitored and recorded patient condition, vital signs, and medication side effects.
- Administered medications, tracked dosages, and documented patient conditions.
- Communicated effectively with physicians and provided support for Oncology, Medical surgical and cystic fibrosis patients.
Hillsborough Community College - Tampa, FL
Metropolitan State University of Denver - Denver, CO
Professional Activities:
01/2021 - Present – COG CRA Discipline Chair
11/2019 - 12/2020 - COG CRA Discipline Chair-Elect
01/2020 - 12/2020 - COG CRA Discipline Vice-Chair
04/2012 - 12/2020 - IPMC CRA Liaison
2009 - Present - COG CRA Communications Committee Member
2009 - 2014 - COG CRA Nominating Committee
04/2012 - 12/2020 - Membership Committee CRA Liaison
04/2012 - 09/2020 - COG CRA Steering Mentoring, Membership Chair
2006 - Initial Task Force to Develop CRA on-line Educational Modules
Clinical Trial participation
08/2003 – 3/31/2021 - AALL0331 Standard Risk ALL Study CRA
03/2012 - Present - AALL1131 High Risk B- ALL/LLY Study CRA
05/2018 - Present - AALL1732 High Risk B-ALL/LLY Study CRA
Certifications:
Basic Life Support for Healthcare providers (BLS) expires 9/2022
Certified Clinical Research Professional (CCRP) (SOCRA) expires 04/01/2023
Certified Pediatric Hematology/Oncology Nurse (CPHON) expires 12/31/2023
Chemotherapy/Biotherapy Expires 12/31/2022
License:
RN State of Colorado License # 0127665 Expires 09/30/2022
Memberships:
SOCRA - 4/2003 to present
APHON - 1996 to present
COG lead CRA - 4/1998 to present
Publications & Posters
Smolik S, Arland L, Hensley M, Schissel D, Claire B, Thomas K, Rodgers C. Assessment tools for
peripheral neuropathy in pediatric oncology: a systematic review from the Children’s Oncology Group.
Journal of Pediatric Oncology Nursing, 2018 Jul/Aug;35(4):267-275. doi: 10.1177/1043454218762705. Epub 2018 Mar 22.
Hendricks T, Pinner K, Schissel D, Claire B, Lugo G, Widener M, Channell J, Dyer M, t Macy M, Coughlin R, Telang, J, Children’s Hospital Colorado, Anschutz Medical Campus, CO. A Systematic Approach to Standardizing Clinical Research Care Across Disciplines, accepted for poster presentation at APHON Sept 2019
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Resume Overview
School Attended
- Hillsborough Community College
- Metropolitan State University of Denver
Job Titles Held:
- Clinical Research Program Manager
- Clinical Research Associate
- Staff RN Adolescent Unit
Degrees
- Associate of Science
- Bachelor of Arts
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