Kelly Haddock
Danville,PA
Summary
Motivated Research Project Manager with demonstrated knowledge of research best practices and health care operations. Proven skills in enhancing productivity, efficiency, and bottom-line profits with forward-thinking leadership. Bringing 17 years of experience in field and ready to take on challenging, growth-oriented role in research.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Program Development Analyst
Rutgers Cancer Institute of New Jersey
01.2024 - Current
- Communication with CINJ staff, including Investigators, Network staff, industry sponsors, monitoring staff from national oncology cooperative groups, Cancer Trials Support Unit (CTSU), Food and Drug Administration (FDA), and others
- Coordinates and maintains the process of obtaining IRB approval for new protocols, including study start-up, protocol amendments, annual reviews, study closures
- Collects and maintains all regulatory documentation
- Understands and anticipates the needs of study’s sponsor
Flex Certified Pharmacy Technician III
Geisinger Medical Center
12.2004 - Current
- Worked Central Inpatient Pharmacy since 2004 and continue with skills as flex position
- Prepare medications for entire facility (400 + Beds) working and performing duties assigned by pharmacists
- Prepared intravenous solutions, admixtures, respiratory drugs, and other solutions using aseptic techniques
- Answered incoming phone calls and addressed questions from customers and healthcare providers
- Assisted in preparation, distribution, and storage of pharmaceuticals
- Counted, measured, and compounded medications following standard procedures
- Helped pharmacist clear problematic prescriptions and address customer questions to keep pharmacy efficient
Regulatory Compliance Coordinator
Actalent Scientific
09.2022 - 01.2024
- Monitoring and developing processes to assure that the Regulatory Affairs team meet and/or exceed research standards of accurate and quality work at the Rutgers Cancer Institute of New Jersey
- Collaborates closely with Investigators and the research team to ensure key federal/state/local regulatory objectives are met and ethical obligations are kept
- Educates staff on current and changing FDA regulations, ICH guidelines, and policies
- Reports status of overall quality on a regular basis, including summary information across all Disease Specific Groups (DSGs), trials by sponsor type, and by research site
Research Project Manager
Geisinger Medical Center
06.2019 - 09.2022
- IRB/Regulatory Management in both clinical and investigator-initiated research projects
- Manage research study compliance with local, state, and federal regulations
- Manage multiple studies submissions and have knowledge of Institutional Review Board
- Study start-up and implementing the study
- Project planning, tracking and management
- Study Finances/Preparation of Budgets
- Data Collection
- Submissions of external and internal grants
Credentialing Associate
Geisinger Medical Center
02.2017 - 06.2019
- Developed and maintained Resident/Fellow Credentialing for all new and returning trainees for facility
- Created and filed required licensing requirements with Pennsylvania State Board
- Compliance with J-1 Visas through immigration and Naturalization Service and Educational Commission for Foreign Medical Graduates (ECFMG)
- Conducted primary source verifications such as background checks and board certifications
- Received and evaluated applications to look for missing and inaccurate information
- Obtained NPI numbers for providers and facilities and updated existing profiles
- Received, recorded, and addressed incoming and outgoing communication via telephone and email
Project Coordinator
Geisinger Medical Center
12.2012 - 02.2017
- Managed IRB submissions and prepared subject consent forms for fifty plus research studies
- Maintained regulatory documents
- Supervised multiple projects from project start through delivery by prioritizing needs and delegating assignments
Administrative Regulatory Coordinator
Geisinger Medical Center
02.2007 - 12.2012
- Company Overview: Cancer Service Line
- Administrative for Principal Investigator for research department
- Duties included, but not limited to management of schedule, ensuring all travel arrangements
- Responsible for thirty physician NCI documents and related data
- Managed and maintained study documents for over fifty studies for departmental research studies in Hematology/Oncology Research
- Collaborated with internal team members to accomplish regulatory goals and achieve full compliance with all research studies
- Cancer Service Line
Education
MBA - Project Management
Ashford University
San Diego, CA11.2015
Bachelor of Arts - Health Care Administration
Ashford University
Clinton, Iowa02.2011
Skills
- Project Management
- Data Collection
- Data Entry
- Electronic Medical Record (EPIC)
- Clerical
- Financial Management
- Budgeting
- Planning and Coordination
- Microsoft Office
- Detail-oriented
- Teamwork
- Certified Pharmacy Technician
- Red Cap
Certification
- CCRP
- CPht
Timeline
Program Development Analyst
Rutgers Cancer Institute of New Jersey
01.2024 - Current
Regulatory Compliance Coordinator
Actalent Scientific
09.2022 - 01.2024
Research Project Manager
Geisinger Medical Center
06.2019 - 09.2022
Credentialing Associate
Geisinger Medical Center
02.2017 - 06.2019
Project Coordinator
Geisinger Medical Center
12.2012 - 02.2017
Administrative Regulatory Coordinator
Geisinger Medical Center
02.2007 - 12.2012
Flex Certified Pharmacy Technician III
Geisinger Medical Center
12.2004 - Current
MBA - Project Management
Ashford University
Bachelor of Arts - Health Care Administration
Ashford University
Similar Profiles
Paul MasakaPaul Masaka
Undergraduate Research Intern at Rutgers Cancer Institute Of New JerseyUndergraduate Research Intern at Rutgers Cancer Institute Of New Jersey
Emefa AdjokatcherEmefa Adjokatcher
Program Manager at Rutgers Cancer Institute Of New JerseyProgram Manager at Rutgers Cancer Institute Of New Jersey
Ashwini RAOAshwini RAO
EXPERIENCE Nurse clinician at Rutgers Cancer Institute of New JerseyEXPERIENCE Nurse clinician at Rutgers Cancer Institute of New Jersey