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
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