Chris Rinehart
Paola,KS
Summary
TWENTY YEARS of Phase I-III clinical research experience including inpatient and outpatient trials. Highly motivated, goal-driven research professional who has consistently exceeded performance expectations. Well-versed in building positive working relationships. Skilled at overseeing complex, high-value studies with excellent organizational skills. Accomplished in building sponsor trust and earning long-term business.
Overview
20
20
years of professional experience
Work History
Project Manager
Johnson County Clin-Trials
01.2017 - 12.2019
- Supervised research team of 50 staff members, including Business Development, Regulatory, Recruiting, Operations, Laboratory, Clinical Coordinators, Pharmacy, Quality Control, Quality Assurance and Data Management to achieve organizational goals and sponsor milestones.
- Provided outstanding service to clients through effective communication and assertiveness in effort to promote future business opportunities (Averaged 8-10 studies/year from repeat sponsor business).
- Drove team success through shared vision and dedication of quality performance.
- Implemented company methodologies and processes to increase productivity and reduce noncompliance.
- Developed organizational plans and identified resources required to meet enrollment timelines (10,000 subjects/year) and modified operational practices through informed judgment to achieve optimal performance.
- Oversaw Quality Control and Quality Assurance with track record of timely data entry while maintaining low query rate and quick query resolution.
Operations Manager
Johnson County Clin-Trials
01.2008 - 12.2016
- Directed day-to-day operations focused on good clinical practice and continuous improvement to meet sponsor timelines.
- Established positive and effective communication among staff and senior leadership, reducing misunderstandings and ineffectiveness.
- Developed and implemented daily plans such as study logistics, employee assignments and operational strategies to optimize productivity and increase profits by 40%.
- Cultivated strong relationships with clients (sponsors & subject volunteers) to increase overall experience, satisfaction and retention.
- Supervised and mentored research staff of 35 employees, including interviewing, selecting and training new hires.
- Managed Quality Control and Quality Assurance with track record of timely data entry while maintaining low query rate and quick query resolution.
Clinical Research Coordinator
Johnson County Clin-Trials
06.2005 - 12.2007
- Only full-time employee in new clinical research startup.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Conducted staff meetings to provide protocol training and study status updates, including interaction to resolve site issues and facilitate project timelines.
- Working knowledge of Good Clinical Practice, ICH Guidelines and US Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), HIPPA Compliance.
- Efficient in MS Office applications, Medidata RAVE, SBIR
Clinical Research Coordinator
Vince And Associates Clinical Research Inc.
04.2005 - 06.2005
- Established vaccine program with initial study consisting of 300+ elderly subjects for seasonal influenza.
- Developed protocols and practices for In-House research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Clinical Research Coordinator
PRA Health Sciences Inc.
01.2002 - 04.2005
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Gathered, processed and shipped lab specimens.
- Working knowledge of Good Clinical Practice, ICH Guidelines and US Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), HIPPA Compliance.
Clinical Research Nurse
PRA Health Sciences Inc.
03.2000 - 01.2003
- Managed nurses and nursing activities in outpatient and inpatient settings, providing comprehensive guidance and maintaining outstanding patient monitoring and documentation.
- Collaborated with PIs, study managers and operations manager to adhere to study protocol and develop and implement operational strategies.
- Conducted ongoing monitoring and evaluations of subject AEs and updated PIs and study managers accordingly.
- Adhered to strict Good Clinical Practice and OSHA guidelines at all times.
- Educated subjects and answered questions concerning study participation and requirements.
- Working knowledge of Good Clinical Practice, ICH Guidelines and US Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), HIPPA Compliance.
Education
Bachelor of Science - Nursing
MidAmerica Nazarene University
Olathe, KS05.1997
Skills
- Communication (Excellent Verbal, Written, and Listening)
- Teamwork (Continuously Building Positive Working Relationships)
- Organization (Able to Prioritize, Manage Time Well, Working Efficiently and Productively)
- Leadership (Setting Good Example in Motivating Others)
- Calm (Works Well Under Pressure Without Becoming Too Overwhelmed or Stressed)
- Motivation (Enjoys Daily Challenges in Research and Being Able to Produce Quality Work)
AREAS OF EXPERTISE
- Pediatric, Adult and Elderly Populations - IV, Oral, IM, SQ, Nasal and Topical Administrations
- Vaccines: Seasonal Influenza (including nasal swabs), Swine Flu, Avian Flu, Cholera, Hepatitis B, RSV, HPV, Group B Strep, Botulinum, Plague, Dengue Fever, TB, Meningitis, Pneumococcal, Chikungunya
- Gastrointestinal: Traveler's Diarrhea (including skin patch assessments)
- Neurology: including administering mini mental exams
- Rheumatology: Rheumatoid Arthritis
- Cardiovascular: HTN
- HEENT: Otitis Media
- Psychological: ADD and ADHD
- Asthma and Allergy
- Communicable Disease: Ebola
Timeline
Project Manager
Johnson County Clin-Trials
01.2017 - 12.2019
Operations Manager
Johnson County Clin-Trials
01.2008 - 12.2016
Clinical Research Coordinator
Johnson County Clin-Trials
06.2005 - 12.2007
Clinical Research Coordinator
Vince And Associates Clinical Research Inc.
04.2005 - 06.2005
Clinical Research Coordinator
PRA Health Sciences Inc.
01.2002 - 04.2005
Clinical Research Nurse
PRA Health Sciences Inc.
03.2000 - 01.2003
Bachelor of Science - Nursing
MidAmerica Nazarene University