Carol Lyn Sprinkle
Magee Women's Hospital of UPMC, Center for Family Planning Research
Pittsburgh,PA
28
years of professional experience
Operations professional with hands-on experience in coordinating and optimizing workflows. Strong focus on team collaboration and ensuring smooth operations. Skilled in logistics, project management, and problem-solving. Reliable and adaptable, ready to meet changing demands and deliver consistent results.
Work History
Research Operations Coordinator
8 Years 3 Months- Coordinate Phase I, II and III clinical trials including contraceptive, STI prevention and HIV prevention trials. Duties include organization of study start-up visits and ongoing monitoring visits, creating study specific source documents, SOPs and study other required study documents and logs, set up hospital required lab accounts, organize study trainings for all staff, and serve as the lead on communications with the study sponsor.
- Coordinated Phase I, II, and III clinical trials for contraceptive, STI prevention, and HIV prevention. Organized study start-up and monitoring visits, created source documents and SOPs, and established hospital lab accounts.
- Executed IRB submissions for ongoing clinical trials, including initial submissions, protocol amendments, continuing reviews, and reporting of unanticipated events and serious adverse events.
- Maintain Investigator Site Files for all ongoing clinical trials. Assemble 1572s, Financial disclosures, and study manuals. Collect and maintain CV's, licenses, CITI training and lab certifications.
- Ensure compliance with FDA, ICH and GCP guidelines.
- Ordered all study-related and office equipment and maintained proper equipment functionality.
- Coordinated study storage on site and managed shipments to the off-site storage facility.
- Assisted both the Study Investigators and Research Administration on the creation of study budgets, reviewing and approving study related invoices.
- Developed internal auditing tools to enhance compliance and oversight of clinical trials.
- Coordinated the posting of positions and interviewed candidates for the research office.
- Supervise and coordinate training for all research staff, overseeing staff daily.
- Conduct study specific study visits for all clinical trials.
- Serve as a point of contact in assisting the Family Planning Fellows with the development of source documents, databases, and study execution.
- Supervised research staff by providing ongoing feedback and conducting performance evaluations.
Research Principal Sr.
2 Years 2 Months- Coordinated Phase I, II, and III clinical trials in research office to ensure compliance and successful execution.
- Supervised research staff to maintain high standards in the conduct of study trials.
- Perform all study functions of Research Study Coordinator
- Assisted Regulatory Coordinator in collecting regulatory documents and ensuring staff utilized current IRB-approved materials and participant recruitment resources.
Research Study Coordinator
3 Years 7 Months- Coordinated multiple trials in research office, ensuring compliance and adherence to study protocols.
- Conducted participant study visits on associated trials.
- Audited charts, managed data entry, and resolved queries to maintain data integrity for associated trials.
- Assisted the regulatory coordinator to ensure all current IRB consents and materials are being used in the trials as well as making sure all relevant documents are available for study monitors.
- Assisted with auditing charts and data entry and query resolution on associated trials.
- Supported principal investigator by managing budgetary requirements and securing appropriate space in Clinical and Translational Research Center for participant visits.
- Assisted principal investigator with budgetary needs in using the Clinical and Translational Research Center to ensure room space is available for conducting participant visits.
Clinical Research Associate
3 Years 10 Months- Managed daily operations, coordinated work activities, maintained schedules and call-offs, and ensured appropriate provision and maintenance of office space, supplies, equipment, and assistance for medical staff and patient care.
- Supervises and trains assigned research personnel.
- Coordinator of two multi-center trials
- Coordinated logistics for two multi-center clinical trials
- Coordinated study start-up meetings with sponsors, arranged monitoring visits, and met with study monitors during site visits to review study progress and address any emerging issues.
- Communicated with study sponsors and investigators on trial implementation and resolved study-related issues as they arose.
- Audit charts for accuracy
- Executed functions of clinical research assistant.
Senior Clinical Research Assistant
1 Year 5 Months- Executed research assistant functions, supporting study protocols and data collection.
- Trained new research staff on office and study protocols to ensure compliance and efficiency.
- Facilitated visits for study participants to gather data.
- Perform the functions of a research assistant.
Director of Counseling
2 Years 7 Months- Supervised and trained paraprofessional counselors, volunteers, and interns to enhance counseling support services.
- Conducted educational in-services for staff on women's issues to increase awareness and improve service delivery.
- Coordinated with Director of Education to develop and implement workshops on unplanned pregnancy for minors.
- Functioned as a field placement supervisor for the University of Pittsburgh, School of Social Work
Options Counselor
2 Months- Delivered pregnancy options counseling to women facing unplanned pregnancies, empowering them to make informed decisions.
- Facilitated counseling for significant others and parents regarding unplanned pregnancies, fostering supportive communication.
- Supported minors in securing judicial bypasses through Allegheny County Juvenile Court, ensuring access to necessary reproductive health services.
- Provided short term counseling for clients facing interpersonal issues.
- Provided counseling referrals for mental health evaluations.
- Maintained counseling notes and audited medical charts.
Research Assistant
1 Year 5 Months- Explained ongoing contraceptive studies to potential subjects; recruited study participants to enhance research engagement.
- Communicated with potential referral sources to facilitate awareness of current clinical trials and increase participant recruitment.
- Processed laboratory specimens for analysis in a clinical setting. and prepared shipments.
- Explain ongoing contraceptive studies to potential subjects; recruit potential study participants.
- Maintained source documents of subjects and completed case report forms to ensure data integrity and compliance.
- Performed phlebotomy on research subjects to collect blood samples. for clinical trials.
Part-time Instructor
8 Months- Instructed two courses: Introduction to Psychology and Human Growth and Development
- Planned lectures and curated educational materials to enhance student understanding.
- Distributed educational materials to students during lectures. and graded course examinations.
Education
Master of Arts - Psychology
Bachelor's Degree - Science
Associate Degree - Arts
Skills
Computer Experience MS Word
MS Excel
MS PowerPoint
Leadership
Instruction
Clinical trial management
TRAINING
- Collaborative Institutional Training Modules
- Coordination Orientation Course through University of Pittsburgh
- Good Research Practice through Human Research Protection Office (HRPO) University of Pittsburgh
Timeline
Research Operations Coordinator
Magee Women's Hospital of UPMC, Center for Family Planning Research
05.2018 - CurrentRead More
Research Principal Sr.
Magee Women's Hospital of UPMC, Center for Family Planning Research
03.2016 - 05.2018Read More
Research Study Coordinator
Magee Women's Hospital of UPMC, Center for Family Planning Research
08.2012 - 03.2016Read More
Clinical Research Associate
Magee Women's Hospital of UPMC, Center for Family Planning Research
10.2008 - 08.2012Read More
Senior Clinical Research Assistant
Magee Women's Hospital of UPMC
05.2007 - 10.2008Read More
Director of Counseling
Planned Parenthood/Women's Health Services of Western Pennsylvania
07.2004 - 02.2007Read More
Options Counselor
Planned Parenthood/Women's Health Services
05.2004 - 07.2004Read More
Research Assistant
Magee Women's Hospital of UPMC, Center for Family Planning Research
08.1999 - 01.2001Read More
Part-time Instructor
Community College of Beaver County
10.1998 - 06.1999Read More
Duquesne University
Master of Arts from Psychology
Read More
University of Pittsburgh
Bachelor's Degree from Science
Read More
Community College of Allegheny County
Associate Degree from Arts
Read More