Ariel Kobylak
Wilmington,DE
Summary
Experienced in project management and passionate about clinical research, I possess a thorough understanding of clinical trial processes and regulatory standards. Skilled in data analysis and project coordination, I am equipped to excel in a Clinical Research Manager role. Ready to utilize and enhance my skills in clinical research and regulatory compliance, I strive for top-notch quality and efficiency in all projects.
Overview
16
16
years of professional experience
Work History
Clinical Research Manager, Hematologic Malignancies
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
10.2020 - Current
- Steer start-up, management, and budgeting of a varied portfolio of oncology clinical trials, from feasibility, qualification, and pre-site selection to long-term follow-up and close-out
- Demonstrates a commitment to ethical research by ensuring adherence to regulatory guidelines and institutional policies.
- Collaborates with cross-functional teams to design innovative approaches to complex research challenges.
- Fosters strong relationships with key stakeholders such as principal investigators, funding sources, and community partners.
- Experience with sponsored, NCTN and Investigator-initiated studies, Phases 1-3, including first-in-human
- The driver of growth – accelerated trial activation and expanded the overall number of studies, with year-over-year increases in female and minority enrollment.
- Supervise, train, and coach research staff onsite and remotely, including reviewing and assigning workloads and annual evaluations.
- Established effective monitoring systems to track progress and identify potential issues in ongoing clinical trials.
- Coordinates efforts among investigators, sponsors, and regulatory agencies to ensure seamless execution of clinical trials.
- Mentors junior staff members, guiding best practices in clinical research management.
- Fosters a culture of quality and accuracy, along with respect and support, with an eye on minimizing deviations.
- Spearhead interdepartmental collaboration for improved communication and resource sharing in clinical research projects.
- Adept at team- and relationship-building across disciplines, departments, and cultural boundaries
Clinical Research Coordinator III, Hematologic Malignancies
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
11.2017 - 10.2020
- Directed the technical, protocol-specific, and operational aspects of assigned studies by GCP, CFR, ICH and other applicable local and federal regulations
- Responsible for recruitment, informed consent, sample acquisition, data management, query resolution, and development of source documents
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Demonstrated tenacity in troubleshooting barriers to enrollment
- Praised by sponsors and CRAs for responsiveness, persistence and professionalism
- Identified discrepancies in consent forms and budgets, as well as logistical challenges of protocol requirements, allowing for proactive identification of solutions and process improvements
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Promoted to Team Lead February 2020
Clinical Research Project Manager
Children's Hospital of Philadelphia, Division of Gastroenterology, Hepatology, and Nutrition
09.2016 - 10.2017
- Responsible for the conduct of clinical research studies including recruitment, informed consent, sample acquisition and transport, data abstraction, source document development and database management
- Coordinated interaction between study participants, clinicians, lab personnel, data analysts and research coordinators while fostering dialogue geared towards efficiency and process improvements
- Provided training and guidance to support staff and work-study students
- Managed all IRB activities including initial submissions, continuing reviews, amendments, and adverse event reporting
- Maintained Investigator Site File
- Supervised the development of an online application providing research staff with direct access to study data, allowing for real-time analysis and the ability to leverage several existing data sources in one location
Lead Counselor II, Research Counselor Team
American Red Cross, Biomedical Services, Donor and Client Support Center
08.2009 - 09.2016
- Managed a caseload of over 70 blood donors participating in infectious disease research studies, in support of an IND application and in compliance with IRB, FDA, and institutional regulations and policies
- Identified and recruited eligible participants, maintaining high levels of retention through active engagement
- Assisted with development of study protocols and provided feedback during amendments
- Notified blood donors of reactive infectious disease test results including HIV, providing appropriate counseling, emotional support and connection to support services
- Performed quality reviews of team members' investigations to verify deadlines were met, and ensure cases were audit ready at all times
Education
Certified Clinical Research Professional -
Society of Clinical Research Professionals
Chalfont, PA04-2019
Bachelor of Arts - Psychology
Swarthmore College
Swarthmore, PA06.2002
Skills
- Adverse event reporting
- Hematologic malignancies
- Electronic data capture
- Investigator relations
- Training and mentoring
- Project planning
- Stakeholder communication
- Research activity tracking
- Detailed documentation
- Time management
- Attention to detail
- Leadership skills
- Excellent communication
- Teamwork and collaboration
- Clinical trial management
Timeline
Clinical Research Manager, Hematologic Malignancies
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
10.2020 - Current
Clinical Research Coordinator III, Hematologic Malignancies
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
11.2017 - 10.2020
Clinical Research Project Manager
Children's Hospital of Philadelphia, Division of Gastroenterology, Hepatology, and Nutrition
09.2016 - 10.2017
Lead Counselor II, Research Counselor Team
American Red Cross, Biomedical Services, Donor and Client Support Center
08.2009 - 09.2016
Bachelor of Arts - Psychology
Swarthmore College
Certified Clinical Research Professional -
Society of Clinical Research Professionals
Similar Profiles
Priya BalarPriya Balar
Senior Oncology Regulatory Coordinator at Thomas Jefferson University Sidney Kimmel CancerSenior Oncology Regulatory Coordinator at Thomas Jefferson University Sidney Kimmel Cancer
Nicole BassounasNicole Bassounas
Nurse Practitioner at Thomas Jefferson-Sidney Kimmel Cancer CenterNurse Practitioner at Thomas Jefferson-Sidney Kimmel Cancer Center
Muzzammil ShaikMuzzammil Shaik
Research Assistant at Sidney Kimmel Cancer CenterResearch Assistant at Sidney Kimmel Cancer Center