Hi, I’m
RUDOLF MALLE
Queens Village,NY
Summary
Proficient, Competent and Detail-oriented Clinical Research Professional with multiple years of experience skilled at performing and coordinating all aspects of the SQV, IMV (in-person/remote), COV and site management process following applicable regulatory guidelines. Highly efficient central lab setup subject matter expert within a fast-pace high pressure time sensitive environment. Highly experienced working on first-in-human studies and phases 1 - 3 Oncology, Endocrinology, GI, and Cardiology drug studies to evaluate medical, surgical, and behavioral interventions. Provides one-on-one and group clinical research training to high-level career switchers.
Overview
8
years of professional experience
1
Certification
Work History
ICON LaboratoriesFarmingdale, NY
Lab Setup Project Manager [Remote]
09.2021 - Current
Job overview
- Serves as the primary liaison with the sponsor during the setup phase of the study.
- Lead projects in respect to setup process improvement and serve as a member for other projects utilizing subject matter expertise.
- Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.
- Serves as the subject matter expert for the Sponsor in guiding them through a successful setup process by drawing on past experiences and standards.
- Conducts high levels risks assessment associated with the study to the sponsor and internal parties including participating in internal risk assessment and other operational meetings as necessary.
- Works independently, coordinate and manage the completion of the Client Laboratory Worksheet (CLW) and communication of information as required to the other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).
The Coursebar Clinical Research AcademyHyattsville, MD
Trainer & Founder [Remote]
12.2021 - Current
Job overview
- Develop industry based content and curriculum based of graduate-level context for professionals.
- Provides one-on-one coaching style training to switching professionals into the field of Clinical Research
- Provides small group training - workshop style via Weekly weekend webinars
- Demonstrated knowledge of technical procedures and proper equipment use.
- Stayed current with innovations in the clinical research industry.
Weill Cornell Medical CollegeNew York, NY
Clinical Research Associate
01.2019 - 09.2021
Job overview
- Managed over 90 studies across Lymphoma, Multiple Myeloma, Leukemia, GI and Thoracic cancer studies within the IRB system
- Hired and trained six clinical research coordinators.
- Traveled to study sites to conduct SQV, IMV and COVs
- Managed and trained my team on the use of EDC, IVRS, and CTMS systems.
- Coordinated and conducted bi-weekly meetings with multiple teams to address enrollment, start-up updates, budget, and contract modalities and timelines.
- Creates, reviews, and customizes site-specific docs, including ICFs, and follows up with sites and sponsors accordingly.
- Creates site SOPs to meet sponsor standards for site selection
- Reviews and submits internal and external SAEs and SUSAR reports to the IRB according to SOP and IRB reporting policies.
Medpace Reference Laboratories (CRO)/ContractedNew York, NY
Clinical Research Associate[Part Time]
06.2018 - 01.2019
Job overview
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Maintained and utilized clinical systems such IVRS, eTMF, CTMS in study management
- Gathered and organized clinical trial documentation to meet rigorous standards for initial site approval.
- Traveled to investigative four sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
- Reviewed data queries and listings and worked with site coordinators to resolve data discrepancies.
Weill Cornell MedicineManhattan, NY
Senior Clinical Research Coordinator
03.2017 - 06.2018
Job overview
- Screened patient records, EMRs, and physician referrals to identify potential subjects for research studies.
- Coordinated subject visits, calendar, procedures for multi-visit studies
- Collected, processed, and shipped subject laboratory specimens per protocol.
- Coordinated monitoring site visits, inspections, and audits and provided timely responses to queries.
Laurelton Heart Specialist, PC Queens, NY
Clinical Research Coordinator
10.2015 - 03.2017
Job overview
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Collected, evaluated, and modeled collected data
Education
Drexel University, Philadelphia, PA
Master of Science from Clinical Research Organization And Management
05.2020
Sollers, Edison, NJ
Certificate from Clinical Research Management
06.2017
University Overview
- Executive Member of Sollers Pioneer Student Association
- Graduated in Top 5% of Class
- Dean's List 2017
Allen School - Jamaica, Jamaica, NY
Certified Medical Assistant from Medical Assisting
12.2016
University Overview
- Graduated summa cum laude
University Of Buea, Cameroon
Bachelor of Science from Business Management
07.2013
Skills
- Knowledge of GCP and Federal Regulations
- Audit preparedness
- Report writing
- Risk-Based Monitoring
- Employee training
- Pre-study visits
- Critical Thinking
- Remote Monitoring Visits and Protecting PHI
- Safety monitoring and oversight
- Exceptional Monitoring Report
- Writing Effective Data Queries
- Coordinating site operations
- Timely Project Completion
- Workflow Planning
- Managing Multiple Projects
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