Clinical Research Regulatory Manager resume example with 9+ years of experience
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Dedicated healthcare professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Experienced healthcare professional with over 7 years of experience in clinical research. Excellent reputation for resolving problems and improving customer satisfaction.
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- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Liaised with 18 hospitals department personnel to communicate important clinical data and events.
- Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
- Onboarded new employees with training and new hire documentation.
- Accomplished multiple tasks within established timeframes.
- Evaluated employees' strengths and assigned tasks based upon experience and training.
- Reduced process bottlenecks by training and coaching employees on practices, procedures and performance strategies.
- Performed statistical analyses to gather data for operational and forecast team needs.
- Maximized performance by monitoring daily activities and mentoring team members.
- Cross-trained existing employees to maximize team agility and performance.
- Delivered feedback to decision-makers regarding employee performance and training needs.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Screened 100 patient records, databases and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes and maintained records.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Gathered, processed and shipped lab specimens.
- Proved successful working within tight deadlines and fast-paced atmosphere.
- Exceeded goals through effective task prioritization and great work ethic.
- Resolved problems, improved operations and provided exceptional service.
- Increased referral rates by 10 % providing excellent service and building meaningful relationships with patients and caregivers.
- Participated in professional growth programs to support special education improvement efforts.
- Identified care needs of individual patients and coordinated responses based on physician advice, insurance limitations and procedural costs.
- Facilitated special education placement process in partnership with parents to provide free appropriate public education for eligible referrals.
- Evaluated IEP for compliance with state and federal requirements regulations and rectified non-compliance issues immediately.
- Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
- Prepared and presented comprehensive reports to upper management and audit team, covering issues and recommendations.
- Played instrumental role in company-wide risk assessment efforts, supporting enhancements in business processes and controls.
- Reviewed documents, files, transcripts and other records to assess compliance and potential risk.
Kappa Delta Pi International Honor Society
Omega Lambda Nu National Honor Society
Psi Chi International Honor Society
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Resume Overview
School Attended
- Quantic Valar Institute
- Liberty University
- Virginia Lynchburg University
- Walden University
Job Titles Held:
- Clinical Research Regulatory Manager
- Project Manager
- Case Manager Supervisor
Degrees
- MBA
- Master of Science
- Doctorate
- Master of Science
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