Anita Subramanian
Jersey,NJ
Summary
Dynamic Senior Clinical Research Coordinator with extensive experience leading Phase 2 and 3 clinical trials in cardiovascular and rare diseases. Expertise spans the entire study lifecycle—from feasibility assessments and site start-up to database lock—while ensuring strict adherence to ICH GCP E6 (R2) and FDA regulations. Dual-certified professional skilled in advanced echocardiography diagnostics and clinical data management, consistently delivering high-quality research outcomes through effective protocol management and successful sponsor audits. Proven track record in enhancing team collaboration and optimizing patient interactions, ensuring accuracy and efficiency throughout clinical trial execution.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator II
Rutgers Robert Wood Johnson Medical School
New Brunswick
02.2024 - Current
- Oversee clinical operations within the Department of Cardiology and Hypertension.
- Execute intense Phase 2 and 3 trials with minimal assistance, managing both subject safety and regulatory compliance.
- Managing and executing intense Phase 3 trials and training junior co-ordinators.
- Clinical data management and subject recruitment and retention.
- Led coordination of clinical trials, ensuring compliance with regulatory standards and protocols.
- Developed and maintained study documentation, enhancing accuracy and consistency across projects.
- Trained and mentored junior staff on trial procedures and best practices for patient recruitment.
- Collaborated with multidisciplinary teams to streamline project timelines and improve operational efficiency.
- Analyzed data trends to inform strategic decisions regarding trial modifications and participant engagement strategies.
- Facilitated regular meetings with stakeholders to communicate progress, challenges, and solutions effectively.
- Implemented process improvements that reduced administrative burdens, allowing more focus on research objectives.
- Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Improved patient recruitment by developing and implementing targeted outreach strategies.
- Contributed to improved patient outcomes by providing valuable input on the development of new clinical trial protocols and methodologies.
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Coordinated with other departments such as biostatistics and regulatory affairs to streamline processes and ensure successful project completion.
- Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.
- Streamlined study processes for increased efficiency by collaborating with cross-functional teams on protocol development and implementation.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Developed robust data management plans for efficient data capture, analysis, and reporting throughout the study lifecycle.
- Enhanced data quality by closely monitoring study metrics and resolving discrepancies in a timely manner.
- Optimized patient safety during clinical trials by diligently monitoring adverse events and promptly escalating concerns when necessary.
- Reduced protocol deviations by providing comprehensive training and support to research staff.
- Increased patient retention rates by establishing strong relationships with participants through effective communication and followup.
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Gathered, processed, and shipped lab specimens.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
Clinical Research / Echocardiographer
247 Heart and Vascular
03.2021 - 02.2024
- Performed 2D Echo, M-mode, and Color Doppler to study pathologies for research data collection.
- Conducted data analysis and uploaded detailed study findings into e-clinical systems.
Echocardiographer
Penn Medicine & Princeton Medical Center
Princeton
03.2022 - 09.2022
- Utilized Epic EDC to document patient findings and manage clinical trial data.
- Performed 2D echos on inpatients and out patients.
Education
Medical Doctor (MD) - Homeopathic Medical Sciences
Maharashtra University of Health Sciences
India02.2010
Master’s Degree - Homeopathic Medicine
Maharashtra University of Health Sciences
IndiaDiploma - Cardiac Sonography-RCS
American Institute of Medical Sciences & Education
NJSkills
- Data Management (EDC): Medidata Rave, Oracle EDC, Axiom Portal, Webview, Clario, e-Clinical Systems
- Cardiovascular Diagnostics: 2D Echo, M-mode, Color Doppler, EKG, Stress Testing, Holter Monitoring, Cardiac Pathology Identification
- Regulatory & Compliance: ICH GCP E6 (R2), FDA 21CFR (11, 50, 54, 56), 45CFR46 (Common Rule), ALCOA-C Principles
- Clinical Systems: Epic EMR (including Epic EDC), e-Clinical, Microsoft Excel
- Trial Operations: Feasibility, SIV, Recruitment, Informed Consent, ISF/Regulatory Binder Management, AE/SAE Reporting
- Informed consent process
- Adverse event reporting
- Clinical trial management
- Clinical data management
- Clinical research ethics
- Patient recruitment
- Data collection
- Pharmacovigilance
- Study monitoring
- GCP training
- Good clinical practices
- Study protocols
- Research sops understanding
- Data collection techniques
- Site management
- Informed consent
- Specimen handling
- Medication dispensing
- Research experience
- Trial management
- Participant screening
- Schedule coordination
- Documentation management
- Report preparation
- Meeting coordination
- Good clinical practice
- Participant recruitment
- Database organization
- Teamwork and collaboration
- Problem-solving
- Time management
- Excellent communication
- Active listening
- Critical thinking
- Patient education
- Safety reporting
- Patient care coordination
Certification
- Clinical Research: Clinical Research Fastrack (Core Competencies & GCP).
- CITI Training: CRC Basic & Advanced, GCP (Social & Behavioral), Medical Devices.
- Technical: IATA (Dangerous Goods), PACE, Modified Rankin Scale Test.
- Clinical: Certified Echocardiographer (SPI), CPR/BLS Certified.
Languages
English
Professional Working
Hindi
Professional Working
Interests
- I enjoy helping others and giving back to the community
Timeline
Senior Clinical Research Coordinator II
Rutgers Robert Wood Johnson Medical School
02.2024 - Current
Echocardiographer
Penn Medicine & Princeton Medical Center
03.2022 - 09.2022
Clinical Research / Echocardiographer
247 Heart and Vascular
03.2021 - 02.2024
Diploma - Cardiac Sonography-RCS
American Institute of Medical Sciences & Education
Medical Doctor (MD) - Homeopathic Medical Sciences
Maharashtra University of Health Sciences
Master’s Degree - Homeopathic Medicine
Maharashtra University of Health Sciences