Selina Koilraj

Detail-oriented Healthcare professional also trained as a Clinical Research personnel with a background in Neuroscience and Biotechnology. Good knowledge and understanding of ICH GCP guidelines, FDA Regulations, Data Management, Informed Consent Process, Clinical Trial Operations from start-up through close-out, ALCOA-C principles for good documentation standards, Monitoring and Query Resolution, Comprehension of Clinical Trial Protocols, Maintaining regulatory binder, DOA, Training Logs and other Investigator Site File (ISF) documents. Basic knowledge of patient recruitment, IVRS, EDC, source documents, and IP storage. Collecting vitals, blood pressure, weight, pulse, respiration rate of patients. Patient care. Maintaining communication with Industry Stakeholders. Can assist Phase II, III, and IV clinical trials administrative work. Fast learning capabilities.

• Good Clinical Practice GCP (NIDA)
• Transporting Dangerous Goods Training (IATA)
• Ethics and Human Subject Protection (ACRP)
• Good Clinical Practice Curriculum (CITI)
• FDA Clinical Investigator Training Course (CITC)
• Health Informatics Specialization (John Hopkins University)

• Coordinate patient recruitment and retention strategies, enhancing trial participation rates.
• Manage regulatory submissions and compliance documentation for studies.
• Schedule and conduct study visits with participants and investigators.
• Maintain accurate trial records and participant data, ensuring compliance with regulatory standards.
• Assist in developing study protocols and informed consent forms.
• Train new staff on clinical trial procedures and best practices.
• Communicate effectively with investigators, study staff, sponsors, vendors, CRAs of the trial.
• Maintain accurate tracking logs for clinical research activities, including adverse events, serious adverse events, concomitant medications, and lab results.
• Monitor patient safety during clinical trials, safeguarding participant well-being and adherence to established guidelines.
• Review CRFs for completeness and accuracy before database entry.
• Adhere to standards in areas involving data collection, research protocols, and regulatory reporting.
• Keep patient care protocols and clinical trial operations in compliance.
• Conduct routine visits to research sites to ensure compliance with protocol requirements.
• Review medical records for accuracy of source documentation.
• Develop and maintain accurate and timely study databases.
• Conduct screening interviews to determine eligibility of possible subjects.
• Perform vital sign assessments, ECG and record participant data during study visits.
• Educate participants on studies and anticipated outcomes.
• Monitor subject enrollment and tracked dropout details.
• Place orders for medications and kits to be used in studies.

• Participant recruitment
• Patient enrollment strategies
• Informed consent
• Clinical Protocol Compliance
• Regulatory compliance
• Clinical research ethics
• AE/SAE reporting, documentation, tracking
• Participant education
• Retention strategies
• Electronic data capture
• Investigational product management
• Investigator coordination
• Laboratory results management
• Records maintenance (logs)
• Scheduling proficiency
• Clinical practices, SOP understanding
• Medication dispensing
• Care coordination
• Teamwork