Hephzibah Roxane S

Clinical Operations and Site Management | Participant Management | Documentation and Data Management | Cross-functional Collaboration | Operational Support

• Managed end-to-end site operations while ensuring strict adherence to ICH-GCP, protocol requirements, and regulatory standards.
• Supported subject screening, informed consent, visit coordination, safety documentation, and maintenance of high-quality source data.
• Ensured timely and accurate EDC/CRF entry, and reviewed CRFs for completeness and accuracy before database submission.
• Maintained the Investigator Site File, ensured audit and monitoring readiness, and handled IP accountability throughout the study.
• Conducted routine visits to research sites to verify compliance with protocol requirements.
• Kept patient care protocols and clinical trial processes compliant with regulatory and institutional guidelines.
• Coordinated participant recruitment for clinical trials and research studies.
• Assessed patient records, reviewed databases, and checked referrals to identify eligible study participants.
• Scheduled and conducted participant interviews, study visits, and follow-up appointments.
• Monitored patient safety during clinical trials according to established guidelines.
• Collected, processed, and delivered specimens from trial participants.
• Performed patient assessments, collected data, analyzed findings, and prepared reports.
• Managed study documentation and ensured compliance with regulatory and protocol standards.
• Developed and maintained accurate and timely study databases.
• Assisted with data collection, entry, cleaning, and preliminary analysis for ongoing studies.
• Maintained up-to-date tracking logs for adverse events, serious adverse events, concomitant medications, and lab results.
• Developed case report forms for data collection at investigational sites.
• Collaborated closely with investigators, CRAs, sponsors, and internal departments, including Regulatory Affairs and Data Management.
• Worked with research teams to develop study protocols, timelines, and operational plans.
• Communicated study progress, updates, and findings to stakeholders throughout the trial lifecycle.
• Provided guidance on Good Clinical Practice, and other applicable regulatory standards.
• Organized training sessions for new staff on study procedures, protocols, and compliance requirements.
• Maintained an inventory of study supplies and equipment needed for research activities.
• Ensured research workflows, documentation, and regulatory reporting met institutional and sponsor expectations.
• Supported audit, monitoring, and site compliance activities through organized systems and timely documentation.

Clinical Pharmacy & Medication Management | Patient Education and Counseling | Pharmacovigilance & Medication Safety | Clinical Research & Pharmacology | Administrative and Professional Development

• Conducted literature reviews on medication interventions, dose adjustments, and patient counseling approaches.
• Reviewed case sheets and medication charts to evaluate the appropriateness of therapy.
• Participated in clinical rounds to provide pharmacotherapy recommendations.
• Reviewed patient medication profiles for potential interactions, contraindications, and allergies.
• Conducted medication reconciliation during admissions and discharges, resolving discrepancies between home and inpatient medications.
• Reviewed new prescription orders for accuracy, appropriateness of dose, route, frequency, formulary status, and cost-effectiveness.
• Reviewed laboratory results, and monitored patient progress toward therapeutic goals.
• Monitored patient outcomes to evaluate the effectiveness of therapeutic interventions.
• Identified opportunities to improve prescribing practices through utilization review activities.
• Collaborated with physicians, nurses, and healthcare teams to optimize medication management strategies and therapeutic outcomes.
• Provided patient counseling on medication use, adherence, and safety.
• Educated patients on proper medication administration techniques.
• Assisted in developing patient education materials on medication use.
• Provided guidance to patients and caregivers on the prescription refill process.
• Performed pharmacovigilance activities, including detection, assessment, monitoring, and reporting of adverse drug reactions (ADRs).
• Conducted drug interaction monitoring, and identified medication errors.
• Trained in Case Processing under reference training from Prema Krishna, MD., Global PvG/Drug and Device Safety, President – Planet Konsultants.
• Developed educational materials on medication safety topics.
• Maintained updated knowledge on new drug releases and changes to existing drug information.
• Worked in core pharmacology areas, including infectious diseases.
• Applied Good Clinical Practice (GCP) principles in medication report writing and clinical research tasks.
• Contributed to documentation and reporting, supporting clinical study requirements.
• Prepared monthly reports summarizing clinical interventions by the pharmacy team.
• Attended weekly staff meetings with pharmacists, and interdisciplinary teams.
• Participated in continuing education programs to stay current with evolving treatment options and therapeutic guidelines.