Marlene Serrano

• Sourced potential subjects by conducting screening interviews, reviewing medical records, and consulting with healthcare professionals
• Collaborated with investigators on presentations and reports detailing clinical study procedures, results, and conclusions.
• Managed procurement of required drugs and devices for successful study execution
• Oversaw subject enrollment to ensure that informed consent is properly obtained and documented.
• Organized and arranged site visits while maintaining effective communication with sponsors.
• Maintained records of study activity, including case report forms, drug dispensation records, and regulatory forms.
• Engaged in ongoing professional development through participation in continuing education activities, conferences, and seminars to stay updated on clinical studies aspects and concerns.
• Prepared various study-related documents including protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Documented subject enrollment status and kept track of reasons for dropout, along with monitoring subject communication

Coordinated multiple aspects of specimen handling to ensure timely delivery

• Verified study activities compliance with protocols.
• Compiled trial related documents into a master file as required by sponsor or regulatory agency.
• Assisted in preparing periodic reports summarizing progress of clinical studies.
• Developed and maintained accurate and timely study databases.
• Monitored patient safety during clinical trials according to established guidelines.
• Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
• Performed patient assessments, collected and analyzed data, and prepared reports.
• Assisted in the preparation of Institutional Review Board submissions for clinical trials.
• Conducted routine visits to research sites to ensure compliance with protocol requirements.
• Coordinated investigator meetings, conference calls, and site initiation visits as needed.

• Assessed eligibility of potential subjects through methods such as screening interviews, reviews of medical records and discussions with physicians and nurses
• Conferred with healthcare professionals to determine best recruitment practices for studies
• Performed specific protocol procedures such as interviewing subjects, taking vital signs and performing electrocardiograms
• Organized space for study equipment and supplies
• Informed patients and caregivers about study aspects and outcomes to be expected
• Instructed research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures
• Communicated with laboratories and investigators regarding laboratory findings
• Scheduled subjects for appointments, procedures, and inpatient stays as required by study protocols
• Participated in continuing education activities, and attended conferences and seminars to maintain current knowledge of clinical studies affairs and issues
• Monitored study activities to verify compliance with protocols and with relevant local, federal and state regulatory and institutional policies
• Maintained required records of study activity including case report forms, drug dispensation records, and regulatory forms
• Oversaw subject enrollment to ensure that informed consent is properly obtained and documented
• Tracked enrollment status of subjects and documented dropout information causes and subject contact efforts
• Evaluated and interpreted collected study data
• Prepared study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports
• Dispensed medical devices and drugs and calculated dosages and provide instructions as necessary.

• Coordinated with treatment center personnel to obtain patients' vital statistics and medical history, to determine circumstances of emergency, and to administer emergency treatment
• Assessed nature and extent of illness and injury to establish and prioritize medical procedures
• Operated equipment, such as electrocardiograms (EKGs), external defibrillators, and bag valve mask resuscitators, in advanced life support environments
• Observed, record and report to physician patient's condition and injury, treatment provided and reactions to drugs and treatment.

• Administered first aid and cardiopulmonary resuscitation to injured persons and provided emergency medical care such as basic and advanced life support
• Assessed nature and extent of illness and injury to establish and prioritize medical procedures
• Coordinated with treatment center personnel to obtain patients' vital statistics and medical history, to determine circumstances of emergency, and to administer emergency treatment
• Administered drugs, orally and by injection, and performed intravenous procedures
• Operated equipment, such as electrocardiograms (EKGs), external defibrillators, and bag valve mask resuscitators, in advanced life support environments
• Performed emergency cardiac care, such as cardioversion and manual defibrillation.