MELANIE RUSSOW
Belmont
Summary
Dedicated CRA and Registered Nurse with 15+ years clinical nursing experience and 14 years of Clinical Research experience. Proficient in monitoring multiple therapeutic areas. Ability to meet deadlines while ensuring the integrity of study data is in accordance with the protocol and standard operating procedures. Goal-driven health professional with high assimilation of new ideas and strategies for solving problems.
Overview
1
1
Certification
35
35
years of professional experience
Work History
CRA II
SYNEOS
06.2023 - Current
- Conduct site monitoring visits and co-monitoring visits in person and remote to assess protocol adherence, Source verification, and ensure compliance with regulatory requirements.
- Report writing and completion within required SOP and local regulatory parameters.
- Consistent and timely communication with assigned clinical sites, investigators to address study needs related to monitoring and site management.
- Participate in site selection process to ensure adequate qualifications, resources, and training for sites.
- Support monitoring of PSV, SIV, IMV, COV's for Ph1- ph4 clinical trials.
- Review and report site enrollment, protocol deviations, AEs, SAEs, laboratory abnormalities per protocol and regulatory requirement.
- Verify IP accountability, reconciliation, return and verify storage requirements.
- Maintain and reconcile TMF.
CRA I
LABCORP/FORTREA
11.2022 - 06.2023
- Successfully Completed MEA program.
- Independently Conducted site PSVs, SIVs, IMVs, COV's for ph2a-Ph 4 clinical trials.
- Closely monitored activities at clinical sites toensure successful execution of studies according to study protocols.
- Maintenance and reconciliation of Trial Master File.
- Primary Point of contact for study site personal to answer questions and resolve study related issues.
- Monitor collection, accuracy, and integrity of regulatory documents in site ISF.
Study coordinator/Research nurse
ATRIUM: (formerly Carolina’s Medical Center)
09.2022 - 09.2023
- Coordinated clinical study activities to ensure compliance with regulatory requirements and protocols.
- Oversaw data collection processes, ensuring accuracy and integrity of research findings.
- Implemented process improvements that streamlined workflows and increased operational efficiency in studies.
- Collaborated with multidisciplinary teams to address challenges and optimize research outcomes.
- Streamlined communication between participants and research team, fostering effective collaboration and data collection.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- 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.
- 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.
- Supported participant retention efforts by designing engaging materials that highlighted the benefits of continued involvement in the study.
- Promoted a culture of continuous improvement within the research team through constructive feedback on study processes and outcomes.
- Ensured regulatory compliance by meticulously maintaining documentation for study activities.
Study coordinator/Research nurse
INTRAFUSION RESEARCH
07.2013 - 08.2021
- Managed participant recruitment efforts, enhancing enrollment through targeted outreach strategies.
- Trained and mentored junior staff on study procedures and best practices in clinical research.
- Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
- Mitigated risks to study integrity through vigilant monitoring of protocol adherence and prompt resolution of any deviations.
- Contributed to a positive work environment by fostering open communication, teamwork, and professional development opportunities for staff members.
- Reduced study attrition rates by proactively addressing participant concerns and providing ongoing support.
- Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- 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.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Educated family members and caregivers on patient care instructions.
Intrafusion Nurse Mgr
INTRAFUSION OIC
01.2012 - 03.2015
- managed Infusion center for IVIG, Tysabri, solumedrol, and migraine “cocktails”.
- Mentored and trained nursing team members, fostering professional growth and skill development.
- Managed resource allocation, balancing budgetary constraints with quality patient care needs.
- Developed and implemented quality improvement initiatives to provide best possible patient care and identify and address areas of concern.
- Served as a key point of contact between nursing staff, physicians, administration, and other healthcare professionals.
- Monitored clinical outcomes closely, identifying areas for improvement and implementing corrective actions.
- Established strong relationships with patients'' families, providing support and education throughout the treatment process.
- Explained course of care and medication side effects to patients and caregivers in easy-to-understand terms.
PRN Clinical Educator
CR BARD- Covington, Ga
10.2008 - 10.2013
- Formal/informal presentations for Implementation, Maintenance education and follow up on product accounts, expense report, and communication with supervisors/educators.
- Developed and implemented educational programs for clinical staff on product usage and best practices.
- Facilitated training sessions to enhance knowledge of medical devices and compliance standards.
- Provided customized training materials tailored to the specific needs of individual healthcare facilities.
- Enhanced staff proficiency in clinical procedures through hands-on demonstrations and interactive workshops.
- Served as a clinical mentor, offering guidance and support to employees.
PRN Staff Nurse, PACU
CAROLINAS MEDICAL CTR - Pineville, NC
11.2003 - 01.2011
- Pre-op, post op phase 1 and phase 2 care of inpatient and outpatient pediatric through geriatric patients.
- Administered medications and monitored patient vital signs to ensure optimal health outcomes.
- Educated patients and families on treatment options and post-discharge care instructions, enhancing understanding and compliance.
- Conducted thorough assessments of patient conditions, identifying changes that required immediate intervention.
- Improved patient satisfaction scores by actively listening to concerns, addressing needs promptly, and providing emotional support during difficult times.
- Served as a mentor to new nursing staff, fostering a positive learning environment and sharing best practices for optimal patient care.
- Coordinated seamless transitions of care between various departments within the hospital setting by effectively communicating relevant information among healthcare providers.
- Provided high-quality patient education on post op care, empowering individuals to care for themselves to ensure good surgical outcomes.
- Continuously expanded professional knowledge through participation in continuing education courses, workshops, conferences, and other learning opportunities related to nursing practice improvements.
- Utilized critical thinking skills to prioritize tasks effectively during high-stress situations while maintaining exceptional levels of patient care.
- Demonstrated proficiency in various nursing techniques including IV insertion, catheterization, wound care, and medication administration.
- Managed patients recovering from medical or surgical procedures.
- Managed time efficiently by delegating tasks appropriately and utilizing available resources to ensure optimal patient care delivery.
- Promoted a healing environment for patients and families through compassionate care and effective pain management strategies.
- Monitored patients' conditions and reported changes in physical presentation, appearance, and behavior to discuss treatment with physicians.
- Educated patients, families and caregivers on diagnosis and prognosis, treatment options, disease process, and management and lifestyle options.
- Implemented medication and IV administration, catheter insertion, and airway management.
- Coordinated patient discharge planning to provide post-discharge patient care, promoting healing and recovery.
- Evaluated patient histories, complaints, and current symptoms.
PRN float nurse ICU
HARRIS METHODIST HOSPITAL - HEB Bedford, Tx
10.1997 - 07.1999
- Primary care of hemodynamically unstable patients in complex ICU setting-from fresh surgical patients direct from OR ventilated and with multiple drips- including fresh CABG, fem-pop, amputations, craniotomies, traumas, etc.
- Inpatient care of patients with multi-system failure due to sepsis, shock, renal failure, DIC, MI, CVA, trauma, etc.
- Management: chest tubes, central lines, swan ganz line, PICC lines, hemodynamic drips, blood administration, blood and arterial blood gas collection.
- Collaborated with multidisciplinary teams to develop and implement individualized care plans.
- Administered medications and treatments as prescribed by physicians.
- Provided skilled, timely and level-headed emergency response to critically-ill patients.
- Delivered high level of quality care to diverse populations while overseeing patient admission and triaging based on acuity and appropriate department admission.
- Promoted patient and family comfort during challenging recoveries to enhance healing and eliminate non-compliance problems.
- Performed frequent checks on life support equipment and made necessary adjustments to preserve optimal patient conditions.
- Managed patients recovering from medical or surgical procedures.
PRN float nurse ICU/CCU
ARLINGTON MEMORIAL, Arlington, TX
10.1997 - 01.1999
- Primary care of hemodynamically unstable patients in complex ICU setting-from fresh surgical patients direct from OR ventilated and with multiple drips- including fresh CABG, fem-pop, amputations, craniotomies, traumas, etc.
- Inpatient care of patients with multi-system failure due to sepsis, shock, renal failure, DIC, MI, CVA, trauma, etc.
- Management: chest tubes, central lines, swan ganz line, PICC lines, hemodynamic drips, blood administration, blood and arterial blood gas collection.
- Educated patients and families on treatment processes, improving understanding of conditions and care options.
- Trained new nursing staff on operational procedures, enhancing team efficiency and skill level.
- Implemented infection control measures, ensuring compliance with health regulations and safeguarding patient safety.
- Managed time effectively to balance competing priorities in high-pressure situations across multiple units.
- Delivered high-quality nursing care to diverse patient populations in various clinical settings and departments.
- Administered and maintained comfort, treatment, medication, intravenous infusion and health care to support patient needs.
- Provided compassionate end-of-life care, prioritizing comfort and dignity for both patients and their families.
- Conducted rounds with medical staff to promote improved understanding between patients, nursing staff and medical staff to support continued quality of communication and care.
- Submitted accurate documentation, reporting and in-depth nursing observation to support continuity of total patient care.
PRN RN-ER/ICU
Highlands Regional Medical Center Sebring, Fl
01.1996 - 01.1997
- Triage / Assist MD with procedures. Sutures, staples, dressings.. Management of hemodynamically challenged ICU patients-performed ecgs, IV mgmt, swan lines, hemodynamic drips, post endarterectomy patients.
RN 1995-1997 ICU/SICU
LAKELAND REGIONAL MEDICAL CTR -Lakeland, Fl
01.1992 - 01.1997
- (1992-1997 Staff Nurse)
- (LPN 1992-1995 PCU/CIU)
- Evaluated patient progress through thorough assessments, adjusting care plans as necessary to optimize outcomes.
- Utilized critical thinking skills to prioritize nursing interventions based on patients'' acuity levels and individual needs.
- Conducted thorough patient assessments to identify changes in condition, promptly notifying physicians and initiating appropriate interventions when necessary.
- Administered medications safely according to established guidelines while closely monitoring for side effects or adverse reactions requiring intervention.
- Prevented the spread of infections by consistently adhering to strict infection control protocols and educating patients on proper hygiene practices.
- Participated in ongoing professional development opportunities to stay current on best practices in nursing care and emerging trends in healthcare delivery.
- Advised patients and caregivers of proper wound management, discharge plan objectives, safe medication use, and disease management.
- Documented treatments delivered, medications and IVs administered, discharge instructions, and follow-up care.
- Communicated with healthcare team members to plan, implement and enhance treatment strategies.
- Monitored patient reactions after administering medications and IV therapies.
- Explained course of care and medication side effects to patients and caregivers in easy-to-understand terms.
- Provided skilled, timely and level-headed emergency response to critically-ill patients.
- Promoted patient and family comfort during challenging recoveries to enhance healing and eliminate non-compliance problems.
Education
ASN - nursing
University of NY-Regents College
Albany, NY01-1995
Skills
- 45 yrs of Clinical Research Monitoring experience
- 9 years pf Clinical Research Coordinator experience
- Extensive knowledge of medical equipment, products, and pharmaceuticals
- Proficient with EDC (Medidata, Oracle, Vault, Encapsia)
- Proficient with eTMF (Florence, Veeva, Realtime, Complion
- Proficient with IXRS (Endpoint, 4G, Suvoda, Medidata RTSM)
- Central Vendor experience ( Quintiles, Clario, PPD, Q2, Labconnect, Labcorp, Medavante, Alma’s, Trifecta, Advarra, WCG
THERAPEUTICS
CNS: Essential tremors- Ph2 , Parkinson’s- Ph2, Parkinsons- Ph3, SMA-Ph3, Dementia-2a, Multiple Sclerosis-Ph2, Multiple Sclerosis- Ph3, Multiple Sclerosis- Ph4, Restless Leg- Ph2, Dementia-Ph3. Alzheimer’s Dementia- Ph2, Muscle spasticity-Ph3.
Respiratory: Bronchiolitis obliterans-ph2.
Rare Disease: SMA-Ph3
Infectious Disease: HIV associated disorders-Ph3, Covid-19-Ph2.
Cardiovascular: HFPEF-Ph3, Hypertrophic Cardiomyopathy-Ph3, Hypertension-Ph3.
Vaccines: Covid 19-Ph2, Peanut allergy-Ph1.
Endocrine: Diabetes Mellitus-Ph2, Pituitary disorders-Ph3.
Renal: NASH-Ph3, kidney disease-Ph3,
skills
- Knowledge of Electronic Data capturing Systems, CTMS, eTMF, IXRS and ability to learn appropriate software.
- Excellent knowledge and understanding of ICH/ GCP guidelines.
- Strong attention to detail.
- Strong understanding of medical /therapeutic knowledge and medical terminology.
- Strong understanding of medical /therapeutic knowledge and medical terminology
- Ability to work in group setting, or independently and adjust to changing priorities.
Certification
RN NC license 173526 exp 31Aug2026
Timeline
CRA II
SYNEOS
06.2023 - Current
CRA I
LABCORP/FORTREA
11.2022 - 06.2023
Study coordinator/Research nurse
ATRIUM: (formerly Carolina’s Medical Center)
09.2022 - 09.2023
Study coordinator/Research nurse
INTRAFUSION RESEARCH
07.2013 - 08.2021
Intrafusion Nurse Mgr
INTRAFUSION OIC
01.2012 - 03.2015
PRN Clinical Educator
CR BARD- Covington, Ga
10.2008 - 10.2013
PRN Staff Nurse, PACU
CAROLINAS MEDICAL CTR - Pineville, NC
11.2003 - 01.2011
PRN float nurse ICU
HARRIS METHODIST HOSPITAL - HEB Bedford, Tx
10.1997 - 07.1999
PRN float nurse ICU/CCU
ARLINGTON MEMORIAL, Arlington, TX
10.1997 - 01.1999
PRN RN-ER/ICU
Highlands Regional Medical Center Sebring, Fl
01.1996 - 01.1997
RN 1995-1997 ICU/SICU
LAKELAND REGIONAL MEDICAL CTR -Lakeland, Fl
01.1992 - 01.1997
ASN - nursing
University of NY-Regents College