Anita Severance
Ann Arbor,MI
Summary
Registered nurse and accomplished Senior Clinical Research Associate with more than 13 years experience with phase II-IV clinical trials, enhancing patient safety and study integrity through meticulous monitoring and risk management. Strong organizational and interpersonal communication skills. Reliable, energetic, adaptable and personable, with a strong work ethic. Significantly contributed to recruitment strategies and study compliance, ensuring project success with a blend of technical proficiency and effective communication.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
Fortrea
04.2020 - Current
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout study duration.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Played instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Monitored patient safety throughout clinical trials and reported any adverse events.
Clinical Research Associate II
IQVIA
01.2019 - 04.2020
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Supported successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of study process.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Monitored patient safety throughout clinical trials and reported any adverse events.
Clinical Research Nurse Coordinator
Michigan Head Pain and Neurological Institute
11.2011 - 01.2019
- Recruitment, screening, and monitoring of study subjects according to study specific protocols.
- Coordinating all aspects of studies including maintaining regulatory documents to coordinating and facilitating patient appointments.
- Completing all study required procedures such as obtaining informed consent, source documentation, ECGs, vital signs, dispensing/administration of investigational product, ensuring labs are collected, processed and shipped properly.
- Performing electronic data entry.
- Reporting Adverse Events and Serious Adverse Events.
- Preparing and submitting IRB reports.
- Procuring study supplies and materials
Clinic Registered Nurse
Michigan Head Pain and Neurological Institute
07.2007 - 11.2011
- Performed detailed assessments of clinic patients.
- Worked closely with Neurologists/Physicians to establish/maintain treatment plan for patients.
- Maintained accurate, detailed reports and records.
- Educated patients on disease, headache management and prescribed medications/treatments.
- Managed and completed Prior Authorization between patients and insurance companies. Monitored and maintained pharmaceutical medication samples for the Institute.
- Phone triage.
- Developed strong therapeutic relationships with patients through empathy, cultural sensitivity, and open communication channels that foster trust.
- Facilitated continuity of care by effectively communicating with primary healthcare providers regarding pertinent clinical findings and collaborating on optimal treatment strategies.
- Collaborated with interdisciplinary teams to develop individualized care plans that addressed physical, emotional, social, and spiritual needs of each patient.
- Promoted a safe and secure environment for patients, staff, and visitors by adhering to infection control protocols and maintaining an organized workspace.
Cardiac Stepdown Registered Nurse
University of Michigan Health System
02.2006 - 07.2007
- Handled a high volume of complex patients by prioritizing tasks and effectively delegating responsibilities to other team members, resulting in efficient patient care.
- Reduced complications post-surgery through diligent assessment, intervention, and timely communication with the interdisciplinary team.
- Served as an effective liaison between physicians, other healthcare providers, patients, and family members while coordinating optimal care planning efforts for each patient''s unique situation.
- Liaised with patients following cardiothoracic surgical procedures, providing support and education on post-surgical care.
- Collaborated closely with interdisciplinary healthcare teams during daily rounds for discussing patient cases and treatment plans that ensured continuity of care throughout hospital stays.
- Skillfully managed acute symptoms presented by patients experiencing chest pain or dysrhythmia, resulting in prompt medical intervention when necessary.
- Managed the administration of medication effectively, ensuring accurate dosages and preventing adverse reactions.
- Maintained detailed records of patient conditions, reactions and progress in alignment with physician orders.
- Changed dressings, cleaned wounds and monitored vital signs of up to multiple patients concurrently with focus on quality care.
- Educated patients about self-care at home following discharge from the hospital setting; increased adherence to treatment regimens which led to lower readmission rates.
- Enhanced patient recovery by providing specialized cardiac care and monitoring their progress.
- Ensured patient safety by strictly adhering to infection control protocols and maintaining a clean working environment.
- Maintained accurate and timely documentation of patient assessments, interventions, and outcomes in accordance with hospital policies and procedures; contributed to continuity of care across shifts.
- Evaluated patient histories, complaints, and current symptoms.
- Monitored patient reactions after administering medications and IV therapies.
- Managed patients recovering from medical or surgical procedures.
Education
Associate of Science - Nursing
Washtenaw Community College
Ann Arbor, MI12.2004
Skills
- Informed Consent Process
- Adverse event reporting
- Good Clinical Practices
- CRA Oncology Training
- Veeva Vault
- CTMS systems
- IWRS/IVRS systems
- Site Management
- Site monitoring expertise
- Electronic Data Capture Systems
- Patient recruitment
- Informed consent
- Study documentation mastery
- ICH-GCP guidelines
- Completing regulatory documents
Certification
- Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates.
Therapeutic Areas
- Neurological Disorders (Parkinson's, MS)
- Pain Disorders (Migraines, Myalgias, Neuropathies)
- Rheumatology/Autoimmune Disorders
- Cardiac
- Cancer (Solid Tumor)
- Ophthalmology
- Gene Therapy
Timeline
Senior Clinical Research Associate
Fortrea
04.2020 - Current
Clinical Research Associate II
IQVIA
01.2019 - 04.2020
Clinical Research Nurse Coordinator
Michigan Head Pain and Neurological Institute
11.2011 - 01.2019
Clinic Registered Nurse
Michigan Head Pain and Neurological Institute
07.2007 - 11.2011
Cardiac Stepdown Registered Nurse
University of Michigan Health System
02.2006 - 07.2007
- Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates.
Associate of Science - Nursing
Washtenaw Community College
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