Kevin Rittenhouse
Arlington
Summary
Managed all aspects of clinical studies from site qualification to study close-out visits, adhering to Good Clinical Practices (GCPs) and relevant regulations. Maintained high standards for data quality and ensured timely submission, reporting, and follow-up on safety events by site personnel. Adept at site management, interim monitoring, and implementing Standard Operating Procedures (SOPs) to guarantee study integrity and compliance.
Overview
22
22
years of professional experience
Work History
Senior Clinical Research Associate
Worldwide Clinical Trials
09.2021 - Current
- Perform feasibility studies for potential sites as requested
- Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
- Function in the role of Lead CRA for global studies, coordinating CRAs
- Develop Clinical Monitoring Plan as requested
- Conduct site visit trip report review and provide feedback and edits
- Provide mentoring and guidance to less experienced CRAs and site staff when needed
- Design study specific tools and templates as requested
- Actively participate in study team and investigator meetings
- Actively participate in bid defenses
- Create and conduct training to study team members or colleagues as requested and appropriate
- Work with Project Management to evaluate deliverables and study milestones
- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
- Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
- Document site visit findings via written reports
- Provide input into the design of protocols and CRFs as requested
- Assess, monitor, and train study site staff on protocol adherence as required
- Review study subject safety information and informed consent
- Conduct source document verification for compliance, patient safety, and veracity of data
- Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
- Assist the site in maintenance of the Investigator Site File
- Maintain regular communication with sites
- Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
- Ensure site compliance with IP receipt, accountability and return or destruction
- Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
- Complete final site close out visit and report
Senior Clinical Research Associate
Insightec
01.2017 - 01.2018
- Monitored medical device trials utilizing Magnetic Resonance guided Focused Ultrasound studies for Alzheimer’s disease, essential tremors, Parkinson’s dyskinesia, blood-brain barrier disruption, intractable trigeminal neuropathic pain, and prostate cancer
- Acted as the primary point of contact for European study sites and managed sitelevel activities/communication to ensure project objectives, deliverables and timelines were met
- Monitored clinical device trials at research sites throughout Europe; and, performed backup monitoring and site management as needed in North America
- Conducted and documented site qualification, initiation, monitoring, and close-out visits
- Reviewed patient safety records and ensured complete documentation of subject safety events
- Reviewed regulatory binder to ensure complete, accurate, and up to date regulatory compliance at research sites
- Trained clinical site personnel on study procedures and provided training documentation
- Maintained a working knowledge of ICH/GCP Guidelines, FDA medical device regulations and European Union medical device regulations, as well as, other applicable guidance, and company SOPs/processes; completed assigned training as required
- Ensured the principal investigator was involved in the study along with Institutional Review Board oversight
- Raised issues of significance to the appropriate management level for resolution
- Helped sites navigate informed consent issues and Institutional Review Board approval process
- Assured consistency between Trial Master File and site regulatory files
- Understood project scope and timelines; utilized knowledge and experience to suggest improvements and/or innovations and pursued on-going systems improvements
- Provided mentoring/training to less experienced staff
Senior Clinical Research Associate
Gamma Therapeutics
05.2012 - 12.2015
- Monitored medical device studies to evaluate antibody testing to quantify a known cardiovascular disease risk associated protein and a cardiovascular surgical sealer
- Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance
- Performed on-site and remote monitoring visits
- Participated in the identification and selection of principal investigators and clinical study sites
- Performed site qualification, initiation, monitoring, and close-out visits at clinical study sites
- Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documentation as per company SOPs and Study Monitoring Plan
- Performed clinical site management activities (drive patient recruitment, source data verification, drug accountability, data collection, query resolution, and corrective actions)
- Provided protocol and therapeutic area related study training to clinical site personnel
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalated quality issues to Clinical Team Lead (CTL) and/or Line Manager (LM)
Clinical Research Associate
Contract
04.2011 - 04.2012
- Performed on-site monitoring visits and site management for virus (Rotavirus) vaccine study
- Administered protocol and related study training to assigned study site personnel
- Established regular lines of communication with sites to manage study expectations and issues
- Helped sites navigate informed consent issues and Institutional Review Board approval process
- Assured consistency between Trial Master File and site regulatory files
- Understood project scope and timelines; utilized knowledge and experience to suggest improvements and/or innovations and pursued on-going systems improvements
- Provided mentoring/training to less experienced staff
Senior Clinical Research Associate
Alcon Laboratories
10.2003 - 03.2011
- Monitored Ophthalmology, Otolaryngology, and CNS medical device and drug clinical trials
- Worked on clinical trials involving intra-ocular lenses, photo-refractive surgery, ocular surgery suite devices, anterior segment devices and pharmaceuticals, age related macular degeneration devices and pharmaceuticals, other various devices and pharmaceuticals
- Performed site qualification, pre-study, initiation, interim, and close-out study visits
- Engaged in on-site and remote monitoring to ensure compliance with company SOPs, GCP, ICH Guidelines
- Participated in the identification and selection of principal investigators and clinical study sites
- Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documentation as per company SOPs and Study Monitoring Plan
- Interpreted data to identify protocol deviations and risks to subject safety/data integrity
- Reviewed completion of proper informed consent procedures
- Ensured accurate data reporting via review of site source documents and study subject medical records
- Generated data queries and managed query resolutions with site personnel
- Monitored clinical studies at Ophthalmology clinics throughout the United States of America and at the Alcon on-campus eye clinic to ensure compliance with protocols and study objectives
- Coordinated shipment, accountability, and return of investigational product(s)
- Involved with clinical trial contracts and budget negotiations with clinical trial sites
- Performed site qualification, pre-study, initiation, interim, and close-out study visits
Education
PhD abd - Biomedical Science
Marshall University School of Medicine
Huntington, WV01.1998
Master of Science - Genetics
Texas A&M University
College Station, TX01.1996
Bachelor of Science - Biology
Texas A&M University
College Station, TX01.1990
Skills
- Genetics: Gene expression and gene silencing
- Cardiology: Cardiovascular disease risk protein antibody test; Surgical sealer with embedded clotting factors
- Central Nervous System (CNS): Alzheimer’s disease; Essential tremors; Parkinson’s dyskinesia; Blood-brain barrier disruption; Intractable trigeminal neuropathic facial pain
- Ophthalmology: Intraocular lenses, Age Related Macular Degeneration, Intraocular increased pressure, Wilson’s Disease, Intraocular Surgery Devices
- Otolaryngology: Rhinitis; Sinusitis
Phases: I, II, III, and IV
Therapeutic Areas:
- Pain Management: Neuropathic pain; Ablation instruments
- Obesity: Weight-loss medications; Vagal nerve blocks
- Medical Device: MRI guided focused ultrasound ablation; Cataract removal instruments; Intraocular lens development; Anterior segment surgical instruments; Ocular Cannulas; Metered spray bottles for drug delivery; Stent deliver device; Diagnostic blood tests
- Infectious Disease: Rotavirus vaccine
- Prostate Cancer: Ablation of adenocarcinoma with Gleason score from 6 – 8 without calcification
- Perform feasibility studies for potential sites as requested Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements Function in the role of Lead CRA for global studies, coordinating CRAs Develop Clinical Monitoring Plan as requested Conduct site visit trip report review and provide feedback and edits Provide mentoring and guidance to less experienced CRAs and site staff when needed Design study specific tools and templates as requested Actively participate in study team and investigator meetings Actively participate in bid defenses Create and conduct training to study team members or colleagues as requested and appropriate Work with Project Management to evaluate deliverables and study milestones Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (eg IRB / IEC study approval, informed consent, etc) Coordinate study material (eg CRFs, manuals) shipment and receipt by study site Document site visit findings via written reports Provide input into the design of protocols and CRFs as requested Assess, monitor, and train study site staff on protocol adherence as required Review study subject safety information and informed consent Conduct source document verification for compliance, patient safety, and veracity of data Review CRFs using paper or electronic data capture systems and assist sites with data query resolution Assist the site in maintenance of the Investigator Site File Maintain regular communication with sites Provide applicable updates for site related documentation for filing in the Trial Master File (TMF) Ensure site compliance with IP receipt, accountability and return or destruction Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate Complete final site close out visit and report Perform other duties as assigned The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
Responsibilities:
LANGUAGE SKILLS
English: Native
Timeline
Senior Clinical Research Associate
Worldwide Clinical Trials
09.2021 - Current
Senior Clinical Research Associate
Insightec
01.2017 - 01.2018
Senior Clinical Research Associate
Gamma Therapeutics
05.2012 - 12.2015
Clinical Research Associate
Contract
04.2011 - 04.2012
Senior Clinical Research Associate
Alcon Laboratories
10.2003 - 03.2011
Master of Science - Genetics
Texas A&M University
Bachelor of Science - Biology
Texas A&M University
PhD abd - Biomedical Science
Marshall University School of Medicine
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