Clinical Research Associate
Resume:
Terrance “Terry” Ott
757-***-**** ad5mzd@r.postjobfree.com Virginia Beach, VA
Norfolk, Va 23503
Therapeutic Experience
Immune Mediated Inflammatory Disease (IMID): Systemic IMID – Lupus, Inflammatory Respiratory - COPD
CardioMetabolic: Metabolic and Cardiovascular Risk – Type II Diabetes, Cardiovascular Disease – Peripheral Artery Disease, PAD, PAOD, Diabetic nephropathy, renal vascular disease
NeuroScience: Rare Disorders – Other Rare Disorder
Infectious Disease: Anti-Viral Therapy, Influenza, CMV, HPV
Oncology: Hematologic Malignancies – Other hematologic malignancies
Other: Hematology – Other Anemia, Platelet Disorders/ITP, Ophthalmology – Macular Degeneration; retinal bleeding, thickening, neovascularization, Glaucoma, Dry Eye and conjunctival syndromes, Other ophthalmology Alports
Orphan: Alports
Devices:
Diagnostic procedure/device evaluation Lycox O2 brain monitoring
Portable TBIs monitoring for Brain Trauma in War
CSF trauma systems
Brain Monitoring for Battle injuries
Collagen
Wound healing
Ulcers venous
Diabetic ulcers
Use in spine
Peridural fibrosis
Anti adhesion. Use with BMP bone morphogenetic protean (partner with Medtronic)
Employment History
Chiltern, (now Covance, Inc.) Cary, NC, USA – Oct. 2017 – Present
Senior Clinical Research Associate
Perform and coordinate assigned aspects of the clinical monitoring process in accordance with ICH/GCP standards and SOPs to assess the safety and efficacy of the investigational product.
Develop collaborative relationships with investigative sites, study vendors, internal team members and client company personnel
Conducted SDV according to Study Monitoring Plan, IP Accountability and Site Regulatory/Essential document review.
Participated in regularly scheduled Study team calls to remain informed on current study directives and issues.
Acted as the primary contact for individual investigative sites throughout the clinical trial.
Mentored and trained newer CRAs and site staff throughout the trial process.
Trial Runners, Inc.
Regional Sr. CRA – Aril 2016 to Sept. 2017
Acted in the capacity of a Site Manager/CRA ensuring relationship with site(s) are positive, issues
are resolved quickly, and communications are strong across all verticals.
Provided training to sites on the study protocol, study conduct, CRF completion and data
management expectations.
Ensured essential document compliance and collection for regulatory requirements/TMF.
Served as a primary liaison with Investigators, Institutions and sites to provide support during the
conduct of the clinical trial and serve as a resource for protocol and procedures.
Provided on-site monitoring, Souce Data Verification, IP Accountability to ensure compliance with GCPs, SOPs, Study Protocol and Monitoring plan.
Managew study completion activities including CRF collection, query resolution, record
archiving and site closeout activities
Therapeutic Areas
Alports Syndrome
Ophthalmology
Keryx Biopharmaceuticals, NYC, NY, USA – Jul. 2012 – Sep. 2016
Senior Clinical Research Associate
Acted in the capacity of a Site Manager ensuring relationship with site(s) are positive, issues are resolved quickly and communications are strong across all verticals
Provided training to sites on the study protocol, study conduct, CRF completion and data management expectations
Ensured essential document collection for completeness per regulatory requirements
Served as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures
Demonstrated knowledge of on-site monitoring to ensure compliance with GCPs, study protocols and SOPs
Assisted Project Manager in tracking/managing study supplies
Monitored product supplies/drug accountability
Managed study completion activities including CRF collection, query resolution, record archiving and site closeout activities
Therapeutic Areas:
Anemia
CKD
Adjuvant Oncology Resources, Norfolk, VA, USA – Feb. 2010 – Jul. 2012
Senior Clinical Research Associate
Managed all site-related activities, from site selection to site close-out, consistent with clinical monitoring to ensure the successful enrollment, timely data capture and reporting in a manner consistent with Food and Drug Administration Regulations and ICH Good Clinical Practices
Provided intensive, targeted monitoring for study rescue at non-compliant or poorly performing sites
Provided day-to-day assistance to the client in-house clinical team by managing vendors and Clinical Research Organizations, reviewed protocols, developed tools for site staff, wrote SOPs, provided on-site training for Clinical Research Associates and conducted Good Clinical Practices training to investigative site and client staff.
Therapeutic Area
Ophthalmology
CROfessionals, VA Oct 2009 to Feb 2010
Senior CRA (Contractor)
Participated in protocol and CRF development
Conducted basic study monitoring activities, SDV, IP accountability and Site/Regulatory Docment review.
Ensured regulatory and protocol compliance with sites of investigator/investigative site
Coordinates Sponsor's communications with sites to ensure investigators' responsibilities
Detected and reported protocol deviations to Study team
Managed site payments according to Investigator Agreement/Site Contract
Assists with the preparation of documents for regulatory submission, such as typing parts of
reports and tables
Assisted Project Manager in the preparation of safety summaries for inclusion into protocols
and Investigator Brochure updates
Assists in the compilation of the Clinical Report
Periodically acts as a mentor to ensure consistency across sites for the project
Therapeutic Area
Thrombocytopenia (Phase Ill)
PPD Inc., Norfolk, VA, USA – Oct. 2007 – Aug 2009
Senior Clinical Research Associate
Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
Conducted site visits to determine protocol and regulatory compliance and prepares required documentation
Developed collaborative relationships with investigative sites and client company personnel
Duties performed include but not limited to: study start-up, pre-study visits study initiation visits, interim monitoring and close out monitoring
Applied Spine, Rocky Hill, CT, USA – Oct. 2006 – Oct. 2007
Clinical Specialist/Clinical Research Associate
Managed sites involved in FDA IDE clinical trial, including but not limited to:
Completed protocol instruction to sites
Completed study initiation visits
Interim monitoring
Surgical procedure monitoring
Surgical procedure Training
Performed and coordinated assigned aspects of the clinical monitoring for the IDE Trial
Worked with Physician's and Clinical coordinators to improve site enrollment
Point of contact between investigators and company
Met with and communicated with Investigators weekly
Taught surgical technique at Cadaver labs
Represented company at Industry meetings
PPD Inc., BlueBell, PA, USA – Apr. 2006 – Oct. 2007
Clinical Research Associate
Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
Conducted site visits to determine protocol and regulatory compliance and prepares required documentation
Developed collaborative relationships with investigative sites and client company personnel
Duties performed included: study start-up, pre-study set up and visits, study initiation visits, interim monitoring, close out monitoring, query resolution
lntegra LifeSciences, (Medical Device/Biotech), Hightstown, NJ, May 2001 – Feb. 2006
Clinical Project Manager - May 2004 – Feb. 2006
Clinical Research Associate - May 2001 – May 2004
As Project Manager:
Managed registrational and pos-markting studies
Managed Company’s Dissection Laboratory (Cadaver)
Managed product development cadaver labs
Managed Company sponsored Cadaver/animal training labs
Wrote and reviewed SOP's
Developed CRF's (mainly eCRFs)
Managed Sponsor TMF files
Reviewed and responded to adverse event reports
Managed and helped performed multiple pre-clinical studies
Planned and assisted with training meetings
As Clinical Research Associate:Monitored clinical studies, including pre-study set up and visits, study start-up, study initiation visits, interim monitoring, close out monitoring, query resolution
Managed and monitored over 50 sponsored research projects, both pre and post market studies
Monitored studies at major teaching hospitals/academic medical centers across the U.S.
Member of protocol development/review teamReviewed and responded to adverse event reports
Methodist Hospital, St Louis Park, MN, USA – Nov. 2001 – Jun. 2002
Surgical Assistant Neurosurgery - Nov. 2001 – Jun. 2002
Assisted Surgeons during surgery
Abbott Northwestern Hospital, Minneapolis, MN, USA - 1997 – 2001
Neurosurgery/Spine Surgery -1997 – 2001
Assisted Surgeon during surgery
Sentara Norfolk General, Norfolk, VA, USA - 1985 – 1997
Surgical Assistant, General, Bariatric, Gynecology, Cardiothoracic, Spine/Neurosurgery Clinical Instructor 1985 – 1997
Assisted Surgeon during surgery
Eastern Virginia Medical School (EVMS), Norfolk, VA, 1984 – 1985
Technical Director/Instructor - 1984 – 1985
Previous instructor in microsurgery to surgical assistant students and plastic surgery residents
Previous supervisor in microsurgical research
United States Navy, US Navy - Aug. 1979 – Aug. 1983
HM-1 (Hospital Corpsman First Class) – Aug. 1979 – Aug. 1983
Education:
Basic Science, Hennepin County Community College, Minneapolis, MN, USA
B.S. - Medical Marketing. Shefield University, Shefield, U.K. (Distance Learning)
Professional Training
PPD Foundation Training
Comprehenensive CRA training via ACRP and SOCRA while at PPD
Surgical Technician School, Operating Room Technician "C" School and Hospital
Corpsman "A" School, United States Navy, NRMC San Diego, Californ
General Studies and Chemical Dependency Counseling
Emergency Medical Technician
Contact this candidate