CV

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Alexander K. Baldridge
Nashville, TN
615-513-2854
xanderb10@gmail.com
EMPLOYMENT HISTORY
SCRI
Clinical ResearchAssociate II July 2015- Present
 Assist in the Investigator selection and qualification process
 Assist in the development of patient recruitment strategy
 Attendance at Investigator Meetings
 Perform and document pre-study site evaluations, site initiations, regulatory document
collection, interim monitoring and study close out visits in accordance with GCP, study-
specific requirements, clinical monitoring plans, company standard operating procedures,
applicable regulatory requirements and defined quality and performance standards
 Ensure site IRB approval is current and all IRB documentation is in order
 Maintain site monitoring schedule and serve as the principal point of contact for
investigational sites
 Document and report on clinical study progress (i.e. patient recruitment and discuss
potential opportunities and risks with respective Project Team members)
 Ensure patient safety is maintained and informed consent procedures are carried out
 Provide training and update investigative site team of any changes in study conduct and
documentation requirements
 Ensure continued acceptability of the investigator, clinical site team and facility
 Review clinical data, source documentation, CRF, and investigative site regulatory files
 Work closely with data management and site to resolve discrepancies
 Ensure investigational product accountability accuracy and oversee investigational
product inventory
 Liaise with vendors such as central laboratories as required to ensure protocol adherence
and ensure investigational sites have appropriate clinical supplies
 Meet with clinical study sponsor representatives as requested
 Submission of routine monitoring visit reports and follow-up letters as per required
timelines.
 Ensure resolution of issues with investigative sites
 Attend meetings as assigned and report on actions
 Participate in educational activities and programs
 Maintain strictest confidentiality
 Work closely and effectively with all other department personnel to ensure appropriate
communication and study conduct
 Assist other staff as requested and perform other related work as needed
 Function as a mentor for team members
 Maintain awareness of current developments in therapeutic area relative to assigned
projects

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 Throughout the conduct of the clinical trial assesses adherence to SCRI SOPS, GCP and
all applicable regulatory requirements
 Travel is required. May also involve travel to meetings or attendance at conferences.
Overnight stays may also be required. In addition, weekend and evening
ICON CLINICAL RESEARCH
CRA II October 2014 – July 2015
 Identification, selection, initiation, and close-out of appropriate investigational sites for
clinical studies.
 Monitor those sites in order to ensure that studies are carried out according to the study
protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.
 Involvement, when required, in other areas of study management and staff training.
 Contribute to the review of ICON systems and procedures, as appropriate.
 Coaching and mentoring of monitoring competence to inexperienced/less experienced
colleagues.
 Contribute to the culture of process improvement with a focus on streamlining our
processes adding value to our business and meeting client needs.
 Recognize, exemplify, and adhere to ICON’s values which centre around a commitment
to People, Clients and Performance.
 Independently and proactively coordinate the necessary activities required to set up and
monitor a study.
ICON CLINICAL RESEARCH
CRA I January 2013 – October 2015
 Identify, select, initiate and close-out appropriate investigational sites for clinical studies.
 To monitor those sites in order to ensure that studies are carried out according to the
study protocol and in accordance with SOPs/WPs, applicable regulations and principles
of ICH-GCP.
 Recognize, exemplify and adhere to values which center around a commitment to People,
Clients and performance.
 To contribute to a culture of process improvement with a focus on streamlining processes
adding value to business and meeting client needs.
 Maintain timelines. Ensure accuracy and completeness of data entered into various
systems.
 Familiarity with principles of investigator recruitment.
ICON CLINICAL RESEARCH
SSUA I March 2012 – January 2013
 Responsible for the independent preparation, review and approval of country related
submission packages in accordance with ICH, GCP and all applicable regulations, laws
and other guidelines and ethical standards – within specific timelines and quality
standards.

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 Responsible for independent preparation, review and approval of site level critical
documents for Investigational Product (IP) release in accordance with regulatory /
sponsor requirements – within specific timelines and quality standards.
 Work with sites to finalize Site Specific Informed Consent Forms in accordance with
ICON, site and sponsor specifications.
 Accountable for the collation and verification of the submission documentation in
assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs
and other bodies as appropriate in assigned countries.
 Review and negotiate Investigator contracts and budgets.
 Use sponsor approved fallback language and budget parameters appropriately.
 Maintain communication with Investigative sites, Sponsors and internal personnel
regarding status of contract and contract-related documents
ST. THOMAS RESEARCH INSTITUTE
Clinical ResearchCoordinator September 2010 – March 2012
 Increased weekly enrollment from 30% to 85% or higher every week for CDC EPIC
study.
 Handled multiple contacts and brought a team together while completing weekly,
monthly and quarterly study goals.
 Performed chart audits, all study related documentation, and patient consenting under
Good Clinical Practices.
 Operated under four studies: EPIC (lead coordinator), SPRINT, MTG Fresh Tissue, and
CDC Flu Study.
VANDERBILT INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH
Clinical Trial Assistant October 2009 – May 2010
 Helped develop study protocol for Statin Trial for Influenza Patients.
 Maintained and managed communication with all clinical sites.
 Reviewed and managed all documentation from clinical sites.
EDUCATION
University: Lipscomb University, January 2008 – August 2010, Molecular Biology, BS
University: University of Evansville, August 2005 – August 2007, Movement Science
PROFESSIONAL QUALIFICATIONS
Computer Skills: Microsoft Office, Various EDCs, Electronic TMF

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QUALIFICATIONS SUMMARY (CRAs):
Years as a CRA (total number): 3.5
Therapeutic Area(s): Rheumatology, Cardiology, Endocrinology, Renal, Oncology
Years of Oncology Experience (as a CRA): 2
Indications (within Oncology only): Non-Small Cell Lung Cancer, Heme/Leukemia, Solid
Tumor (refractory), Breast, molecular profile based trials
Phases (within Oncology only): Phase I, II