Clinical Research Associate
Resume:
Linnea M. Smith
Baltimore, MD *1207
*********@*****.***
IQVIA September 2021-May2025
Senior Clinical Research Associate II
●Performed site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
●Worked with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
●Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
●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 as appropriate.
●Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment. Supported start-up phase.
● Ensured copies/originals site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
●Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
●Collaborated and liaised with study team members for project execution support as appropriate.
●Peer mentor. CRA School Trainer, Subject Matter Expert.
Prism Vision Group- The Retina Care Center, LLC October2020-September2021
Clinical Research Coordinator
●Management of multiple protocols and projects through the development of work plans, study/project timelines and trackers in coordination with protocol teams to include the PI, study team, study Sponsors, and/or collaborative institutions
●Managed version control of protocol and supporting documents throughout protocol submission and approval process
●Collaborated with Investigators and/or clinical trial sponsors to develop scientific and regulatory documents for submission to the FDA, IRB, and IBC
●Oversee and implement site activation procedures to include planning the agenda, developing training materials, and training of site personnel
●After study approval and initiation, management of all subsequent protocol lifecycles actions (amendments, continuing reviews, safety reporting, deviation reporting, etc.) until study closure.
PPD January 2018 – January 2019
Clinical Research Associate II
●Attended sponsor calls and internal team calls to stay informed of current study issues
●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 prepared required documentation
●Developed collaborative relationships with investigative sites, client company personnel and study vendors
PRA Health Sciences September 2015 – November 2017
Clinical Research Associate I
●Implemented and monitored clinical trials to ensure sponsor and investigator obligations were being met and were compliant with applicable local regulatory requirements and ICH-GCP guidelines
●Assessed the qualifications of potential investigative sites, initiated clinical trials at investigative sites instructed site personnel on the proper conduct of clinical trials, and closed clinical trials at investigative sites
●Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely
●Provided regular site status information to team members, trial management, and updated trial management tools
●Completed monitoring activity documents as required by PRA SOPs or other contractual obligations
●Worked closely with other clinical team members to facilitated timely resolution of trial and/or clinical issues
●Performed source documents verification and query resolution
●Assessed IP accountability, dispensation, and compliance at the investigative sites.
●Served as observation visit leader
●Facilitated audits and audit resolution
Sidney Kimmel Comprehensive Cancer Center February 2013- September 2015
Genitourinary Oncology at Johns Hopkins University
Research Program Coordinator
●Maintains good working knowledge of all assigned protocols and reporting requirements
●Maintains regulatory binders for each assigned protocol
●Maintains a protocol database or spreadsheet for tracking patient activity and data
●Prepares for and participating in monitoring and audits of studies.
●Preparation of materials for submission of the Johns Hopkins Institutional Review Board
Johns Hopkins University January 2012-January 2013
Research Program Assistant II/Coordinator
●Recruitment of children with asthma living in inner-city Baltimore
●Administration of research study protocols for both childhood and adult asthma studies, including direct participant interaction
●Performance of allergy skin testing and spirometry in research setting
●Development of forms and questionnaires for use in clinical research settings
●Maintenance of participant study materials
●Maintenance and updating several research databases
●Performance of quality assurance/quality control procedures
●Preparation of materials for submission of the Johns Hopkins Institutional Review Board
●Preparation of materials for submission of the Johns Hopkins General Clinical Research Center
Johns Hopkins University November 2009 - January 2012
Research Program Assistant/Coordinator
●Recruitment of children with asthma living in inner-city Baltimore
●Administration of research study protocols for both childhood and adult asthma studies, including direct participant interaction
●Performance of allergy skin testing and spirometry in research setting
●Development of forms and questionnaires for use in clinical research settings
●Maintenance of participant study materials
●Maintenance and updating several research databases
Johns Hopkins Outpatient Center Surgical Programs Summer 2009
Research Assistant
●Participated in design protocol, investigational protocol, epidemiology
●Responsible for client information database, handing out surveys to patients.
Baltimore Behavioral Health
Student Intern Summer 2009
●Assisted therapist with caseload of 25-30 adult mentally ill patients
●Facilitated mental health groups, conducted one on one therapy sessions
●Completed psychosocial assessments, provided crisis intervention
●Provided treatment plans for patients, documented in behavioral terms
Coppin State University March 2009 – Present
Experimental Psychology Research Lab
Research assistant to Dr. Katherine Cameron
· Responsible for preparation of survey questions & experimental forms
· Carried out research on cell phone use and dependency
· Collected and analyzed data from surveys on technology use in the classroom
· Co-presenter with Dr. Cameron at the 2009 Conference on Information Technology in Teaching and Learning at Coppin State University, May 21 2009 & October 2009
· Co-presenter with Dr. Cameron at the 2010 Eastern Psychological Association Conference in Brooklyn, New York, March 2010
Coppin State University Upward Bound Program 2005-2006
Office Assistant, work-study position, 12 hours/week
· Answered telephones, scheduled calendar, organized college tours
· Responsible for student files in Excel
Coppin State University Upward Bound Program Summer 2006
Teacher Assistant, paid position
· Graded student papers
· Assisted with teacher lesson plans & PowerPoint presentations
· Mentored students with research projects
Hunt Valley Animal Hospital 2004
Veterinarian Receptionist
· Scheduled Appointments; cashier, salesperson
EDUCATION
Coppin State University July 2009
Baltimore, Maryland
Bachelor of Science Psychology
PUBLICATIONS
Sonali Bose, Linnea Smith-Waters, Selvi Jeyaseelan, Harold Watson, Timothy Roach, Gregory Diette, Emmanuelle Clerisme-Beaty, Meredith McCormack. Developing a pilot study to study the determinants of vitamin D status in adult asthmatics in Barbados. Partnerships for Environmental Public Health (PEPH) annual meeting, Washington DC March 2012. Poster presented
CERTIFICATIONS
SoCRA- Certified Clinical Research Professional October 2012-Present
Continuing Education/Trainings
·Fundamentals for the Research Coordinator April 2011
· 2nd Annual ICTR Symposium: How to Succeed in the Face of Obstacles May2011
·NIOSH- Approved Spirometry April 2011
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