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Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
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Professional Summary

Enthusiastic clinical research professional eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Motivated to learn, grow, and excel in the clinical research industry.

Skills
  • Meeting study timelines through effective team organizing
  • Creating study documents
  • Presenting powerpoints in front of stake holders
  • Monitoring , measuring , and mitigating risk factors
  • Managing 3rd Party Vendors
  • Mentoring Junior Team Members
  • Negotiating budgets with 3rd parties
  • On-site auditing of contracted sites
  • Remote auditing of contracted sites
  • Filing and organizing essential documents
  • Mitigating and resolving conflicts
  • Microsoft Suites
Education
Wesleyan University Middletown, CT, Expected in 05/2016 Bachelor of Arts : Molecular Biology & Biochemistry - GPA :
Work History
Elara Caring - Clinical Team Manager
Liberty, MO, 09/2021 - Current
  • Manages all clinical operational and quality aspects of allocated studies, in compliance with ICH Good Clinical Practice (GCP).
  • Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File. Participates in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • Collaborates with the clinical team and other departments to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
  • Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. Routinely conducts Accompanied Field Visits (AFVs) and is accountable for project financials.
  • Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
  • Coordinates start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions are addressed. Reviews and follows up on all questions raised by ethics committees.
  • Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Inc Research Inc - Senior Clinical Research Associate
Home, AZ, 02/2020 - 09/2021
  • Met Biosplice (sponsor) timelines and remained adaptable despite rapidly changing landscape due to COVID-19 pandemic.
  • Performed Risk Based Monitoring reviews for clinical studies in order to spot and recommend actions for values approaching Quality Tolerance Limits and Key Risk Indicators.
  • Lead lab vendor sub-team and ensured that lab supplies arrived at clinical sites prior to scheduled site activation, errors were resolved in timely manner, and consistently occurring errors were addressed via Corrective Action Plan and Root Cause Analysis documentation.
  • Presented updates and directives regarding lab vendor to sponsor team during project meetings.
  • Communicated updates and requests regarding sponsor needs to lab vendor.
  • Compiled investigator site staff and sponsor staff contact information on Microsoft Excel sheets and provided them to lab vendor.
  • Guided development of sponsor developed Central Monitoring System (CTMS) to better address department needs when compared to third party vendor CTMS.
  • Leveraged sponsor developed CTMS knowledge, expertise, and problem-solving techniques to resolve issues presented by other team members.
  • Developed Site Activation Process Flow chart for sponsor staff to use during investigator site activation process.
  • Created source document templates for investigator sites to use on sponsor studies.
  • Continued to perform duties outlined under Clinical Research Associate II role.
Clinical Research Management - Clinical Research Associate II
Dayton, OH, 10/2018 - 02/2020
  • Mentored junior CRAs through regularly scheduled training meetings and co-monitoring visits to help ensure team success.
  • Performed budget and contract negotiations with investigative sites to amicably reach agreements while maintaining sponsor proposed budgets.
  • Interfaced with CTMS vendor, sponsor Systems team, and sponsor Project Management team to test and implement CTMS.
  • Leveraged vendor CTMS knowledge, expertise, and problem-solving techniques to resolve issues presented by other team members.
  • Assisted in development of Site Specific Blinding Plans by reviewing drafts for adequacy and practicality during site startup process.
  • Created investigative site feasibility questionnaires to screen for capable investigators and investigative sites with adequate resources to properly conduct trials.
  • Assisted in investigator and site selection by recommending qualified investigators and sites for participation in sponsor's clinical trials.
  • Continued to perform duties outlined under Clinical Research Associate I role.
Covance - Clinical Research Associate I
Charleston, WV, 08/2016 - 10/2018
  • Collaborated with clinical study sites on behalf of sponsor to troubleshoot and provide solutions to study-related issues.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
  • Reviewed data queries and listings and worked with investigative sites to resolve data discrepancies.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Gathered and organized clinical trial documentation to meet filing standards for sponsor eTMF.

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Resume Overview

School Attended

  • Wesleyan University

Job Titles Held:

  • Clinical Team Manager
  • Senior Clinical Research Associate
  • Clinical Research Associate II
  • Clinical Research Associate I

Degrees

  • Bachelor of Arts

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