Enthusiastic Senior Clinical Research Associate eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of good clinical practice.
Skills
6+ years of site management experience.
Experience working with multi-functional project teams.
Computer literacy, including spreadsheet, database and word processing applications.
Knowledge of ICH and local regulatory authority regulations regarding drug.
Experience in monitoring all trial components (PSSV to COV).
Ability to travel as needed (greater than 70%).
Excellent attention to detail.
Excellent communication skills.
Experience working in phases I-III clinical trials.
Work History
03/2021 to Current
Senior Clinical Research AssociateNova Biomedical – Atlanta, GA,
Works independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
Assists with submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
Participates in preparing and reviewing study documentation and feasibility studies for new proposals as required.
Manages sponsor generated queries efficiently and responsible for study cost effectiveness.
Assists in training and mentoring less experienced CRA's.
Provides support to Project Team and Clinical Operations Team.
Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.
Serves as primary contact for assigned research sites.
Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
Verifies the rights and well-being of trial subjects are protected.
Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
May support translations of essential documents.
May support submission of trials to IRB/IEC and regulatory authorities.
Verifies that written informed consent was obtained before each subject’s participation in the trial.
Verifies that the investigator is enrolling only eligible subjects.
Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
Verifies and supports the recording and reporting of adverse .
01/2019 to 03/2021
Clinical Research Associate IIDanaher – Grand Island, NE,
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
11/2016 to 01/2019
Clinical Research Associate ICovance – Charleston, WV,
Conducted patient data monitoring for accuracy and protocol compliance.
Conducted site qualification, initiation and site closeout visits and complete all appropriate documentation related to the visits.
Provided support in site recruitment Support in the compiling and analysis of patient data.
Obtained/reviewed/processed regulatory and administrative documents from investigative sites.
Liaised with sites to ensure sufficient study drug is available for clinical activities.
Requested sites to return unused study drug and upon arrival review for shipment integrity.
Reviewed documentation of blood samples/specimens and tumor slides submitted by sites.
Maintained inventory of clinical supplies and ship to sites as needed Other duties as assigned.
01/2014 to 11/2016
Clinical Research Data CoordinatorNorthwest Hospital – South, WA,
Performed all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) were achieved.
Performed reconciliation of the clinical database against safety data, laboratory data and other third-party data.
Reviewed clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raised queries to resolve erroneous, missing, incomplete or implausible data.
Generated, resolved, and tracked queries to address problematic data identified during data review activities and apply proper modification/correction to the database.
Ran ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trials.
Interacted with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as necessary.
Created and reviewed data listings.
Assisted with creation/review of edit checks.
Created dummy data to test edit checks and to test database screen.
Assisted in creation of Study Test Plan and Study Test Report.
Performed database decommissioning and create supportive documentation.
Education
Expected in
Bachelor of Science: Nursing Carleen Health Institute - Florida, GPA:
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