Senior Clinical Research Associate Resume Example
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SENIOR CLINICAL RESEARCH ASSOCIATE
Professional Summary
Over 6 years of experience providing support to the Clinical Operations Manager(s)/Study Lead(s) to manage and track key study deliverables. Supports study teams to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines. Experience in phases I, II and III clinical trials. Excellent knowledge of ICH and GCP guidelines.
Skills
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Therapeutic Experience
- Oncology: Solid Tumor, Acute Myeloid Leukemia, Lymphoma, Breast Cancer, Uterine Cancer, Lung Cancer and CAR-T
- Neurology: Schizophrenia, Parkinson Disease, Autism,Post Traumatic Stress Disorder
- Infectious Disease: Flu
- Dermatology: Acne
- Medical Device: Cardiac Pacemakers
- Respiratory: Asthma
Work History
Aug 2020 - CurrentSenior Clinical Research AssociateNova Biomedical - Waltham , MA
- Provides high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
- Develops study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required.
- Manages the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements.
- Oversees clinical trial supplies related to collection, processing, shipment, and storage as, well as maintenance of associated tracking information.
- Monitors and tracks clinical trial progress.
- Develops new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies.
- Performs study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using CRO databases.
Jul 2017 - Aug 2020Clinical Research Associate IIDanaher - Nashville , TN
- Coordinated the oversight of sample collection.
- Coordinated the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
- Served as a liaison and resource for investigational sites.
- Traveled as required to carry out responsibilities.
- Participated in the development, review and implementation of departmental SOPs and processes.
- Participated in the development and preparation of study documents such as Protocol, Case Report Forms, Informed Consent, and Subject Questionnaire.
- Assisted in IRB submissions and communications throughout the study duration.
- Performed study initiation, site training, interim monitoring and study close-out, and completed timely and accurate site visit reports.
- Managed study sites to ensure enrollment goals are met in accordance with study protocol and timelines.
- Conducted pre-study site visits for assessment of investigator and site suitability.
- Ensured studies are conducted in accordance with Parexel SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
Jul 2015 - Jul 2017Clinical Research Associate ICovance - Cleveland , OH
- Assisted in overseeing PPD Therapeutics' clinical trials from initiation, planning, execution, maintenance and close-out.
- Coordinated investigational site startup activities, including the creation, preparation, and shipment of documentation.
- Coordinated contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Reviewed invoices from vendors/consultants as per contract.
- Coordinated and maintained relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.
- Reviewed and approved Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
- Participated in Site Initiation Visits.
- Conducted co-monitoring visits to oversee CRO personnel and study conduct at the site.
- Supported in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process.
- Assisted in the planning of Investigator Meetings and/or Site and CRA trainings.
- Assisted with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
- Reviewed clinical databases on a real time basis to identify/resolve data entry issues, tracks the
Jan 2012 - Jul 2015Clinical Research Coordinator (Oncology)UCLA - City , STATE
- Performed all aspects of the set up process to include the development and approval of study specific documents, study schedules and clinical procedure planning.
- Coordinated the running of critical events by resolving/escalating issues identified by both staff and study participants.
- Monitored and maintained participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as appropriate.
- Provided updates regarding study participants wellbeing to the investigators and Project Manager including adverse event updates.
- Learned and developed Clinical skills to perform study tasks and performed procedures as necessary.
- Created/managed study specific shipping calendar ensuring biological samples are shipped as directed by the client in a timely manner.
- Ensured all protocol deviations and or unscheduled events are properly documented and communicated.
Education
Bachelor of Science: Political ScienceUniversity of California - Los Angeles | City, State
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Resume Overview
School Attended
- University of California - Los Angeles
Job Titles Held:
- Senior Clinical Research Associate
- Clinical Research Associate II
- Clinical Research Associate I
- Clinical Research Coordinator (Oncology)
Degrees
- Bachelor of Science : Political Science
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