clinical research associate resume example with 8+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Professional Summary
Accomplished Sr Central Monitoring Associate with over 20 years of experience performing and documenting regulatory document collection, site initiating monitoring, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of central monitoring and TMF platforms.
Special Knowledge
Trial methodologies
Data Collection
Collecting regulatory documents
Project development
Protocol adherence
Database locking
Report writing
Subject tracking tools
Patient recruitment
Coordinating site operations
Developing study tools
Employee training
Investigator meetings
Completing regulatory documents
Pre-study visits
Meeting reporting
Work History
05/2019 to 02/2023
Senior Central Monitoring AssociateCatalyst Pharma Group, Inc. – Coral Gables, FL,
Primary contact for project site personnel, in collaboration with on-site CRAs.
Performed site management including evaluated performance of remote site qualification, remote site initiation, remote site monitoring calls (SMCs), and remote close-out visits ensuring regulatory, ICH-GCP and protocol compliance, and completed required actions as requested by Clinical Leads and/or Lead CMAs.
Ensured all assigned sites and project-specific site team members were trained and compliant with applicable requirements.
Responsible for ensuring correct IP receipt, handling and storage; knowledge of protocol, study procedures and adherence to study Clinical Monitoring Plans; supporting subject/patient recruitment and retention strategies; collection, ongoing review, and maintenance of study documents to ensure accuracy, timeliness and completeness of Trial Master file (TMF); remotely reviews electronic data and assist sites in resolving queries and/or other identified data issues.
Documented monitoring activities via confirmation letters, follow-up letters, and reports within established timelines.
Performed site-level Key Risk Indicator (KRI) Review utilizing appropriate tools to identify, respond to and manage issues .
Monitored site performance metrics and with guidance implements action plans for sites not meeting expectations.
Performed all tasks routinely and independently while providing support for team members as needed.
Demonstrated effective conflict resolution and resolves complex issues; routinely anticipates/identifies potential issues and implements corrective issues.
Mentored junior CMAs.
Certified Central Monitor accredited by the International Academy of Clinical Research (IAoCR) (via classes and workbook).
08/2018 to 05/2019
Senior Clinical Research Associate IIMayo Clinic – Waterville, MN,
Performed site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
Evaluated overall performance of site and site staff and provided recommendations regarding site-specific actions; immediately communicated/escalated serious issues to the project team and developed action plans. Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verified the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrated diligence in protecting the confidentiality of each subject/patient. Assessed factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Performed investigational product (IP) inventory, reconciliation and reviews storage and security. Verified the IP had been dispensed and administered to subjects/patients according to the protocol. Verified issues or risks associated with blinded or randomized information related to IP. Applied knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciled contents of the ISF with the Trial Master File (TMF). Ensured the investigator/physician site was aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supported subject/patient recruitment, retention and awareness strategies. Entered data into tracking systems as required tracking all observations, ongoing status and action items to resolution.
Acted as a primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensured all assigned sites and project-specific site team members were trained and compliant with applicable requirements.
Prepared for and presented at Investigator Meetings and/or sponsor face to face meetings. Participated in and led global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attended clinical training sessions according to the project specific requirements.
Provided guidance at the site and project level towards audit readiness standards and supported preparation for audit and required follow-up actions.
Provided direct supervision, training and/or mentorship to more junior level CRAs. Performed training and sign off visits for junior CRA staff, as assigned.
Was assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This included participation in business development proposals and/or defense meetings.
06/2017 to 07/2018
Research Study CoordinatorLouisiana State University – Baton Rouge, LA,
Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits were performed on-site and remotely
Reviewed completion of proper informed consent procedures
Ensured accurate data reporting via review of site source documents and medical records
Interpreted data to identify protocol deviations and risks to subject safety/data integrity
Generated queries and managed resolutions with site personnel
Performed investigational product accountability as per the protocol and Study Monitoring Plan
Evaluated execution of study protocol at the site level. Used judgment and experience to evaluate overall performance of site and site staff and provided recommendations regarding site-specific actions; immediately communicated/escalated serious issues to the project team.
Obtained, reviewed, and processed essential regulatory and administrative documents. Conducted audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan
Understood project scope, budgets, and timelines; managed site-level activities / communication to ensure project objectives, deliverables and timelines were met. Was able to quickly adapt to changing variables to achieve goals / targets.
Acted as primary liaison with study site personnel
Participated in the identification and selection of investigators and clinical sites
Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required
Provided mentoring / training to less experienced staff. Performed Monitoring Evaluation or Quality Assessment Visits
Interacted with representatives of client affiliates as per project requirements
Education
Expected in 12/2000 to to
Associate of Science: Biology University of North Carolina At Wilmington - Wilmington, NC GPA:
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