Organized Virtual Assistant dedicated to improving accuracy and efficiency by maintaining and developing administrative and procedural processes. Focused and communicative individual possessing superb data entry, time management and customer service skills. Offering 5 years of experience providing quality administrative support to clients.
Enthusiastic Remote Site Manager eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of the importance of establishing and maintaining a trust worthy rapport while providing site support ,encouragement and confidence. Motivated to learn, grow and excel in the pharmaceutical industry.
• Perform site start-up/regulatory, monthly routine contact calls and close out visits in accordance with scope of work, using good clinical practices applicable to FDA regulations, SOPs and work instructions.
• Administer protocol and related study training to assigned sites for EDC training, SIV slides and establish regular lines of communication with site to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to SML (Site Manager Lead), CPM (Clinical Project Manager) and/or LM (Line Manager)
• Manage the progress of assigned studies by documenting IRB regulatory submissions and approvals, recruitment, enrollment, CRFs (Case Report Forms) completion and data query generation and resolutions. Track all essential documents in CTMS, i.e. 1572s, FDFs (Financial Disclosure Forms), as we'll as Laboratory documents i.e., CLIAs, CAPS, Normal Lab Ranges, followed by regular review and reconciliation of all documents posted to eTMF.
• Create and maintain appropriate documentation for all site contacts by generating confirmation and follow-up letters, TCRs (Telephone Contact Reports).
• Schedule and conduct Remote Monitoring Visits, create site findings and propose action plans to sites by writing SVR (Site Visit Reports) and submitting to sites.
• Complete annual file reviews by resolving and collecting missing documents and action items that are unanswered, this include constant contact with the site to retrieve and resolve accordingly.
• Assist sites with negotiation of CTA Amendments to ensure full execution and implementation hence, proper site payments.
• Right hand to Project Manager for urgent requests, site summaries, query resolutions and resolving site findings which includes frequent follow-up and documentation as such. Provide Study Team with updates and statuses for all sites regarding outstanding issue by showing due diligence in attempt to obtain solutions.
• Right hand to CRA while onsite preforming OMV (Onsite Monitoring Visits), i.e. source document verification, ISF (Investigator Site Files) Binder review on a routine basis.
• Provide support and encouragement to sites at all times ultimately improving patient outcome.
• Coordinate administrative functions throughout the clinical department including file reviews to ensure FDA Compliance and audit readiness
• Review and reconcile project reports, perform mass-mailings regarding protocol amendments and Investigator Brochures and distribute to sites
• Performs PPD Investigator file reviews and logs findings in CASCADE
• Maintain up-to-date data points within CASCADE and CTMS according to the established naming conventions pertaining to study specifics
• Create and resolve outstanding regulatory findings and site issues
• Follow-up on site deviations and communicate status to PM
• Coordinates non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager
• Primary contact for sites to retrieve essential and non-essential regulatory documents
• Work closely with CTMs )Clinical Trial Managers) and RSMs (Remote Site Managers) in query resolutions and site findings
• Track and maintain study related materials including Case Report Forms
• Attend Kick-Off meetings as the primary Notetaker
• Attend study team meetings and sponsor related conference calls
• Hand Over Lead: Responsible for review of documents submitted by SIA: Oncology Therapeutic Area and related studies
• Performed a high volume of data entry which included
• Processed Adult Care applications
• Completed and Verified Documentation
• Identified and Resolved Problems
• Updated Records, Reports, Files
• Served as the public contact with walk-ins and potential Adult Caregivers.
• Tracked complaints and followed up on investigation reports
• Provided phone coverage and other supportive licensing and regulatory functions
• Managed quality assurance methods, including evaluation of customer applications and surverys
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