Michael Roberson Email & Phone Number

Raleigh, Nc, Us

Raleigh, Nc, Us

Bethesda, Maryland, United States

Promoted to Trial Master File Specialist III

Bethesda, Maryland, United States

Bethesda, Maryland, United States

United States

The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to: Assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation Coordinate or assist in distribution of trial-related materials to study sites May assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file held by TRI or Sponsor/Client Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs Track essential regulatory documents in a centralized web-based system and/or other database Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills

United States

Currently I am enrolled in the Amazon Cloud Institute where I am learning how to become a Cloud Application Developer.

Morrisville, North Carolina, United States

Be the point of contact for investigational sites, vendors, and multi-functional project teamsBe responsible for document managementUpdate and maintain (automated) tracking systems and schedulesCoordinate various activities within clinical research projectsOrganize meetings, prepare agendas and minutes

Morrisville, North Carolina

Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. • Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. • Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information. • Provide administrative support to Project Leads and functional leads. • Ensure all study documents are archived based on the appropriate guidelines and policy. • Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues

Raleigh-Durham, North Carolina Area

Responds accurately and professionally to technical and medical information inquiries received via phone, email, Internet or mail in reference to pharmaceutical or device products. • Processes fulfillments and provides clinical trial information or after-hours on call support. • Analyzes caller’s questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines. • Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed. • Maintains knowledge of project and corporate policies and procedures including client products, SOP's, protocols, GCP's, and all applicable regulatory requirements. • Works with internal and external client contacts to resolve inquiries. As needed, researches medical literature and drafts responses for such inquiries. • Provides administrative support as needed.

Bachelor'S Degree, Psychology/ Business Studies

Associate Of Arts - Aa, General Studies