Investigator Research Assistant - St. Vincent Medical Center

About the role

Responsible for assisting in all aspects of Investigator Initiated Studies coordinated through the central coordinating center.

Responsibilities

• Act as a safety medical monitor when needed by reviewing and documenting the completion of the reviews of all clinical events and all serious clinical events recorded by the sites and provide a monthly report to the Central Coordinating Center (CCC) research team
• Assist in facilitating communication with central statistical center, Data Safety Management Team, the study sites that are reporting to the CCC, third party vendor providing the electronic data to the CCC and to all sites, any needed third party subcontract to maintain services needed across all sites and with the third party vendor, core imaging center and assuring timely completion of the tasks
• Reconcile and assist the manager in obtaining and completing the subcontracts from all the national research sites
• Assist in site initiation visits with slides to illustrate the study and requirements, Remote and occasional on site monitoring that requires travel to the sites
• Assist in drafting and proof editing study abstract, meeting presentations, submission of abstract to meeting website, help and drafting of the paper/manuscript preparation, double checking and performing statistical analysis as needed, submission of full paper to the journals
• Responsible for assisting with the clinical administrative operations activities involving clinical contract and budget support including but not limited to filing, scanning, mailing, populating spreadsheets and other administrative tasks as assigned.
• Filing the documentation obtained from all sites and maintaining it in accordance with regulatory and compliance rules as per FDA, and study regulations.
• Perform Quality Control (QC) on the scanned contracts to ensure: All pages of the documents are included; all required signatures are verified and present; all budget pages are legible; and all documents have been saved in the Shared Folder for CCC team.
• Assist with maintaining administration with the help of CCC team invoices from other sites. Work with financial analyst and manager to ensure the QC of the budgets and accounts.

Requirements

• Education: Bachelor's Degree in healthcare, research, or related field (required)
• Work Experience: 1 year experience in clinical research, writing, draft clinical paper, abstract submission to scientific meetings, submission of full clinical research paper to journal, base stat knowledge and analysis (required)
• Licensing/Certification: None
• Training: None
• Language: None

Skills

• Document management
• Microsoft Office
• Demonstrated knowledge of technology and its application to improving processes
• Demonstrated Management Skills Or Experience