Research Assistant II (Internal Posting)

Responsibilities:

• Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
• Based on business needs, may provide assistance to the following functional areas:

• Research Operations
• Endpoint and Specialty Services
• Site Operations
• Data Management
• Quality Control
• Trial Master File

• Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
• Perform a variety of general administrative tasks such as filing, copying, and preparation of shipments for assigned projects.
• Upload essential documents into eTMF system.
• Perform quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
• Perform ALCOA+ checks of documents uploaded into eTMF system.
• Participate in project, program, functional area and general CPC meetings as required.
• Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
• Coordinate and track receipt of project supplies to study sites
• Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
• Assist in the development, administration, and tracking of project specific training.
• Manage email reconciliation and export at study close-out.
• Collect and review investigational site documentation and process as directed.
• Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation.
• Serve as one of the primary points of contact for investigational sites.
• Perform query management, report generation, and data reconciliation tasks.
• Assist with User Acceptance Testing (UAT)
• Manage user access requests (including user reconciliation).
• Perform general data review of study data in EDCs

Qualifications:

• GED or HS Diploma required. Nursing or bachelor’s degree preferred.
• Minimum of 1 years of experience working in a clinical research (or similar) setting. Higher degree may be considered in lieu of experience.
• Demonstrated ability to complete core tasks with minimal direction, while reliably escalating for guidance on less routine assignments.
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. 
• Good understanding of the drug development process.
• Proficiency in MS Office, particularly spreadsheet databases and word-processing.
• Excellent communication and organizational skills.
• Great attention to detail
• Ability to work with others in a manner that promotes group effort and achievement.
• Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks.
• Ability to manage conflicts and resolve problems effectively.
• Ability to discern priorities and obtain direction to accomplish day-to-day tasks.