This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
The Imaging Research Associate I coordinates all site and operational activities, from study start to study close, to ensure the timely delivery of high-quality service deliverables for assigned studies.
-
Assist in preparation and reproduction of study materials during study start-up phase of clinical trials
-
Follow up with outstanding documentations from clinical sites to complete site qualification
-
Schedule logistical and technical trainings with site personnel
-
Create test run requests for sites submitting digital data
-
Review, process, track and monitor all study related data received from sites
-
Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management
-
Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors
-
Investigate and complete logistical edit checks
-
Report issues found with study systems (i.e. study database, reading analysis system)
-
Perform day to day IQC activities including coordinating, requesting, tracking and processing of IQC data including:
-
Baseline, on-going, and end/interim analysis
-
IQC Data Review
-
Coordination of cross calibration phantom rotation
-
Phantom data analysis and data entry
-
Ensuring accuracy of tracking information in IQC Tracking and study tracking databases as pertaining to IQC and/or DXA scanner information
-
Coordinating machine change instances for appropriate documentation and equivalence data collection
-
Machine Equivalence analysis and processing
-
Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements
-
Manage Baseline, Interim and End of Study IQC data submissions, track and report progress to study teams and ensure timelines are met
-
Communicate with BioClinical clinical study team and/or sponsor regarding deliverables
-
Understand functions of software used to produce and collect IQC data
-
BMD Scan Review Form preparation
-
Study database maintenance (e.g., change of contact information)
-
Assists Project Managers with project administration by:
-
Planning and coordinating the site start-up activities
-
Reading and understanding project protocol documents
-
Entering, maintaining, and tracking of data in internal software
-
Participating in project meetings, conference calls, and training calls
-
Assists Project Managers in maintaining, reviewing and communicating project progress by:
-
Reviewing and analyzing project tracking weekly
-
Generating, tracking and resolving data queries
-
Identifying site and data trends, and recommending actions to Project Manager
-
Communicating and following up on project tracking discrepancies
-
Assisting in monitoring data flow
-
Generating, reviewing and distributing weekly/monthly project tracking reports
-
Ensures the development and adherence to project timelines as they relate to therapeutic processes by:
-
Following up on outstanding items including missing data, incomplete paperwork, etc.
-
Managing site communication, including distribution of subject data reports
-
Assisting in tracking and resolving of client issues
-
Scheduling and tracking completion of site training
-
Serving as additional point of contact to client, sites, sponsors, etc.
-
Keeping supervisor advised of current issues
-
Maintains client (internal and external) satisfaction by:
-
Responding to inquiries in a professional, courteous and timely manner
-
Maintains Quality Service and Departmental Standards by:
-
Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
-
Assisting in establishing and enforcing departmental standards
-
Participating in the modification of company SOPs related to the therapeutic team
-
Maintains Technical and Industry Knowledge by:
-
Attending and participating in applicable company-sponsored training
Qualifications
-
High School Graduate or Associate/bachelor's degree in bioscience, computer science, information technology or related field preferred
Requirements
-
Familiarity with PC-based computers and standard software packages including e-mail, word processors, Excel spreadsheets and databases
-
Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred
-
Knowledge of “good clinical practices” preferred
-
Familiarity with network navigation and file saving conventions, including moving/copying files and folders
Benefits
-
Competitive compensation
-
Private health insurance
-
Engaging employee programs
-
Flexible work schedules
-
Attractive PTO plan
-
Flex workspace