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 Bioclinica 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
Generates, tracks and resolves 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:
Education:
High School Graduate or Associate/Bachelor's Degree in bioscience, computer science, information technology or related field preferred
Experience:
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
Additional skill set:
Ability to work in group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Ability to provide and maintain a professional and positive attitude
Leadership skills. Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines
Strong documentation and organizational skills
Goal oriented
Working conditions:
Travel: 0-5%
Lifting: 0-50lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
