Imaging Research Associate I

Primary Responsibilities

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.

• Review, process, track and monitor all study related data received from sites
• Manage Baseline, Interim and End of Study IQC data submissions, track and report progress to study teams and ensure timelines are met
• Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements
• Follow up with outstanding documentations from clinical sites to complete site qualification
• Baseline, on-going, and end/interim analysis IQC Data Review
• Phantom data analysis and data entry
• Assist in preparation and reproduction of study materials during study start-up phase of clinical trials
• Schedule logistical and technical trainings with site personnel
• Study database maintenance (e.g., change of contact information)
• BMD Scan Review Form preparation
• Machine Equivalence analysis and processing
• Coordination of cross calibration phantom rotation
• Communicate with Clario clinical study team and/or sponsor regarding deliverables
• Understand functions of software used to produce and collect IQC data
• Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management
• Investigate and complete logistical edit checks
• Coordinating machine change instances for appropriate documentation and equivalence data collection
• Perform day to day IQC activities including coordinating, requesting, tracking and processing of IQC data including:
• Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors
• Report issues found with study systems (i.e. study database, reading analysis system)
• Create test run requests for sites submitting digital data
• Ensuring accuracy of tracking information in IQC Tracking and study tracking databases as pertaining to IQC and/or DXA scanner information

Assists Project Managers with project administration by

• Planning and coordinating the site start-up activities
• Participating in project meetings, conference calls, and training calls
• Entering, maintaining, and tracking of data in internal software
• Reading and understanding project protocol documents

Assists Project Managers in maintaining, reviewing and communicating project progress by

• Generating, reviewing and distributing weekly/monthly project tracking reports
• Serving as additional point of contact to client, sites, sponsors, etc.
• Communicating and following up on project tracking discrepancies
• Ensures the development and adherence to project timelines as they relate to therapeutic processes by
• Reviewing and analyzing project tracking weekly
• Keeping supervisor advised of current issues
• Assisting in monitoring data flow
• Assisting in tracking and resolving of client issues
• Following up on outstanding items including missing data, incomplete paperwork, etc.
• Generates, tracks and resolves data queries
• Scheduling and tracking completion of site training
• Identifying site and data trends, and recommending actions to Project Manager
• Managing site communication, including distribution of subject data reports

Maintains client (internal and external) satisfaction by

• Responding to inquiries in a professional, courteous and timely manner

Maintains Quality Service and Departmental Standards by

• Assisting in establishing and enforcing departmental standards
• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
• 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

Education

Qualifications:

• High School Graduate or Associate/Bachelor's Degree in bioscience, computer science, information technology or related field preferred

Experience

• Knowledge of “good clinical practices” preferred
• Familiarity with PC-based computers and standard software packages including e-mail, word processors, Excel spreadsheets and databases.
• Familiarity with network navigation and file saving conventions, including moving/copying files and folders
• Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred

Additional Skill Set

• Excellent attention to detail and orientation toward meticulous work
• Strong documentation and organizational skills
• Goal oriented
• Strong interpersonal and communication skills, both verbal and written
• Leadership skills. Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines
• Ability to provide and maintain a professional and positive attitude
• Ability to work in group setting and independently; ability to adjust to changing priorities

Working Conditions

Travel: 0-5%

Lifting: 0-50lbs

Other: Computer work for long periods of time

EEO Statement

Clario is an equal opportunity employer. Clario 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.

Communication, Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We’re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors

• We learn; embracing change, questioning how we work, finding a better way. And if it doesn't go to plan, we don't blame each other; instead, we own it and grow together
• We partner' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Critical Thinking, Deliver Exceptional

We step forward because responsibility powers us; we don’t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors

• We prioritize; focusing on what matters, never compromising on quality.
• We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., Delivery, Issue/Risk Management, Learning Agility, People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients—and each other. We’re united by our purpose—it’s why we go above and beyond to support each other, emphatically.

Behaviors

• We do the right thing; for our customers, patients, sites and each other. And We're passionate about it.
• We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed., Sponsor/Internal Feedback, Team Player/ Contributor