Imaging Research Associate II

The Imaging Research Associate II coordinates all Medical Imaging services and operational activities, from study start to study close, to ensure the timely delivery of high quality images service deliverables for assigned studies.

Primary Responsibilities

• Responsible for executing any/all of the functions that an Imaging Research Associate I, performs
• Communicate with Project Manager and/or Sponsor regarding operational deliverables on assigned studies
• Planning, coordinating and leading the site start-up activities
• Communicate with clinical sites regarding radiograph and/or DXA image quality, data discrepancies and changes in image collection procedures
• Participate in creation and distribution of clinical site training materials (i.e study specific manuals, videos and translations) and sponsor/clinical site reports
• Provide technical site support (i.e. field clinical site questions pertaining to study related data, confirm site eligibility)
• Create study specific data tracking tools
• Monitor processing of technical and logistical edit checks and outliers and assist other study team members as needed to maintain study deliverables
• Report metrics of operational deliverables on assigned studies to Manager, Site Services
• Participate in internal and external audits
• Perform configuration qualification testing
• Monitor and report contract (i.e. fee schedule and statement of work) changes, affecting site management and data processing, to the Clario Clinical Project Manager
• Understand functions of software used to produce and collect DXA image analysis results
• Train internal staff on study specific procedures

Maintains client (internal and external) satisfaction by:

• Processing all study related data in a timely manner
• Generating site communication in a timely manner
• Establishing a rapport with study personnel, clients and others in a position to help meet the client's needs
• Responding to inquiries in a professional, courteous and timely manner
• 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
• Monitor and prepare IQC Correction Factors for corrected interim/final data transfers
• Understand functions of software used to produce and collect IQC data
• Demonstrate and train on IQC Data processing routines for internal and external customers
• Coordinate with clinical study teams, Clario Clinical Project Managers and Clinical Data Managers for transfers that include IQC corrections
• Generate IQC correction factors/reports for interim and final study transfers

Assists Project Managers with project administration by

• Planning, coordinating and leading 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

Supports Site Services initiatives by

• Supporting the Manager, Site Services in operational leadership activities
• Mentors and coach's new hires and supports onboarding activities
• Leads process improvement efforts and pilot's new processes
• Provides training on operational processes and updates flowcharts and SOPs

Maintains Quality Service and Departmental Standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
• Assist with operational process improvement
• Train for ongoing and new-hire IQC team members on IQC data processing

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

Qualifications:

Education:

• College degree in science preferred or 2 years equivalent experience in Clinical or Imaging Operations, or field of densitometry

Experience:

• Sound knowledge of clinical research and "good clinical practice" requirements. Prior experience in clinical trial management or monitoring.
• At least 6 months in an Imaging Research Associate (or equivalent) role.
• Familiarity with PC-based computers and standard software packages including e-mail, word processors, Excel spreadsheets and database
• 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:

• Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines.
• Knowledge of basic clinical research preferred. Knowledge of anatomy a plus
• 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
• Strong documentation and organizational skills
• Ability to project and maintain a professional and positive attitude
• Leadership skills. Self-motivated with ability to work in teams with minimal supervision, with aggressive deadlines
• Goal oriented

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.