Imaging Research Associate

BioClinica, Inc • Newark, CA 94560

Posted 2 weeks ago

Job Description

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.

* 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

This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.

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