临床研究助理 Imaging Research Associate 20天年假

Primary Responsibilities

The Imaging Research Associate I, coordinates all site an********act******** from study start to study close, to ensure the timelydelivery of high quality service deliverables for assigne********.

Assist in preparation an******** of study materials during studystart-up phase of clinical trials
Follow up with outstanding documentations from clinical sites tocomplete site qualification
Schedule logistical an******** trainings with site personnel
Create test run requests for sites submitting digital data
Rev******** process, track an******** all study relate********receive******** sites
Assist in the monitoring an******** of data discrepancies resulting fromdiscrepancy listings generate******** clinical data management
Manage site commun******** generate site an******** reports an********,an******** reports prior to distribution to clinical sites an********
Investigate an******** logistical edit checks
Report issues foun******** study systems (i.e. study ******** readinganalysis system)
Perform day to day IQC activities including coor******** re********tracking an******** of IQC data including:
Basel******** on-go******** an********/interim analysis IQC Data Review
Coordination of cross calibration phantom rotation
Phantom data analysis an******** entry
Ensuring accuracy of tracking information in IQC Tracking an********tracking databases as pertaining to IQC and/or DXA scanner information
Coordinating machine change instances for appropriate documentationan******** data collection
Machine Equivalence analysis an********
Ensure IQC data is collecte******** maintaine******** to applicable SOPsand/or study protocol requirements
Manage Basel******** Interim an******** of Study IQC data subm********track an******** progress to study teams an******** timelines are met
Communicate with Bioclinica clinical study team and/or sponsor regardingdeliverables
Understan******** of software use******** produce an******** IQC data
BMD Scan Review Form preparation
Study database maintenance (e.g., change of contact information)


Assists Project Managers with project administration by

Planning an******** the site start-up activities
Reading an******** project protocol documents
Enter******** ma******** an******** of data in internal software
Participating in project meet******** conference calls, an******** calls


Assists Project Managers in ma******** reviewing an******** projectprogress by

Reviewing an******** project tracking weekly
Generates, tracks an******** data queries
Identifying site an******** tren******** an******** actions to ProjectManager
Communicating an******** up on project tracking discrepancies
Assisting in monitoring data flow
Generat******** reviewing an******** weekly/monthly project trackingreports
Ensures the development an******** to project timelines as they relateto therapeutic processes by
Following up on outstanding items including missing ******** incompletepaperwork, etc.
Managing site commun******** including distribution of subject datareports
Assisting in tracking an******** of client issues
Scheduling an******** completion of site training
Serving as additional point of contact to cl******** s******** sponsors,etc.
Keeping supervisor advise******** current issues


Maintains client (internal an********) satisfaction by

Responding to inquiries in a profess******** courteous an******** manner


Maintains Quality Service an******** Standards by

Rea******** understanding an******** to organizational Standar********Procedures (SOPs)
Assisting in establishing an******** departmental standards
Participating in the modification of company SOPs relate******** thetherapeutic team


Maintains Technical an******** Knowledge by

Attending an******** in applicable company-sponsore********
Bachelors, Ch******** Engl******** Qualification********

Education:

High School Graduate or Associate/Bachelor's Degree



Experience:

Familiarity with PC-base******** an******** software packages includinge-ma******** wor********, Excel spreadsheets an********.

Knowledge of the drug developmen******** trials proce******** clinicalresearch and/or experience working in a pharmaceutical environmentpreferred

Knowledge of “goo******** practices” preferred

Familiarity with network navigation an******** saving convent********including moving/copying files an********



Additional skill se********

Ability to work in group setting an********; ability to adjust tochanging priorities

Excellent attention to detail an******** towar******** work

Strong interpersonal an******** sk******** both verbal an********

Ability to provide an******** a professional an******** attitude

Leadership skills. Self-motivate******** ability to work in teams withminimal superv******** with aggressive deadlines

Strong documentation an******** skills

Goal oriented



Working condition********

Travel: 0-5%

Lifting: 0-50lbs

Other: Computer work for long periods of time



This position description shoul******** be deeme******** inclusive.Additional requirements an******** may be assigned. At all t********employees are expecte******** adhere to company policies an******** SOPs.