Lead Data Coordinator
Company: eResearch Technology
Posted on: May 16, 2020
LEAD DATA COORDINATOR
Job Location US-NY-Rochester
ERT Rochester is looking to hire a Lead Data Coordinator. This
person will work with team members to ensure both company and
department SOPs and Working Practices are being followed. They will
ensure protocol compliance according to documented protocol
requirements. Will conduct initial training of new team members.
Will maintain production and quality metrics for team members. Will
direct the daily workflow of the team by monitoring queues and work
assignments to ensure all team tasks are completed daily.
ERT is a global data and technology company that minimizes
uncertainty and risk in clinical trials so that our customers can
move ahead with confidence. With more than 45 years of clinical and
therapeutic experience, ERT balances knowledge of what works with a
vision for what s next, so it can adapt without compromising
Powered by the company s EXPERT technology platform, ERT s
solutions enhance trial oversight, enable site optimization,
increase patient engagement, and measure the efficacy of new
clinical treatments while ensuring patient safety. Over the past
four years, more than half of all FDA drug approvals came from
ERT-supported studies. Pharma companies, Biotechs, and CROs have
relied on ERT solutions in 9,500+ studies spanning three million
patients to date. By identifying trial risks before they become
problems, ERT enables customers to bring clinical treatments to
patients quickly and with confidence. For more information, go to
ert.com or follow us on LinkedIn, Twitter, and Facebook.
This position requires a minimum of 50% of the employee s time be
spent performing operational tasks outlined below:
* Investigates and issues queries to sites/sponsors to
verify/obtain demographic and visit information on ECGs, Holters
and Flashcards/Transmittal Forms.
* Investigates and enters resolutions received from Data
* Maintains accurate and complete Data Coordination files for all
resolutions received, including filing signed DCFs and Data
Revision Request Forms in protocol
and/or investigator folders.
* Investigates and performs Self Evident Corrections as outlined in
the SEC Guidelines in the Data Coordination System Independent SWI
or documented in the
PRS. * Performs revisions received on Data Revision Request Forms
* Attends Project Assurance meetings and outlines feedback to Data
Coordination via email.
* Maintains minimum departmental metrics.
* Assists with the Data Entry, Scanning and Barcoding procedures
for the Data Acquisition team.
The remaining 50% of the employee s time will be allocated as
* Monitors daily workflow of the Data Coordination and Data
* Maintains an accurate assessment of existing and projected
workload and expected timelines.
* Ensures equal distribution of work to all team members.
* Adjusts team member assignments as required to maintain
* Trains new staff in the daily operations of the Data Coordination
Department. Trains current team members in any new procedures
necessary to facilitate the continued workflow of the
* Assists in performing the 6 month evaluations for all new Data
* Provides feedback through routine one-on-one meetings and writes
performance reviews for all Data Coordinators.
* Maintains daily communication between shifts.
* Communicates any issue that will need follow-up on another
* Communicates deadlines.
* Keeps all shifts adequately informed about procedure changes and
* Assists in the development and maintenance of department SOPs and
* Prepares client activity metrics (paper ECGs received and
processed, queries received and resolved, etc.) and any specific
information regarding problematic accounts for presentation and
discussion at Client Meetings.
* Attends, or sends a delegate to, all planning meetings.
* Record and distribute information relative to Data Coordination
activities to the team.
* Present Data Coordination issues.
* Mentors Data Coordinators on the nuances of query resolution and
issuance, including wording queries to sites/sponsor, researching
issues through EXPeRT systems and the Data Cleaning
* Oversee the daily functions of the query department to ensure
that metric goals are being achieved.
* Track and monitor employee productivity and quality metrics.
Coach DCs and DAA to achieve and exceed targets.
* Ensure all procedures and processes outlined in global SOPs and
SWIs are adhered to. Provide training on updated SOP/SWI and system
enhancements as appropriate.
* Ensure accurate and timely collection of demographic and visit
* Maintain workflow to meet turnaround time requirements by
monitoring system queues and reports as necessary
* Conduct monthly individual and team meetings to review metrics,
upcoming or outstanding work and both individual and departmental
goals and objectives
* Report to management the conduct, efficiencies and metrics for
The duties and responsibilities listed in this job description
represent the major responsibilities of the position. Other duties
and responsibilities may be assigned, as required. ERT reserves the
right to amend or change this job description to meet the needs of
ERT. This job description and any attachments do not constitute or
represent a contract.
* BS or BA degree in life sciences or related field or 3-5 years
departmental or related
Experience and skills:
* Strong investigational and documentation skills
* Positive mentor to new and existing team members with ability to
* Detail oriented, with ability to prioritize
* Ability to adapt to shifting demands
* Excellent organizational, communication and computer skills
* Good presentation skills
We are an equal opportunity employer and all qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, national origin, disability status, protected
veteran status, or any other characteristic protected by law.
Keywords: eResearch Technology, Rochester , Lead Data Coordinator, Other , Rochester, New York
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