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Lead Data Coordinator

Company: eResearch Technology
Location: Rochester
Posted on: May 16, 2020

Job Description:

LEAD DATA COORDINATOR

Job Location US-NY-Rochester

Shift

Full Time

Type

Regular Full-Time

OVERVIEW

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 standards.

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.



RESPONSIBILITIES

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 Clarification Requests.

* 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 for EXPeRT

* 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 follows:

* Monitors daily workflow of the Data Coordination and Data Acquisition Team.

* 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 operational efficiencies.

* Training.

* 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 department.

* Assists in performing the 6 month evaluations for all new Data coordination members.

* 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 shift

* Communicates deadlines.

* Keeps all shifts adequately informed about procedure changes and workload demands.

* Assists in the development and maintenance of department SOPs and Working Practices.

* 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 Application.

* 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 data

* 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 staff performance



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.

QUALIFICATIONS

Education:

* BS or BA degree in life sciences or related field or 3-5 years departmental or related
experience

Experience and skills:

* Strong investigational and documentation skills

* Positive mentor to new and existing team members with ability to motivate coworkers

* 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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