ESSENTIAL DUTIES AND RESPONSIBILITIES:
This position requires a minimum of 50% of the employees 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.
OTHER DUTIES AND RESPONSIBILITIES:
The remaining 50% of the employees 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.
- 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.
QUALIFICATIONS AND SKILLS NEEDED:
(Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.)
Education:
- BS or BA degree in life sciences or related field or 3-4 years departmental or related experience.
Experience:
- Strong investigational and documentation skills.
- Positive mentor to new and existing team members with ability to motivate co-workers.
- Detail oriented, with ability to prioritize.
- Ability to adapt to shifting demands.
- Excellent organizational, communication and computer skills.
- Good presentation skills.
