Join ERT's St Louis office as a Senior Data Coordinator where in addition to supporting our data query process, you will provide mentoring and training to new employees; lead process improvement efforts (including updates to SOPs and SWIs), and pilot new processes for the department. Responsibilities also include maintaining organized study documentation throughout the lifecycle of a study.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we 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. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than 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.
In this role, you will:
Support the team by serving as a mentor and trainer for new employees.
Pilot new processes and lead the effort to evaluate and document these processes as well as provide training for your colleagues on these processes.
Lead efforts to create, review, update and evaluate SOPs and SWIs including providing training to the global team on these SOPs and SWIs.
Support department workflow by taking action on discrepant data through investigation and issuance of queries to sites/sponsors to verify/obtain demographic and visit information on source data in accordance with departmental SOPs and SWIs
Investigate and enter resolutions and/or revisions received across operational systems
Process source data across operational systems and file source documents once workflow is complete
Maintain departmental metrics in accordance with goal plan
Assist as requested with data reconciliation activities for assigned studies ensuring that database updates are completed within the Sponsor requested timelines.
Attend Project Assurance meetings and outline feedback to Data Coordination
In addition to the items listed above, the Senior Data Coordinator may be asked to function at a team lead for the department. When functioning as the Lead, 50% of the Lead’s time is to be spent in production. The other lead duties include:
Monitor the daily workload of the team and ensure equal distribution of work to all team members adjusting assignments as needed to obtain operational efficiency.
Maintain daily communication between shifts focusing on deadlines, procedural changes, and workload demands.
Collect data to compile Quality Metrics for the group.
When requested, complete the weekly DC metrics.
Prepare client activity metrics as well as specific information related to problematic accounts for presentation and discussion at the Client Status Meetings
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.
Our ideal candidate will offer:
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.