This role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run.
Requirements
- Act as study coordinator to execute trials conducted within physician practices
- Conduct patient recruitment and enrollment of eligible patients
- Independently administer the informed consent process with care and quality
- Ensure protocol adherence and high data integrity
- Provide high quality source data capture and documentation
- Attend study start-up and planning meetings
- Facilitating monitoring visits and sponsor correspondence
- IP management, dispensation and accountability
- Adverse Event management, tracking, and follow-up
- Data entry to CRF/EDC and query resolution in a timely manner
- Support study close-out, including COVs
- Protocol deviation tracking, reporting, and reconciliation
- Using and helping improve Topography’s proprietary tool set
- Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs
- Assist in Quality Control activities including routine QC checks during and following study visits