# Senior Clinical Research Coordinator

**Company**: Topography
**Location**: Ann Arbor
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Research
**Industry**: Healthcare

**Apply**: https://jobs.lever.co/jointopo/5ca87b21-9f36-41e0-b846-4bef140256b4
**Canonical**: https://yubhub.co/jobs/job_b5658e2f-c9d

## Description

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.

The ideal candidate will have a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers.

Key responsibilities include:
Acting as senior study coordinator to execute trials conducted within physician practices,
Conducting patient recruitment and enrollment of eligible patients,
Leading patient study visits, which may also include clinical and lab procedures,
Independently administering the informed consent process with care and quality,
Ensuring protocol adherence and high data integrity,
Providing high quality source data capture and documentation,
Supporting study start-up and planning, including PSVs and SIVs,
Facilitating monitoring visits (IMVs) and sponsor correspondence,
Managing the follow-up process,
IP management, dispensation and accountability,
Adverse Event management, tracking, and follow-up,
Data entry to CRF/EDC and query resolution in a timely manner,
Supporting study close-out, including COVs,
Protocol deviation tracking, reporting, and reconciliation,
Training and mentoring junior research staff,
Using and helping improve Topography’s proprietary tool set,
Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including our SOPs,
Ensuring adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation,
Conducting Quality Control activities including routine QC checks during and following study visits,
Any other duties assigned by manager.

## Skills

### Required
- Clinical Research Coordinator
- Research Assistant
- FDA regulations
- ICH/GCP guidelines
- Data entry
- CRF/EDC
- Query resolution
- Study start-up
- Planning
- Monitoring visits
- Sponsor correspondence
- IP management
- Dispensation
- Accountability
- Adverse Event management
- Tracking
- Follow-up
- Quality Control
- Regulations
- Policies
- Guidelines
- SOPs