Topography Health · 5 hours ago
Clinical Research Coordinator
Ann Arbor, MI
Full-time
Onsite
Mid, Senior Level
3+ years expTopography Health is innovating clinical research with a new architecture and technology team. The Clinical Research Coordinator will manage trials, ensure protocol adherence, and uphold data quality while fostering relationships with healthcare providers and patients.
Clinical TrialsConsultingHealth CareMedicalTherapeutics
Responsibilities
Act as study coordinator to execute trials conducted within physician practices, including but not limited to: Visit preparation activities
Visit follow-up activities
Supply and inventory management
Third party vendor coordination
Conduct patient recruitment and enrollment of eligible patients
Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc
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, including PSVs and SIVs
Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items
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
Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation
Assist in Quality Control activities including routine QC checks during and following study visits
Any other duties assigned by manager
Qualification
Required
Bachelor's degree or equivalent combination of training and experience
3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role
3+ years of experience independently coordinating studies, from study startup to close out
3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience
2+ years expert knowledge of FDA regulations and ICH/GCP guidelines
Company
Topography Health
Topography Health encourages physicians in private practice to participate in clinical trials in order to advance medical research.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$27.5MKey Investors
Bain Capital VenturesAndreessen Horowitz
2022-01-19Series A· $21.5M
2020-05-19Seed· $6M
Leadership Team
Alexander Saint-Amand
Co-Founder & CEO
Mac Parish
Co-Founder, Product
Recent News
2023-12-23
Crunchbase News
2022-10-18
Company data provided by crunchbase