Topography Health · 9 hours ago
Senior Clinical Research Coordinator
Ann Arbor, Michigan
Full-time
Onsite
Senior Level
5+ years expTopography Health is an innovative company focused on transforming clinical research through advanced technology. They are seeking a Senior Clinical Research Coordinator to lead and manage clinical trials, ensuring protocol adherence, high data quality, and a positive patient experience.
Clinical TrialsConsultingHealth CareMedicalTherapeutics
Responsibilities
Act as senior 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 management
Conduct patient recruitment and enrollment of eligible patients
Lead 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
Support study start-up and planning, including PSVs and SIVs
Support IRB submission and correspondence
Facilitate monitoring visits (IMVs) and sponsor correspondence including 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
Support study close-out, including COVs
Protocol deviation tracking, reporting, and reconciliation
Train and mentor junior research staff
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
Conduct 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
Ability to be on site 5 days a week in Chevy Chase, MD
5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role
5+ years of experience independently coordinating studies, from study startup to close out
5+ years demonstrated track record of delivering clean data and a high-quality patient experience
Expert knowledge of FDA regulations and ICH/GCP guidelines
Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
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