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Topography Health · 8 hours ago

Senior Clinical Research Coordinator

Ann Arbor, MI

Full-time

Onsite

Senior Level

5+ years exp

Topography Health is seeking a Senior Clinical Research Coordinator to lead and coordinate research efforts in a new research environment with cutting-edge technology. The role involves managing clinical trials, ensuring protocol adherence, and fostering relationships with healthcare providers while maintaining high data integrity and 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

Clinical Research CoordinationFDA RegulationsICH/GCP GuidelinesData Quality ManagementPatient RecruitmentCommunication SkillsTeamworkSelf-awarenessFlexibility