Clinical Research Coordinator Associate
3 days ago
Tekberry is seeking a highly qualified and motivated individual to work with our client, a world-class university and research center.
As a W2 employee, you will have access to health benefits, including health, dental, and vision coverage, eligible on the first of the month following your start date.
Job Responsibilities:- Serve as primary contact with research participants, sponsors, and regulatory agencies for research projects within our Lung Transplantation team.
- Recruit, screen, and consent participants, and coordinate protocol study visits and reviews adverse events with research participants, the PIs, Clinical Research Manager, sponsors, and regulatory agencies.
- Responsible for regulatory oversight, initiating and maintaining IRB submissions, monitoring weekly billing reports, and coordination of site initiation, monitor, and close-out visits.
- Screen patients in the Lung Transplant clinics, and recruit participants for drug, tissue repositories, and observational Lung Transplant studies.
- Collect and manage patient and laboratory data for clinical research projects.
- Manage research project databases, develop flow sheets, and other study-related documents, and complete study documents/case report forms.
- Enter study data into existing electronic databases in accordance with each protocol's guidelines.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.
- Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
- Address and resolve study queries, protocol deviations, or other audit or monitoring findings and reviews with a Research Manager as needed.
Desired qualifications include experience with interventional drug treatment trials, clinical experience with patients with pulmonary disease, and completion of a clinical trials certification program or related courses.
Two-year college degree and two years related work experience or a bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
Proficiency with Microsoft Office and knowledge of medical terminology are required.
Tekberry is an equal opportunity employer and welcomes applications from diverse candidates.
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