Clinical Trials Coordinator
2 weeks ago
Position: Clinical Research Coordinator
Company: The Vascular Care Group
Summary
The Vascular Care Group is at the forefront of managing clinical trials for a distinguished network of vascular surgeons. Our portfolio includes both device and pharmaceutical trials, ranging from pioneering pilot studies to post-market registry evaluations. We leverage an advanced clinical trial management system that allows for the electronic storage of all subject and regulatory binders, significantly enhancing the remote oversight of trials and ensuring regulatory adherence.
This position plays a crucial role in facilitating the initiation of clinical trials and coordinating patient enrollment across our network.
Flexibility to travel between various sites is essential; primary work locations will include multiple practice sites as needed. The role is predominantly in-person (80%) with some remote responsibilities (20%).
Key Responsibilities
- Coordinate and lead weekly meetings with clinic and outpatient staff to review schedules and identify potential participants.
- Assist in evaluating patient records to determine eligibility for specific clinical research protocols.
- Monitor patients for any adverse reactions to study treatments, procedures, or medications, and alert the appropriate clinical staff for further evaluation.
- Manage device accountability, including the transportation or shipping of devices to practice sites as required.
- Gather necessary regulatory documentation for new trials and participate in training sessions related to these trials.
- Collect source data for entry into the Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) systems, addressing queries and collaborating with monitors to resolve issues.
- Support the onboarding and training of additional personnel to assist with various clinical trials.
- Ensure compliance with all Institutional Review Boards (IRB), FDA regulations, and other relevant federal, state, and industry standards.
- Assist in developing electronic templates within the CTMS for new trials to create electronic source documentation.
- Regularly travel to various offices to support trial initiation and patient enrollment activities.
Qualifications
- Bachelor's Degree in biological sciences, health sciences, social sciences, or a related medical field, or an equivalent combination of education and experience.
- Clinical experience in a surgical specialty is required; experience in vascular surgery is preferred.
- A minimum of one year of experience in a clinical research role or a solid understanding of clinical research processes is preferred.
- Familiarity with medical terminology is essential.
- Proficient computer skills are necessary, as much of the work involves accessing Electronic Medical Records and EDC systems.
- Attention to detail, proficiency with computer systems, ability to work independently, and a willingness to embrace challenges are crucial for success in this role.
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Clinical Trials Coordinator
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Wellesley, Massachusetts, United States The Vascular Care Group Full timeJob OverviewPosition: Clinical Research CoordinatorAbout UsThe Vascular Care Group specializes in managing clinical trials for a diverse range of vascular surgeons. Our trials encompass both device and pharmaceutical studies, including initial pilot studies, Investigational Device Exemption (IDE) trials, and post-market registry trials. We leverage an...
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Clinical Trials Coordinator
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Wellesley, Massachusetts, United States The Vascular Care Group Full timeJob OverviewPosition: Clinical Research CoordinatorCompany: The Vascular Care GroupSummaryThe Vascular Care Group is at the forefront of managing clinical trials for a distinguished network of vascular surgeons. Our trials encompass both device and pharmaceutical studies, ranging from initial pilot studies to post-market registry evaluations. We leverage an...
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