Job Overview
Benefits
Health Insurance
Paid Time Off
Retirement Plan
Professional development opportunities
Employee wellness programs
flexible spending accounts
Life insurance
Job Description
The Kidney Transplant Team is a dedicated group of healthcare professionals committed to advancing medical research and improving patient outcomes in the field of kidney transplantation. This team operates within a reputable medical institution known for its cutting-edge research and patient-centered care. They focus on clinical trials and studies that aim to enhance the understanding, treatment, and management of kidney transplant patients. Their work supports the development of new therapies and protocols that can lead to better long-term results for transplant recipients. With a strong emphasis on compliance and ethical research practices, the team collaborates closely with various stakeholders including physicians, regulatory bodies, and sponsors to ensure the success and integrity of their studies.
The Clinical Research Coordinator I role within the Kidney Transplant Team is a vital position responsible for the coordination and management of clinical research studies. This role requires an individual who can work independently to screen potential patients for protocol eligibility and assist in presenting trial concepts and details that do not involve medical advice. The coordinator plays a critical part in the informed consent process, ensuring patients understand the procedures and implications before participation. The position demands meticulous attention to detail for accurate and timely documentation, data collection, entry, and reporting. This includes maintaining source documents, responding promptly to sponsor queries, and compiling reports on study progress, participant accrual, and workload.
In addition to study coordination, the Clinical Research Coordinator contributes to maintaining compliance with federal regulations including those set by the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) requirements. The role also involves organizing and participating in monitoring visits, site initiation visits, close-out visits, and audit activities. Effective communication with sponsors to address exceptions and protocol clarifications is essential.
The coordinator supports research operations by assisting in regulatory submissions such as adverse events, serious adverse events, protocol deviations, and safety letters. Other responsibilities may include regulatory and IRB duties, budgeting, and patient research billing and reconciliation. Upholding Good Clinical Practice (GCP) guidelines and maintaining patient confidentiality in accordance with HIPAA regulations are non-negotiable components of this role. Continuous education and training are an expectation to stay current with evolving standards and practices in clinical research. This full-time position offers a meaningful opportunity to contribute to impactful clinical studies in kidney transplantation while developing a strong foundation in clinical research coordination and regulatory compliance.
The Clinical Research Coordinator I role within the Kidney Transplant Team is a vital position responsible for the coordination and management of clinical research studies. This role requires an individual who can work independently to screen potential patients for protocol eligibility and assist in presenting trial concepts and details that do not involve medical advice. The coordinator plays a critical part in the informed consent process, ensuring patients understand the procedures and implications before participation. The position demands meticulous attention to detail for accurate and timely documentation, data collection, entry, and reporting. This includes maintaining source documents, responding promptly to sponsor queries, and compiling reports on study progress, participant accrual, and workload.
In addition to study coordination, the Clinical Research Coordinator contributes to maintaining compliance with federal regulations including those set by the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) requirements. The role also involves organizing and participating in monitoring visits, site initiation visits, close-out visits, and audit activities. Effective communication with sponsors to address exceptions and protocol clarifications is essential.
The coordinator supports research operations by assisting in regulatory submissions such as adverse events, serious adverse events, protocol deviations, and safety letters. Other responsibilities may include regulatory and IRB duties, budgeting, and patient research billing and reconciliation. Upholding Good Clinical Practice (GCP) guidelines and maintaining patient confidentiality in accordance with HIPAA regulations are non-negotiable components of this role. Continuous education and training are an expectation to stay current with evolving standards and practices in clinical research. This full-time position offers a meaningful opportunity to contribute to impactful clinical studies in kidney transplantation while developing a strong foundation in clinical research coordination and regulatory compliance.
Job Requirements
- High school diploma or GED
- 1 year clinical research related experience
- knowledge of Good Clinical Practice guidelines
- ability to work independently
- strong organizational and communication skills
- familiarity with FDA and IRB regulatory requirements
- proficiency in data collection and documentation
- basic understanding of patient confidentiality regulations
Job Qualifications
- High school diploma or GED
- 1 year clinical research related experience
- Bachelor’s degree in science, sociology, or related field preferred
- Certification in Clinical Research SOCRA or ACRP certification upon hire preferred
Job Duties
- Independent study coordination including screening of potential patients for protocol eligibility
- presenting non-medical trial concepts and details to the patients
- participating in the informed consent process
- scheduling patients for research visits and procedures
- documenting changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug on case report forms
- maintaining accurate source documents related to all research procedures
- accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries
- scheduling and participating in monitoring visits, site initiation visits, close-out visits, and auditing activities
- communicating with sponsors regarding exceptions and protocol clarifications
- compiling and reporting on each study including protocol activity, accrual data, workload, and other information
- presenting study information at regular research staff meetings
- notifying direct supervisor about concerns regarding data quality and study conduct
- working closely with regulatory coordinator or IRB to submit adverse events, serious adverse events, protocol deviations, and safety letters
- performing other regulatory or IRB duties, budgeting duties, and assisting with patient research billing and reconciliation
- ensuring compliance with FDA and local IRB
- maintaining research practices using Good Clinical Practice guidelines
- maintaining patient confidentiality according to HIPAA regulations
- participating in required training and education programs
Job Criteria
Experience
No experience required
Job Location
Your Profile Is Visible To Hiring Managers Across OysterLink.
We'll match you with best jobs
Get job offers faster
Search For More Opportunities:
How Candidates Get Hired Faster
Apply to 2–3 similar roles
Complete profile & get best matches
Check new opportunities daily
