Clinical Research Associate
2 days ago
We are seeking a skilled Clinical Research Coordinator to join our team at RUSH University Medical Center. As a key member of our clinical research administration division, you will play a vital role in ensuring the success of our clinical trials.
About the RoleThe successful candidate will be responsible for coordinating and managing multiple clinical research studies, including grant-funded, industry-sponsored, and investigator-initiated projects. This will involve working closely with Principal Investigators (PIs), Co-Investigators, study personnel, and sponsors to ensure protocols are conducted according to Good Clinical Practice (GCP) guidelines.
You will be responsible for implementing and executing study protocols, performing various study-related duties, and ensuring procedural documentation is accurate, complete, and compliant with institutional, local, state, and federal guidelines and regulations related to clinical research.
Key Responsibilities- Coordinate all aspects of the study, including recruitment, consent, screening, scheduling, tracking, and providing study updates to participants.
- Collect and enter data into case report forms and electronic data capture systems, responding to queries in a timely manner.
- Submit or partner with regulatory coordinators to submit study-related documents, study protocols, and amendments to the Institutional Review Board (IRB) per policy and procedure.
- Evaluate and improve complex processes related to the conduct of research studies.
To be successful in this role, you will need:
- A Bachelor's degree and 4 years of clinical research experience, or 8 years of experience in a related field.
- Advanced knowledge of Good Clinical Practices and Good Documentation Practices.
- Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
- Strong project management skills, including ability to meet deadlines and coordinate multiple aspects of ongoing projects.
- Problem-solving, critical decision-making, and professional judgment skills.
- Excellent analytical and organizational skills, with a high attention to detail.
- Ability to build rapport, navigate sensitive topics, and maintain confidentiality with diverse research participants and vendors.
- Strong verbal and written communication skills, with the ability to communicate complex concepts to multiple audiences.
- Availability to work evenings, overnight, and weekends as needed under study protocols.
- Travel may be required.
RUSH University Medical Center offers a competitive salary and benefits package, including health insurance, retirement savings plan, and paid time off. We also offer opportunities for professional growth and development, as well as a collaborative and supportive work environment.
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