Clinical Research Coordinator Associate
About the role
Join our Otolaryngology – Head and Neck Surgery department as a Clinical Research Coordinator Associate. You will be at the forefront of novel research projects spanning multiple divisions, contributing to breakthroughs that change lives. This onsite role offers the chance to oversee the lifecycle of diverse, high-impact clinical trials while being part of a visionary team that bridges novel research and world-class patient care.
We foster a supportive, collaborative, and inclusive environment where staff are treated like family, balancing the human side of medicine with cutting-edge science.
Responsibilities
- Serve as the primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- Coordinate the collection of study specimens and processing.
- 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.
- 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.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as the primary contact.
- Monitor expenditures and adherence to study budgets. Resolve billing issues in collaboration with finance and/or management staff.
- Interact regularly with the principal investigator to ensure patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
Requirements
- Two-year college degree and two years of related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
- Track record of successfully managing clinical trial projects with multiple stakeholders.
- Prior experience in clinical research working with Government and Industry Grants.
- Understanding of ethical standards for human subject research.
- Emotional intelligence to navigate a close-knit, family-oriented work culture while maintaining professional excellence.
Qualifications
- Bachelor of Science degree in biology, microbiology, health sciences, or nursing is desired.
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Physical Requirements
- Frequently: stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping.
- Occasionally: sit, reach above shoulders, perform desk-based computer tasks, use a telephone, write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely: kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, lift, carry, push, and pull objects that weigh 40 pounds or more.
Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of their job.
Working Conditions
- Occasional evening and weekend hours.
- Demonstrates the ability to work well with colleagues and external organizations.
- Promotes a culture of safety, demonstrating commitment to personal responsibility and safe behaviors.
- Compliance with all applicable University policies and procedures.