Key Responsibilities:

• Study Coordination & Execution:
Overs
• ee the day-to-day execution of clinical trials, ensuring that protocols, maintaining and improving standard operating procedures (SOPs), and regulatory guidelines are adhered to.Serve
• as a point of contact between the study sponsor, PI, and research team.Coord
• inate the activities of the clinical research staff to ensure successful and timely completion of study milestones.
• Participant Management:
• Screen, enroll, and consent study participants in accordance with study protocols.
• Ensure study participants’ safety and well-being by monitoring adherence to study protocols and identifying and addressing adverse events or protocol deviations.
• Data Collection & Documentation:
• Collect, record, and manage clinical research data with accuracy and completeness in accordance with Good Clinical Practice (GCP) and sponsor requirements.
• Maintain comprehensive and organized records, including study logs, patient files, and study source documents.
• Regulatory Compliance & Reporting:
• Prepare and submit required regulatory documents, including IRB submissions, FDA forms, and protocol amendments.
• Ensure all study documentation is up-to-date, compliant with applicable regulations, and audit-ready.
• Collaborate with study monitors, auditors, and other external reviewers to facilitate study reviews and inspections.
• Team Leadership & Training:
• Mentor and provide guidance to junior research coordinators and support staff, ensuring effective team performance.
• Train new staff on study-specific protocols, research regulations, and site SOPs.
• Communication & Collaboration:
• Liaise with study sponsors, vendors, and internal stakeholders to facilitate effective study management and communication.
• Lead study-related meetings, including study initiation, monitoring, and close-out visits.

Qualifications:

• Education: Bachelor's degree in health sciences, nursing, or a related field. A Master’s degree is p
referred.Exper
• ience: Mini m um of 3 years of c linical research coordination experience. Experience in multiple therapeutic areas or complex clinical trials is an advantage.Certi
• fications: Cert ification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) preferred.
• Skills:
• Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial best practices.
• Strong leadership and project management skills.
• Excellent communication and interpersonal skills.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).

Why Join Denali Health?

We offer a collaborative work environment focused on advancing clinical research and improving patient outcomes. Denali Health provides competitive compensation, career growth opportunities, and a culture dedicated to innovation and excellence.

If you're ready to make a significant impact in clinical research and take on a leadership role, apply now!