Position Summary:
Denali Health is seeking an experienced Senior Clinical Research Coordinator to join our dynamic research team. The Senior Clinical Research Coordinator will be responsible for overseeing the planning, coordination, and execution of clinical trials at our research site. The ideal candidate will have substantial experience in clinical research, strong leadership skills, and a deep understanding of regulatory requirements and study protocols.
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 preferred.Exper
- ience: Minimum of 3 years of clinical research coordination experience. Experience in multiple therapeutic areas or complex clinical trials is an advantage.Certi
- fications: Certification 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!
