Clinical Trial Activation Coordinator

Job Summary

The Huntsman Cancer Institute Clinical Trials Office (CTO) is hiring a coordinator to assist the Activation Project Administrator in various activation activities for oncology clinical trials conducted at Huntsman Cancer Institute. The coordinator will assist in evaluating new clinical trial opportunities for HCI with faculty principal investigators and clinical trial research managers and administrators.

Responsibilities

• Coordinates activation workflows to ensure appropriate timelines are met.
• Execution of confidentiality agreement for all clinical trial opportunities.
• Maintains trial activation resources, brochures and start-up materials for activation process.
• Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office.
• Serves as liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs.
• Provides regular reports on project status, certain metrics, and issues.
• Manages project deliverables. Tracks progress by keeping close metrics, including but not limited to time and quality. Be accountable for follow-up on action items. Works with the Project Administrator and Manager in identifying, resolving, or escalating issues.
• Represents the Clinical Trials Office in HCI Clinical Trial Research Group meetings.
• Completes intake Clinical Trial Research Group new study review and prioritization forms.
• Serves as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO.
• Establishes and fosters strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.
• Affords high quality of data and metrics to study sponsors and research teams.
• Aids in process and efficiency improvements in the trial activation area.
• Must be able to work independently and have strong communication and human relations skills.

Qualifications

• Bachelor's degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required.
• Demonstrated human relations and effective communication skills also required.
• One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.
• Bachelor's degree in a health sciences or related field with two years professional research experience in human subject research. Preferred.
• Oncology Clinical Trials Experience. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also preferred.
• Knowledge of FDA regulations relevant to drugs, devices, biologics.
• Previous working knowledge and experience with the pharmaceutical sponsors and contract research organizations.
• Attention to detail with excellent analytical and problem-solving skills.
• Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology in oncology.
• Ability to manage multiple tasks and set priorities and meet deadlines.
• Work within a team approach and be motivated to work consistently in a fast-paced, "customer-focused" environment.
• Excellent organizational and communication skills.
• Skilled in Microsoft Office.