Clinical Trial Activation Coordinator

About the role

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. Responsibilities include evaluating new clinical trial opportunities with faculty principal investigators and research managers, facilitating strategic relationships with research partners, tracking confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking opportunities and outcomes. The role serves as a liaison with sponsors and vendors, assists with deliverables to multidisciplinary teams, oversees project agreements, and nurtures internal and external partnerships. Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship across Idaho, Montana, Nevada, Utah, and Wyoming, with global impact.

Responsibilities

• Coordinate activation workflows to ensure appropriate timelines are met.
• Execute confidentiality agreements for all clinical trial opportunities.
• Maintain trial activation resources, brochures, and start-up materials for the activation process.
• Complete feasibility questionnaires for clinical trials presented to the Clinical Trials Office.
• Serve as liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs; lead contact for all project matters; manage contractual and organizational client expectations; nurture client relationships and needs; provide sponsors with regular reports on project status, metrics, and issues.
• Manage project deliverables; track progress using metrics including time and quality; follow up on action items; work with the Project Administrator and Manager to identify, resolve, or escalate issues.
• Represent the Clinical Trials Office in HCI Clinical Trial Research Group meetings.
• Complete intake Clinical Trial Research Group new study review and prioritization forms.
• Submit trial packages to the Feasibility Administrative Review committee and follow up on action items to achieve approval.
• Liaise with the Office of Sponsored Projects and CTO Finance Pre-Award team to ensure appropriate and timely execution of CDAs, CTAs, and study budgets; assist in scheduling calls and supporting negotiations.
• Organize and actively participate in sponsor site visits in cooperation with research managers and administrators.
• Serve as an internal liaison to bridge trials from activation to start-up.
• Act as a liaison between study sponsors, HCI investigators, and the Clinical Trials Office by evaluating problems and providing solutions.
• Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
• Promote a positive work environment through open and effective communication.
• Serve as the first point of contact for potential outside CROs and sponsors; be the face of the HCI CTO.
• Establish and foster strong relationships and interactions with HCI investigators, study sponsors, and Clinical Trials Office personnel.
• Ensure high quality of data and metrics to study sponsors and research teams.
• Assist in process and efficiency improvements in the trial activation area.
• Work independently with strong communication and human relations skills.

Work Environment and Level of Frequency

• Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency

• Nearly Continuously: Sitting, hearing, listening, talking.
• Often: Repetitive hand motion (such as typing), walking.
• Seldom: Bending, reaching overhead.

Minimum Qualifications

• Bachelor’s degree in a research or related area plus two years of clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience).
• Demonstrated human relations and effective communication skills.
• One year of regulatory experience, an understanding of medical terminology, and technical writing experience preferred.
• This position is patient-sensitive and must fulfill all associated requirements, including immunization according to CDC standards and hospital policy, with limited exemptions for documented medical contraindications or religious beliefs.

Preferences

• Bachelor’s degree in a health sciences or related field with two years of 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.
• Knowledge of FDA regulations relevant to drugs, devices, and biologics.
• Previous working knowledge and experience with 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.
• Ability to 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.