Job Summary:

The Clinical Trials Assistant supports both ongoing and upcoming Oncology clinical trials. Responsibilities include assisting the study lead in trial management, tracking oversight of vendors and samples, cleaning to ensure consistency and quality, and pulling/maintaining study metrics/reports.

Duties/Responsibilities:

• Understands medical terminology and has good attention to detail and quality.
• Reconciles files and processes digital and paper files related to study conduct.
• Works well in team structure but can also be self-directed and assertive.
• Provides administrative support to the clinical operations team.
• Ensures timely and accurate study-related communication to internal and external study teams.
• Assists with creating and reviewing study-specific documents, CRFs, manuals, newsletters, tools, templates, etc.
• Ensures the study coordinators and CRO staff adhere to the established clinical protocols, regulatory requirements, and Good Clinical Practice.
• Assists with study logistics, sample tracking, and report creation.
• Assists with the development and implementation of site-specific recruitment plans.
• Assists with site feasibility, qualification, and selection process; manages study monitoring schedule in collaboration with the CRO, and audits CRFs for conformity to source documentation.
• Assists with data entry and monitoring related target timelines and support timelines.
• Helps create monitoring and site management related clinical trial tracking metrics and reporting for internal and external collaborators.
• Participates in the selection and management/oversight of external vendors and assists in the development of vendor specifications.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry, or other life science field of study; or an LVN, RN, PA, or other licensed health-care professional degree.

• Minimum 1 year of experience directly supporting clinical research trials with a pharmaceutical company or CRO.
• Ability to travel up to 10% of the time to clinical sites.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.