Job Description

Overview

Responsible for managing the startup activities of clinical trials. Collaborates with internal and external stakeholders with responsibility for protocol activation in alignment with departmental and D-HH goals. Serves as the primary responsible party and point of contact during clinical research trial feasibility, planning, and implementation stages up until the point of site activation.

Responsibilities

Organizes and manages implementation of activities required for the study activation process, including, but not limited to feasibility, committee approvals, and regulatory information.

Leads study site selection and start-up activities.

Responsible for tracking progress of all studies in the department activation pipeline and meets with the research teams to review the studies’ progress and determine plan of action to ensure study startup is not delayed.

Meets with Regulatory team to review progress of committee submissions.

Coordinates and attends all Resource Meetings held with the Clinical Trials Office and study team members. Ensures follow-up action items are progressing in a timely manner.

May assist with the determination of department personnel time for study budgets.

Prepares or facilitates the creation of study patient calendars in the clinical trials management system.

Works with ancillary departments (e.g. pathology, radiology, research laboratory, investigational pharmacy) to ensure all necessary evaluations, documentation, and processes are provided and/or completed to facilitate study activation.

Tracks and manages the activation process and collaborates with stakeholders to assure timely resolution of problems and/or delays.

Routinely reviews site metrics and evaluates current procedures for process improvement opportunities.

Reports out departmental activation metrics as needed.

Prepares and submits study documents to study sponsors and any applicable regulatory agencies or oversight committees, as necessary.

May be assigned to data collection for patients in long-term follow-up.

Performs other duties as required or assigned.

Qualifications

• Bachelor’s degree with 5 years of clinical research experience, or the equivalent in education and experience, required.
• Excellent organizational, writing, and office software skills required.
• Excellent oral communication and interpersonal skills.
• Previous project related work involving complex scheduling and communications preferred.
• Maintains a working knowledge of relevant Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) regulations and human subject’s protection requirements.

Required Licensure/Certifications

• None