Research Study Start-Up Coordinator

Dartmouth-Hitchcock Health • Lebanon, NH

1d

About The Position

Responsible for managing clinical trial start-up activities and collaborating with internal and external stakeholders to activate protocols 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 through site activation.

Requirements

• Bachelor’s degree with 5 years of clinical research experience, or equivalent education and experience.
• Excellent organizational, writing, and office software skills.
• Excellent oral communication and interpersonal skills.
• Working knowledge of relevant FDA and ICH regulations and human-subject protection requirements.

Nice To Haves

• Previous project-related work involving complex scheduling and communications.

Responsibilities

• Organize and manage activities required for study activation, including feasibility, committee approvals, and regulatory information.
• Lead study site selection and start-up activities.
• Track studies in the department activation pipeline and meet with research teams to review progress and determine plans of action to prevent delays.
• Meet with the Regulatory team to review committee submission progress.
• Coordinate and attend Resource Meetings with the Clinical Trials Office and study team members, and ensure follow-up action items progress in a timely manner.
• Assist, as needed, with determining department personnel time for study budgets.
• Prepare or facilitate creation of study patient calendars in the clinical trials management system.
• Work with ancillary departments, including pathology, radiology, research laboratory, and investigational pharmacy, to ensure evaluations, documentation, and processes are completed to facilitate study activation.
• Track and manage activation processes and collaborate with stakeholders to resolve problems or delays promptly.
• Review site metrics routinely and evaluate procedures for process improvement opportunities.
• Report departmental activation metrics as needed.
• Prepare and submit study documents to sponsors and applicable regulatory agencies or oversight committees, as necessary.
• May be assigned data collection for patients in long-term follow-up.
• Perform other duties as required or assigned.

What This Job Offers

• Job Type: Full-time