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Administrative Coordinator - Department of Research (Temporary)

Company: South Shore Health
Location: Weymouth
Posted on: January 12, 2022

Job Description:

Job Description Summary
The Administrative Coordinator (Department of Research) is responsible for coordinating all required components for requests to administer unauthorized medicine to treat patients with immediately life-threatening conditions or serious disease ("Emergency Use").
Job Description

It is the responsibility of the Administrative Coordinator to organize physicians seeking to use compassionate use of a drug/device and confirm treating physicians obtain IRB pre-approval prior to engaging the FDA and Sponsor. Following pre-approval, the Coordinator must adhere to internal and external protocols that govern the request process for compassionate use drugs/devices. Upon FDA and Sponsor approval, the Coordinator must ensure the treating physician obtains informed consent, to the extent possible, and that the consent documentation meets requirements. The Coordinator will be responsible for ensuring fully signed consent forms are scanned into patient charts and that all initial and follow up documents are submitted (e.g., FDA Form 3926, FDA close outs, IRB submissions). The Administrative Coordinator must ensure all physician requests and submissions comply with Food and Drug Administration (FDA), Sponsor and Institutional Review Board (IRB) requirements and that time sensitive documents are submitted in a timely fashion.

The Administrative Coordinator may be asked to liaise with family members to provide information and to schedule appointments/telephone calls with treating physicians. This role requires significant coordination with multiple departments at South Shore Health including the IRB, legal, pharmacy, medicine and infectious disease. The Administrative Coordinator will report to Stephanie Smith, Director of Research, and is expected to attend, and in some cases coordinate, internal meetings.

Supervisory Responsibilities : None

Patient Contact : adults and geriatrics 70+ years

Minimum Education : Candidates with a Bachelor's degree in a scientific, health related, or business administration program, preferred. At minimum, a candidate must have a Bachelor's degree.

Minimum Work Experience : Minimum 2-3 years in a clinical environment preferred

Required Licenses/Registrations : N/A Required Certifications : N/A

Required Classes/Skills : (Employees new to a position have 3 months to attain these required classes/skills)
Must be proficient in IRB, FDA and Sponsor reporting requirements within 3 months of hire
Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire.

Essential Functions : Ability to audit time sensitive documents in real time to avoid errors; develop and maintain a system to track all submissions, requirements and outstanding needs; assists physicians in tracking patient progress to assess for any potential adverse events or serious adverse events; and, ability to communicate with patients and their families in a busy hospital setting. Once fully trained, requires minimal supervision and is a self-starter.

Keywords: South Shore Health, Weymouth , Administrative Coordinator - Department of Research (Temporary), Administration, Clerical , Weymouth, Massachusetts

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