Opportunity to be a part of the leading in-vitro diagnostics partner trusted in the market to successfully lead the most innovative diagnostic technology through clinical and regulatory approvals. With an autonomic approach enabled, you'll be identifying, evaluating, and ultimately establishing trial sites for the sponsor partners to accelerate the approval of their diagnostic technology.
- Working closely with industry leaders, you'll be drafting and providing input into their Clinical Study Protocols and supporting plans and procedures.
- Writing, reviewing, and editing Informed Consent Forms (ICFs), Monitoring Plans and Data Collection Forms in conjunction with the assigned Project Team.
- Assist with Institutional Review Board (IRB) submissions.
- Manage study budget, Trial Master Files, and agreements with study sites.
- Train site staff on protocol requirements, proper source documentation and case report form completion.
- Bachelor's degree in a health care or other scientific discipline or educational equivalent.
- 5+ years’ relevant clinical study experience in the medical devices industry or pharmaceuticals industry with specific experience in in vitro diagnostic devices a plus.
- ACRP or similar certification a plus but not required.
- Ability to manage multiple projects at a time from a consultative point-of-view
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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