Clinical Project Administrator
hace 1 mes
Job Summary:
We are seeking a skilled Clinical Project Administrator to join our team. As a Clinical Project Administrator, you will be responsible for providing instrumental support for the clinical trial, working closely with the clinical team to ensure overall site management and adherence to internal SOPs, policies, and local regulatory requirements.
Key Responsibilities:
- Partner with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies, and local regulatory requirements.
- Support the local study team in performing site feasibility and/or country feasibility.
- Maintain site level protocol information in Trial Management Systems (e.g., CTMS).
- In liaison with the LTM, ensure current versions of the required trial documents, trial-related materials, and supplies are provided to the investigational site within required timeframes.
- Work with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority approval process.
- Support the Trial Manager and Clinical Monitor in providing the current and complete documents requested by the IEC/IRB and HA.
- Support the TM & CM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files.
- Distribute, collect, review, and track regulatory documents, agreements, and training documentation.
- Collect and track Financial Disclosure information at appropriate time points.
- May contribute to process improvement including, but not limited to, representing functional area in process initiatives and contributing to optimization of daily processes.
- May be assigned as a coach and mentor to a less experienced CTA.
Requirements:
- Skills set corresponding with preferentially 2+ years relevant clinical trial experience or equivalent.
- Experienced in Clinical Trial Management Systems & TMF management.
- Experienced in Contracts management and negotiation.
- Proficient in English language.
- Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer, and PowerPoint).
- Strong interpersonal and negotiating skills.
- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
- Perform activities in a timely and accurate manner.
Why Work with Us:
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
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