Simbec Orion Group Ltd

In-House Clinical Research Associate

Remote, United States
11 Jan 2021
10 Feb 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Main Duties and Responsibilities:

We are looking for an In-House Clinical Research Associate to join our Clinical Operations department. You will be based remotely in the East Coast of the US.

You will be perform site identification, assist with distribution and collection of essential documents in accordance with the Green Light Process SOP and ICH-GCP. The IHCRA will support submissions to local regulatory authorities, localisation of patient-facing materials and assembly of the Investigator Site File. Throughout the duration of a Clinical Trial, the IHCRA supports the Clinical Research Associate and study team with in-house site management activities by tracking and providing status updates, up-to-date information and documents to Investigator sites, CRA/CTL and the Project Management team. During the closeout phase of a trial, an IHCRA ensures the completeness and compliance of (e)TMF, as per the applicable SOPs.

Minimum Requirements:

  • Previous clinical research experience (eg. CTA, site coordinator, etc.)
  • Excellent written and verbal English communication skills; fluent in host country language
  • Strong computer skills, proficiency with MS Office Word/Excel

  • Undergraduate degree in Nursing, Life Sciences or equivalent work experience
  • Experience with CTMS/eTMF/EDC systems
  • Good knowledge of ICH-GCP
  • Ability to be flexibe and multitask

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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