Senior Clinical Research Associate

Employer
Simbec Orion Group Ltd
Location
Remote, United States
Salary
Competitive
Closing date
19 Sep 2020

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
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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 a Senior Clinical Research Associate to join our Clinical Operations department. You will be based remotely in the US covering sites across the Mid-West and Central US.

You will be responsible for the set up of sites, budget proposals, and liaising with relevant authorities to ensure approvals are in place. Reporting into the CRA Manager and working under the supervision of the Clinical Trial Lead (CTL) and the Project Manager (PM) to conduct pre-study visits, Site Initiation, monitoring of clinical trials and close-out of investigator sites on complex studies run by Simbec-Orion. You will work closely with sponsors, project managers and other members of the study team to ensure study deliverables are met within the project timelines.

Minimum Requirements:

Essential:

  • Bachelor's degree in life Sciences or related fields
  • Previous experience as a CRA II
  • In-depth knowledge of European clinical research regulations, GCP, and ICH
  • Strong problem solving skills
  • Multiple therapeutic experience and demonstratable ability to understand complex protocols.
  • Deliver results to the appropriate quality and timeline metrics
  • Ability to establish and maintain effective working relationships with colleague and clients
  • Competent in clinical trial planning and metrics management


Desirable:
  • Subject matter expert in CTMS and/or eTMF systems
  • Advanced Degree (Masters, MD, Phd)
  • Previous experience working as a Senior Clinical Research Associate

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.

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.

Please click here to see members of Our Board and Senior Management Team

 

 

 

Fabrice Chartier, CEO. Discover how our team can work with you to provide innovative solutions to the most challenging clinical trials, in the most efficient, cost effective ways.

CEO - Fabrice Chartier

 

Contact Us
  • Merthyr Tydfil Industrial Park
  • Cardiff
  • CF48 4DR
  • United Kingdom
  • +44 1443 690977
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