Clinical Research Associate II

Remote, Italy; Homeworking
Competitive
14 Sep 2022
14 Oct 2022
1094976526
Full Time
Permanent
Experienced (non-manager)
ABOUT US

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 the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE

We are looking for a Clinical Research Associate II to join our Clinical Operations team where you will be responsible for conducting site visits independently. You will monitor the progress of clinical trials with investigators onsite or remotely to ensure clinical trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP.

KEY ACCOUNTABILITIES

  • Contribute to site identification and feasibility activities.
  • Responsible for all aspects of study site management. (eg. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc.).
  • Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File.
  • Conduct pre-study visits, site initiation visits, site monitoring visits and site closeout visits.
  • Assesses IP accountability, dispensation, and compliance at the investigative sites.
  • Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
  • Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
  • Facilitates site audits and audit finding resolutions.
  • May supervise work of, or mentor, less experienced CRAs.
  • Serve as an observational visit leader.


SKILLS REQUIRED

Essential
  • Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience
  • Experienced Clinical Research Associate or equivalent relevant experience
  • Excellent communication skills
  • Proficiency in written and spoken English and fluent in host country language
  • Good knowledge of European clinical research regulations and ICH-GCP


Desirable
  • Advanced degree (Masters, MD, PhD)
  • CRA II experience in a CRO or Pharmaceutical setting
  • Strong presentation skills
  • Ability to establish/maintain good working relationships with colleagues and clients
  • Proven ability to gain in-depth protocol knowledge


WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.