Clinical Research Associate II

Simbec-Orion Group

Home-based, United Kingdom

THE ROLE

We are looking for a Clinical Research Associate II to join our Clinical Operations team where you will have previous experience in a clinical trial environment or have readily transferable skills and 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. (e.g., 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
Attends internal and external project calls as requested and per study budget providing requested site updates
Conduct pre-study visits, site initiation visits, monitoring visits and site closeout visits per SOPs/WPDs and study budget
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
Escalate in timely manner any issue related to Quality or Data integrity
Demonstrates working knowledge of applications and Systems (e.g., CTMS, eTMF, IVRS/IWRS and EDC)
Collaborates with other functional project leads (data management, medical monitoring, safety)
Facilitates site audits and resolves audit finding
May supervise work of, or mentor, less experienced CRAs
Serves as an observational visit leader

SKILLS REQUIRED

ESSENTIAL

Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent Clinical Research work experience
Previous experience of working as a Clinical Research Associate II in a CRO or Pharmaceutical setting
Experience as Clinical Research Associate
Good Communication & presentation Skills
Proficiency in written and spoken English, fluent in host country language
Good knowledge of regional clinical research regulations & ICH-GCP

DESIRABLE

Advanced degree (Masters, MD, PhD)
Ability to establish/maintain good working relationships with colleagues and clients
Proven ability to gain in-depth protocol knowledge

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