Clinical Research Associate II

ABOUT US

Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.

We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.

THE ROLE

We are looking for a Clinical Research Associate II to join our Clinical Operations team. 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.

You will attend study meetings, perform visits independently, and act as a site manager while working closely with Project Management, Clinical Trial Manager, and Data Management to ensure timely delivery of key study tasks.

KEY ACCOUNTABILITIES

• Contribute to site identification and feasibility activities.
• Responsible for all aspects of study site management (e.g., training site staff, ensuring 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.
• Attend 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.
• Assess 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 a timely manner any issues related to quality or data integrity.
• Demonstrate working knowledge of applications and systems (e.g., CTMS, eTMF, IVRS/IWRS, and EDC).
• Collaborate with other functional project leads (data management, medical monitoring, safety).
• Facilitate site audits and resolve audit findings.
• May supervise work of, or mentor, less experienced CRAs.
• Serve as an observational visit leader.

SKILLS REQUIRED

• 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 a Clinical Research Associate.
• Good communication and presentation skills.
• Proficiency in written and spoken English, fluent in host country language.
• Good knowledge of regional clinical research regulations and ICH-GCP.

• Advanced degree (Masters, MD, PhD).
• 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 a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralized leadership team.

With a focus on tailor-made and scalable solutions, we 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.