Senior Clinical Research Associate - REMOTE

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.
• Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs.
• 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.
• Collaborates with project functional leads as needed.
• Attends internal and external project calls as requested and per budget to proactively provide required site updates.
• 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, based on Mentoring program.
• Serve as an observational visit leader.
• Provide feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial.
• Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes.
• Can be involved in other tasks as assigned by Management, CTMs and PMs.
• Escalate in timely manner any issue related to Quality or Data integrity.
  
  
  

SKILLS REQUIRED

• Bachelors degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
• Previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals
• Good experience in CTMS, eTMF IXRS and EDC systems
• Previous CRO experience
• Excellent communication skills
• Strong presentation skills
• Proficiency in written and spoken English; fluent in host country language
• Good knowledge of regional clinical research regulations and ICH-GCP
• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge
• Ability to establish/maintain good relationships with sites/colleagues/clients
• Ability to make decisions independently / Strong problem-solving skills
• Highly developed mentoring and motivational skills.

Please apply on the Lifelancer platform at the below link for screening steps & quicker response.

https://lifelancer.com/jobs/view/d1bc07f2c5f754440df328e7b9f756b1